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Prevenar 13

Prevenar 13 suspension for injection

Manufacturer
Pfizer Limited
Label last updated
05 Jun 2025
Source
Official SmPC ↗

Pneumococcal vaccine covering 13 serotypes, for babies from 6 weeks and for adults. Its protection against invasive pneumococcal disease was never studied directly - it was inferred from comparison with the older 7-serotype vaccine.

56 findings, each with the section of the label it comes from.

Ingredients and materials

  • Thirteen pneumococcal polysaccharides, one per serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Twelve are at 2.2 micrograms per 0.5 ml dose; serotype 6B is at 4.4 microgramss.2
  • Each polysaccharide is conjugated to CRM197 carrier protein - a modified diphtheria toxin - and adsorbed on aluminium phosphates.2
  • Each dose contains approximately 32 micrograms of CRM197 carrier protein and 0.125 mg aluminiums.2
  • Because CRM197 is a diphtheria toxoid variant, hypersensitivity to diphtheria toxoid is a contraindications.4.3
  • Polysorbate 80, 0.1 mg per dose, declared as an excipient with known effect and itself able to cause hypersensitivity reactionss.2, 4.4
  • Excipients: sodium chloride, succinic acid, polysorbate 80, water for injectionss.6.1
  • Declared essentially sodium-free, less than 1 mmol (23 mg) per doses.4.4

Manufacture, storage and handling

  • Shelf life 3 yearss.6.3
  • Store at 2C to 8C, do not freezes.6.4
  • Stable at temperatures up to 25C for four days, but these data are intended to guide professionals in case of a temporary temperature excursion only; use or discard at the end of the periods.6.4
  • A white deposit and clear supernatant may be seen on storage; this does not constitute a sign of deteriorations.6.6
  • Intramuscular injection: anterolateral thigh in infants, deltoid in children and adultss.4.2
  • Must not be administered intravascularlys.4.4
  • Should not be given as an intramuscular injection to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the riskss.4.4
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • Schedules vary widely by age and prior vaccination: a three-dose primary series plus booster, or a two-dose primary series plus booster in routine programmes, or one single dose for 2 to 17 year olds previously vaccinateds.4.2
  • The need for revaccination with a subsequent dose in adults 'has not been established's.4.2

Safety findings

  • Protection is limited to the 13 serotypes in the vaccine: it will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media, and it may not protect all individualss.4.4
  • Protection against otitis media is expected to be lower than against invasive disease, and because otitis media has many other causes, protection against all otitis media 'is expected to be low's.4.4
  • Contraindicated in hypersensitivity to the active substances, the excipients, or to diphtheria toxoids.4.3
  • Vaccination should be postponed during acute severe febrile illness; a minor infection such as a cold is not a reason to defers.4.3
  • In clinical studies the immune response to serotype 3 after the booster dose was not increased above the levels seen after the infant series, and 'the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown's.4.4
  • Functional antibody titres (OPA) against serotypes 1, 3 and 5 were lower than those against the other additional serotypes, and 'the clinical relevance of this observation for protective efficacy is unknown's.4.4
  • A post-marketing study suggests that giving paracetamol with, or on the same day as, vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose at 12 months were unaffected, and the clinical significance is unknowns.4.5
  • When given with the trivalent flu vaccine, immune responses to Prevenar 13 were lower than when given alone, though with no long-term impact on circulating antibody levels; with the quadrivalent flu vaccine, responses to some pneumococcal serotypes were also lowers.4.5
  • Concomitant administration of Prevenar 13 and the 23-valent pneumococcal polysaccharide vaccine has not been studied, and when Prevenar 13 was given 1 year after the 23-valent vaccine the immune responses were lower for all serotypes. The clinical significance of this is unknowns.4.5
  • No data are currently available on concomitant use with other vaccines for children and adolescents aged 6 to 17 years, or for adults aged 18 to 49 yearss.4.5
  • There are no data from use in pregnant women and 'the use of Prevenar 13 should be avoided during pregnancy's.4.6
  • It is unknown whether the vaccine is excreted in human milks.4.6
  • Individuals with impaired immune responsiveness from immunosuppressive therapy, a genetic defect, HIV infection or other causes may have a reduced antibody responses.4.4
  • Safety and immunogenicity data are available for only a limited number of individuals with sickle cell disease, HIV infection or a haematopoietic stem cell transplant; data are not available for other immunocompromised groups such as malignancy or nephrotic syndrome, and vaccination should be considered on an individual basiss.4.4
  • There are no data to indicate whether giving the 23-valent polysaccharide vaccine to unprimed children, or to children primed with Prevenar 13, might result in hyporesponsiveness to further doses of Prevenar 13s.4.4
  • The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered in very premature infants born at or before 28 weeks, particularly those with previous respiratory immaturity; vaccination should not be withheld or delayeds.4.4
  • Antipyretic treatment should follow local guidelines for children with seizure disorders or a prior history of febrile seizures, and for all children receiving Prevenar 13 at the same time as vaccines containing whole cell pertussiss.4.4
  • In infants vaccinated at 2, 3 and 4 months, fever of 38C or above was reported at higher rates in those who received the 7-valent vaccine with Infanrix hexa (28.3 to 42.3 per cent) than with Infanrix hexa alone (15.6 to 23.1 per cent); after a booster at 12 to 15 months it was 50.0 per cent against 33.6 per cents.4.8
  • Analysis of post-marketing reporting rates suggests a potential increased risk of convulsions with or without fever, and of hypotonic hyporesponsive episode, when Prevenar 13 is given with Infanrix hexa compared with Prevenar 13 alones.4.8
  • Very common reactions in children: decreased appetite, fever, irritability, any vaccination-site redness, induration, swelling or pain, somnolence and poor quality sleeps.4.8
  • Listed as uncommon in children: convulsions including febrile convulsions, urticaria or urticaria-like rash, crying, vaccination-site swelling over 7.0 cms.4.8
  • Listed as rare in children: hypersensitivity reaction including face oedema, dyspnoea and bronchospasm, and hypotonic-hyporesponsive episodes.4.8
  • Post-marketing reports at frequency not known include lymphadenopathy, anaphylactic and anaphylactoid reactions including shock, angioedema, erythema multiforme, and vaccination-site urticaria, dermatitis, pruritus and flushings.4.8
  • A trend to a lower frequency of adverse reactions with greater age was seen in adults; severe vaccination-site pain and severe limitation of arm movement were very common in adults aged 18 to 39 and common in older groupss.4.8
  • Overdose, defined in infants and children as subsequent doses given closer than recommended to the previous dose, has been reported; adverse events were consistent with the recommended scheduless.4.9

Evidence and claims

  • 'The protective efficacy of Prevenar 13 against IPD has not been studied.' Assessment of potential efficacy in infants and young children was instead based on comparing immune responses to the seven serotypes shared with the 7-valent vaccine, for which protective efficacy has been provens.5.1
  • Based on serotype surveillance in Europe before the introduction of Prevenar, Prevenar 13 is estimated to cover 73 to 100 per cent, depending on country, of serotypes causing invasive pneumococcal disease in children under 5s.5.1
  • In children under 5, serotypes 1, 3, 5, 6A, 7F and 19A account for 15.6 to 59.7 per cent of invasive disease, depending on country, time period and prior use of Prevenars.5.1
  • Prevenar 13 is estimated to cover over 90 per cent of serotypes causing antimicrobial-resistant invasive pneumococcal diseases.5.1
  • In adults, surveillance data from after the introduction of Prevenar but before Prevenar 13 was used in childhood programmes suggests the serotypes in Prevenar 13 may be responsible for at least 50 to 76 per cent, depending on country, of invasive pneumococcal diseases.5.1
  • Serotype coverage data come from surveillance rather than from trials of the vaccine itselfs.5.1
  • The paediatric safety database is 14,267 doses given to 4,429 healthy infants in controlled studies, all co-administered with routine vaccines, plus 354 previously unvaccinated children aged 7 months to 5 yearss.4.8
  • Adult safety was assessed in 7 clinical studies including 91,593 adults aged 18 to 101; 48,806 received Prevenar 13s.4.8
  • Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, local tolerance, and reproduction and developmental toxicitys.5.3

Document and licensing

  • Marketing authorisation holder: Pfizer Limited, Sandwich, Kents.7
  • First authorised 9 December 2009, latest renewal 18 September 2014s.9
  • Text last revised June 2025s.10
  • The label states plainly that protective efficacy against invasive pneumococcal disease has not been studied, and that coverage estimates come from surveillances.5.1
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

1 dose (0.5 ml) contains:
 Pneumococcal polysaccharide serotype 1^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 3^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 4^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 5^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 6A^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 6B^1 
 4.4 µg
 Pneumococcal polysaccharide serotype 7F^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 9V^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 14^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 18C^1
 2.2 µg
 Pneumococcal polysaccharide serotype 19A^1
 2.2 µg
 Pneumococcal polysaccharide serotype 19F^1 
 2.2 µg
 Pneumococcal polysaccharide serotype 23F^1 
 2.2 µg
 ^1Conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate.
 1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein and 0.125 mg aluminium.
 Excipients with known effect 
 Prevenar 13 contains 0.1 mg of polysorbate 80 in each 0.5 ml dose, which is equivalent to 0.2 mg/ml of polysorbate 80.
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • crm197 - A carrier protein made from a modified diphtheria toxin. Harmless in this form, and used to carry a sugar antigen so the immune system notices it.
  • aluminium - An aluminium salt. It is an adjuvant: it makes the immune system respond more strongly to the vaccine. Aluminium in vaccines has been used since the 1930s.
  • polysorbate 80 - An emulsifier (E433), also used in some foods and cosmetics. It stops the ingredients separating.

Other ingredients (excipients)

Section 6.1 source ↗

  • Sodium chlorideSalt. Used to keep the liquid at the same saltiness as the body.
  • Succinic acidAn acid used to hold the liquid at a steady acidity.
  • Polysorbate 80An emulsifier (E433), also used in some foods and cosmetics. It stops the ingredients separating.
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
  • For adjuvant, see section 2.An added ingredient that makes the immune system react more strongly to the vaccine.
Audit trail: every flagged sentence in the document (69)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. Prevenar 13 contains the same 7 serotypes included in Prevenar, using the same carrier protein CRM197.

    Section 4.2 Posology and method of administration source ↗

    Adjuvants, carriers and immune-stimulating ingredients matched: carrier protein

  2. The need for revaccination with a subsequent dose of Prevenar 13 has not been established.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • not been established - There is not yet enough evidence to state a conclusion.

    No data / not studied matched: not been established

4.4 Special warnings and precautions for use

  1. Prevenar 13 must not be administered intravascularly.

    Section 4.4 Special warnings and precautions for use source ↗

    Not recommended, contraindicated or restricted matched: must not be administered

  2. This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1).

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • should not be given - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be given

  3. This medicinal product contains polysorbate 80 (see section 2).

    Section 4.4 Special warnings and precautions for use source ↗

    Trace residues and process chemicals matched: polysorbate

  4. Polysorbate 80 may cause hypersensitivity reactions.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • hypersensitivity - An allergic-type reaction, from a mild rash up to a severe reaction.

    Trace residues and process chemicals matched: polysorbate

  5. In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine.

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  6. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1).

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpointsNo data / not studied matched: immune response, is unknown

  7. However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown (see section 5.1).

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, is unknown

  8. Limited data have demonstrated that Prevenar 7-valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • limited data - Only a small amount of information exists on this point, so firmer conclusions cannot be drawn.

    Efficacy, effectiveness and endpointsLimited, insufficient or inconclusive matched: immune response, limited data

  9. There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar 13 might result in hyporesponsiveness to further doses of Prevenar 13.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

  10. Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or with a prior history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis.

    Section 4.4 Special warnings and precautions for use source ↗

    Rare or very rare serious events matched: seizure

4.5 Interaction with other medicinal products and other forms of interaction

  1. Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. The clinical significance of this observation is unknown.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    No data / not studied matched: is unknown

  3. No data are currently available regarding concomitant use with other vaccines.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

  4. No data are available regarding concomitant use with other vaccines.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

  5. The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Efficacy, effectiveness and endpoints matched: noninferior

  6. The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Efficacy, effectiveness and endpoints matched: noninferior

  7. Concomitant use with other vaccines has not been investigated.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    No data / not studied matched: not been investigated

  8. Concomitant administration of Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine has not been studied.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.

    No data / not studied matched: has not been studied

  9. The clinical significance of this is unknown.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    No data / not studied matched: is unknown

4.6 Fertility, pregnancy and lactation

  1. There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • conjugate - A design where a sugar from a germ is attached to a carrier protein, so the immune system responds properly.
    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

  2. Therefore the use of Prevenar 13 should be avoided during pregnancy.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Not recommended, contraindicated or restricted matched: should be avoided

  3. It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • conjugate - A design where a sugar from a germ is attached to a carrier protein, so the immune system responds properly.

    No data / not studied matched: is unknown

4.8 Undesirable effects

  1. The frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).

    Section 4.8 Undesirable effects source ↗

    In plain English

    • very common - In the label's frequency scale, this means it happened in more than 1 in 10 people studied.
    • very rare - In the label's frequency scale, this means it happened in up to 1 in 10,000 people. Often these are reports sent in after a vaccine is in use rather than findings from a formal study.
    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studiedRare or very rare serious events matched: not known, very rare

  2. The following are considered adverse drug reactions for Prevenar 13; because these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  3. Blood and lymphatic system disorders:

    Section 4.8 Undesirable effects source ↗

    Animal, human or cell-line derived material matched: blood

5.1 Pharmacodynamic properties

  1. Prevenar 13 contains the 7 pneumococcal capsular polysaccharides that are in Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F) plus 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A) all conjugated to CRM197 carrier protein.

    Section 5.1 Pharmacodynamic properties source ↗

    Adjuvants, carriers and immune-stimulating ingredients matched: carrier protein

  2. Bacteraemic pneumonia (approximately 80% of IPD in adults), bacteraemia without a focus, and meningitis are the most common manifestations of IPD in adults.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • meningitis - Inflammation of the lining around the brain and spinal cord.
    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Rare or very rare serious events matched: meningitis

  3. The protective efficacy of Prevenar 13 against IPD has not been studied.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, has not been studied

  4. As recommended by the World Health Organization (WHO) the assessment of potential efficacy against IPD in infants and young children has been based on a comparison of immune responses to the seven common serotypes shared between Prevenar 13 and Prevenar, for which protective efficacy has been proven (for Prevenar (7-valent) efficacy in infants and children, see below).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.
    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Efficacy, effectiveness and endpoints matched: efficacy

  5. In these two studies pneumococcal immune responses were compared using a set of non-inferiority criteria including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG ≥ 0.35 μg/ml one month after the primary series and the comparison of IgG geometric mean concentrations (ELISA GMCs); in addition, functional antibody titres (OPA) between subjects receiving Prevenar 13 [...]

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • non-inferiority - A trial designed to show a new vaccine is not worse than an existing one, rather than that it is better.
    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  6. The non-inferiority immune response comparisons for study 006, based on the proportion of infants achieving anti-polysaccharide IgG concentrations ≥ 0.35 μg/ml, are shown in Table 1.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • non-inferiority - A trial designed to show a new vaccine is not worse than an existing one, rather than that it is better.

    Efficacy, effectiveness and endpoints matched: immune response

  7. The clinical relevance of these differences is not known.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  8. The functional antibody (OPA) geometric mean titres for serotypes 1, 3 and 5 were lower than the titres for each of the other additional serotypes; the clinical relevance of this observation for protective efficacy is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, is unknown

  9. The OPA geometric mean titres for serotypes 1, 3 and 5 were lower than the titres for each of the other additional serotypes; the clinical relevance of this observation is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpointsNo data / not studied matched: geometric mean, is unknown

  10. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpointsNo data / not studied matched: immune response, is unknown

  11. It is unknown whether immunological memory to all serotypes is induced in pre-term infants.

    Section 5.1 Pharmacodynamic properties source ↗

    No data / not studied matched: is unknown

  12. In both the children 5 to 10 years of age and children and adolescents aged 10 to 17 years, the immune response to Prevenar 13 was non inferior to Prevenar for the 7 common serotypes and to Prevenar 13 for the 6 additional serotypes compared to the immune response after the fourth dose in infants vaccinated at 2, 4, 6 and 12-15 months of age as measured by serum IgG.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Efficacy, effectiveness and endpoints matched: immune response

  13. In children and adolescents aged 10 to 17 years of age OPA GMTs 1 month after vaccination were noninferior to OPA GMTs in the 5 to 10 year old age group for 12 of the 13 serotypes (except serotype 3).

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: noninferior

  14. The reductions ranged between 34% and 62% depending on serotype and antibiotic.

    Section 5.1 Pharmacodynamic properties source ↗

    Trace residues and process chemicals matched: antibiotic

  15. Prevenar (7-valent vaccine) protective efficacy in infants and children

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  16. The efficacy of 7-valent Prevenar was evaluated in two major studies - the Northern California Kaiser Permanente (NCKP) study and the Finnish Otitis Media (FinOM) study.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  17. The efficacy results from these studies (for invasive pneumococcal disease, pneumonia, and acute otitis media) are presented below (Table 3).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  18. The effectiveness (both direct and indirect effect) of 7-valent Prevenar against pneumococcal disease has been evaluated in both three-dose and two-dose primary infant series immunisation programmes, each with booster doses (Table 4).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  19. Using the screening method, serotype-specific effectiveness estimates for 2 doses under the age of 1 year in the UK were 66% (-29, 91%) and 100% (25, 100%) for serotype 6B and 23F, respectively.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  20. Summary of effectiveness of 7-valent Prevenar for invasive pneumococcal disease

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  21. Calculated vaccine effectiveness as of June 2008 (Broome method).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  22. Complete effectiveness for routine 2+1 schedule not yet available.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  23. Effectiveness of Prevenar in a 3+1 schedule has also been observed against acute otitis media and pneumonia since its introduction in a national immunisation programme.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  24. Efficacy study in adults 65 years and older

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  25. Efficacy against vaccine-type (VT) pneumococcal CAP and IPD was assessed in a large-scale randomised double-blind, placebo-controlled study (Community-Acquired Pneumonia Immunization Trial in Adults-CAPiTA) in the Netherlands. 84,496 subjects, 65 years and older received a single vaccination of either Prevenar 13 or placebo in a 1:1 randomisation.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • placebo-controlled - A trial where one group gets a dummy instead of the vaccine, so the two can be compared.
    • randomised - A trial where people are assigned to groups by chance.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  26. Efficacy was demonstrated for the primary and secondary endpoints in the per protocol population (Table 5).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  27. Vaccine efficacy (VE) for the primary and secondary endpoints of the CAPiTA study (per protocol population)

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  28. The duration of protective efficacy against a first episode of VT pneumococcal CAP, NB/NI VT pneumococcal CAP, and VT-IPD extended throughout the 4-year study.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  29. The study was not designed to demonstrate efficacy in subgroups, and the number of subjects ≥ 85 years of age was not sufficient to demonstrate efficacy in this age group.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  30. A post-hoc analysis was used to estimate the following public health outcomes against clinical CAP (as defined in the CAPiTA study, and based on clinical findings regardless of radiologic infiltrate or etiologic confirmation): vaccine efficacy (VE), incidence rate reduction (IRR), and number needed to vaccinate (NNV) (Table 6).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  31. For all pivotal clinical trials, a serotype-specific opsonophagocytosis assay (OPA) was used as a surrogate to assess potential efficacy against invasive pneumococcal disease and pneumonia.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • surrogate - A stand-in measurement used instead of the outcome you actually care about.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  32. OPA geometric mean titers (GMTs) measured 1-month after each vaccination were calculated.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  33. Pivotal trials for Prevenar 13 were designed to show that functional OPA antibody responses for the 13 serotypes are non-inferior, and for some serotypes superior, to the 12 serotypes in common with the licensed 23-valent pneumococcal polysaccharide vaccine [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] one month after vaccine administration.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Efficacy, effectiveness and endpoints matched: non-inferior

  34. In adults aged 60-64 years, OPA GMTs to Prevenar 13 were non-inferior to the OPA GMTs elicited to the 23-valent pneumococcal polysaccharide vaccine for the twelve serotypes common to both vaccines.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Efficacy, effectiveness and endpoints matched: non-inferior

  35. In adults aged 50-59 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: non-inferior

  36. ^c Confidence intervals (CIs) for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • confidence interval - The range of results within which the true figure is likely to sit. A wide range means the result is less certain.

    Efficacy, effectiveness and endpoints matched: confidence interval

  37. In adults aged 18-49 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: non-inferior

  38. In adults vaccinated with pneumococcal polysaccharide vaccine at least 5 years prior to the clinical study, OPA GMTs to Prevenar 13 were non-inferior to the 23-valent pneumococcal polysaccharide vaccine responses for the 12 serotypes in common.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Efficacy, effectiveness and endpoints matched: non-inferior

  39. The clinical relevance of the antibody levels elicited by Prevenar 13 in these special populations is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    No data / not studied matched: is unknown

  40. Subjects who received two or more previous doses of 23-valent pneumococcal polysaccharide vaccine showed a similar immune response compared with subjects who received a single previous dose.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

6.1 List of excipients

  1. For adjuvant, see section 2.

    Section 6.1 List of excipients source ↗

    In plain English

    • adjuvant - An added ingredient that makes the immune system react more strongly to a vaccine.

    Adjuvants, carriers and immune-stimulating ingredients matched: adjuvant

6.6 Special precautions for disposal and other handling

  1. Do not use if the content appears otherwise.

    Section 6.6 Special precautions for disposal and other handling source ↗

    Not recommended, contraindicated or restricted matched: do not use

Read the whole document at the source ↗