Infanrix IPV

INFANRIX-IPV+Hib powder and suspension for suspension for injection

Manufacturer: GlaxoSmithKline UK
Label last updated: 11 Nov 2024
Source: Official SmPC ↗

Five-in-one vaccine for babies from 2 months: diphtheria, tetanus, whooping cough, polio and Hib. No hepatitis B in this one.

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

Ingredients and materials

Diphtheria toxoid not less than 30 IU (25 Lf) and tetanus toxoid not less than 40 IU (10 Lf) per 0.5 ml doses.2
Three whooping cough antigens: pertussis toxoid 25 micrograms, filamentous haemagglutinin 25 micrograms, pertactin 8 microgramss.2
Inactivated poliovirus types 1 (Mahoney), 2 (MEF-1) and 3 (Saukett) at 40, 8 and 32 D-antigen units, propagated in VERO cellss.2
Haemophilus influenzae type b polysaccharide 10 micrograms, conjugated to tetanus toxoid as a carrier protein, approximately 25 microgramss.2
Aluminium hydroxide hydrated 0.5 mg Al3+ as an adsorbent adjuvants.2
May contain traces of formaldehyde, neomycin and polymyxin used during manufacture; hypersensitivity to any of them is a contraindications.2, 4.3
Para-aminobenzoic acid, less than 0.07 nanograms per dose, declared as an excipient with known effect: it may cause allergic reactions, possibly delayed, and exceptionally bronchospasms.2, 4.4
Phenylalanine 0.036 micrograms per dose, which may be harmful in phenylketonuria (PKU)s.2, 4.4
Other excipients: lactose, sodium chloride, Medium 199 (amino acids including phenylalanine, mineral salts, vitamins including para-aminobenzoic acid)s.6.1
Declared essentially sodium-free and potassium-free, less than 1 mmol of each per doses.4.4

Manufacture, storage and handling

Shelf life of the components before reconstitution is 3 yearss.6.3
After reconstitution the vaccine should be injected immediately; if not used immediately, in-use storage is the responsibility of the user and should normally not be longer than 8 hours at 2C to 8C in a refrigerators.6.3
Store at 2C to 8C, do not freeze, store in the original package to protect from lights.6.4
Supplied as two components - a Hib powder vial and a pre-filled syringe of DTPa-IPV suspension - reconstituted by injecting the syringe contents into the vial, shaking vigorously, then drawing the mixture back into the syringes.6.6
A white deposit and clear supernatant in the syringe on storage is not a sign of deteriorations.6.6
Do not pull the syringe plunger out of the barrel; if it happens, do not administer the vaccines.6.6
Deep intramuscular injection into the anterolateral thigh, preferably alternating limbs for subsequent dosess.4.2
Must under no circumstances be administered intravascularlys.4.2
Must not be mixed with other medicinal products; no compatibility studies exists.6.2
Administration should be recorded in the patient's International Vaccination Certificates.4.4

Safety findings

The safety and efficacy of this vaccine in children over 3 years of age have not been established, and the label states 'No data are available's.4.2
Contraindicated in hypersensitivity to the active substances, excipients, formaldehyde, neomycin or polymyxin, or after a previous reaction to any diphtheria, tetanus, pertussis, polio or Hib vaccines.4.3
Contraindicated if the child had an encephalopathy of unknown cause within 7 days of a previous pertussis-containing vaccines.4.3
Vaccination should be postponed during acute severe febrile illness; a minor infection is not a contraindications.4.3
If any of these followed a previous DTP-containing vaccine, further pertussis doses must be considered carefully: temperature of 40C or above within 48 hours, collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours, persistent inconsolable crying lasting 3 hours or more within 48 hours, or convulsions with or without fever within 3 days. The label notes there may be circumstances, such as a high incidence of pertussis, when potential benefits outweigh possible risks, particularly since the events are not associated with permanent sequelaes.4.4
According to available clinical data the risk of those reactions is lower with acellular pertussis vaccines than with whole cell pertussis vacciness.4.4
The Hib component does not protect against disease from other types of Haemophilus influenzae, nor against meningitis caused by other organismss.4.4
A history of febrile convulsions, a family history of convulsions, a family history of sudden infant death syndrome, and a family history of an adverse event after DTP, IPV or Hib vaccination do not constitute contraindicationss.4.4
HIV infection is not considered a contraindications.4.4
The expected immunological response may not be obtained in immunosuppressed patients, for example those on immunosuppressive therapys.4.4, 4.5
Excretion of capsular polysaccharide antigen in the urine has been described after Hib vaccines, so false positive antigen detection tests are possible within 1 to 2 weeks of vaccinations.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 delayed because the benefit is highs.4.4
Fainting can occur after, or even before, any vaccination as a response to the needle, so procedures should be in place to avoid injurys.4.4
Give with caution in thrombocytopenia or bleeding disorders because bleeding may follow intramuscular injection; firm pressure should be applied without rubbing for at least two minutess.4.2
Very common reactions: appetite lost, abnormal crying, irritability, restlessness, somnolence, fever of 38C or above, and pain, redness and local swelling at the injection sites.4.8
Post-marketing reports include allergic reactions including anaphylactic and anaphylactoid reactions, collapse or shock-like state, convulsions with or without fever, apnoea, angioneurotic oedema, swelling of the entire injected limb and injection site vesicless.4.8
Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after the booster than children primed with whole cell vaccines; these resolve over an average of 4 dayss.4.8
Local reactogenicity and fever increase after the booster compared with the primary courses.4.8
Pregnancy and lactation: the vaccine is not intended for use in adults, so information on safety in pregnancy or lactation is not availables.4.6
Overdose: some cases have been reported during post-marketing surveillance, and the events were similar to those after the recommended doses.4.9

Evidence and claims

After primary vaccination the proportion of infants reaching each antibody cut-off varies by schedule: for example anti-PRP (Hib) at the 0.15 microgram/ml cut-off ranged from 83.7 to 100 per cent, and at the higher 1.0 microgram/ml cut-off from 51.2 to 97.6 per cents.5.1
After booster vaccination, essentially all subjects reached the antibody cut-offs: anti-PRP at 1.0 microgram/ml was 96.7 per cent in one group and 99.2 per cent in anothers.5.1
Antibody cut-offs are described as 'accepted as indicative of protection' - a surrogate measure, not observed cases of diseases.5.1
Effectiveness of the Hib component was investigated in an extensive post-marketing surveillance study in Germany: over 4.5 years the effectiveness of DTPa+Hib or DTPa-IPV+Hib vaccines was 96.7 per cent for a full primary series and 98.5 per cent for a boosters.5.1
Over a seven year follow-up, the effectiveness of the Hib components of two hexavalent vaccines was 89.6 per cent for a full primary series and 100 per cent for a full primary series plus booster dose, irrespective of the Hib vaccine used for primings.5.1
Preclinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity and compatibility of ingredientss.5.3

Document and licensing

Marketing authorisation holder: SmithKline Beecham Ltd, London, trading as GlaxoSmithKline UKs.7
First authorised 25 January 2005, latest renewal 26 November 2012s.9
Text last revised 6 November 2024s.10
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 ↗

A 0.5 ml dose of vaccine contains:
 Diphtheria toxoid^1
 not less than 30 International Units (IU) (25 Lf)
 Tetanus toxoid^1
 not less than 40 International Units (IU) (10 Lf)
 Bordetella pertussis antigens
 Pertussis toxoid (PT)^1
 25 µg
 Filamentous haemagglutinin (FHA)^1
 25 µg
 Pertactin (PRN)^1
 8 µg
 Poliovirus (inactivated) (IPV)
 type 1 (Mahoney strain)^2
 40 D-antigen unit
 type 2 (MEF-1 strain)^2
 8 D-antigen unit
 type 3 (Saukett strain)^2
 32 D-antigen unit
 Haemophilus influenzae type b polysaccharide
 (polyribosylribitol phosphate) (PRP)
 10 µg
 conjugated to tetanus toxoid as carrier protein
 approximately 25 µg
 ^1Adsorbed on aluminium hydroxide, hydrated
 0.5 milligrams Al^3+
 ^2Propagated in VERO cells
 The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3).
 Excipients with known effect
 The vaccine contains para-aminobenzoic acid < 0.07 nanograms per dose and phenylalanine 0.036 micrograms per dose (see section 4.4).
 For the full list of excipients, see section 6.1.

What these are, in plain English

diphtheria toxoid - A diphtheria toxin that has been treated so it can no longer cause disease but still trains the immune system.
tetanus toxoid - A tetanus toxin that has been treated so it can no longer cause disease but still trains the immune system.
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.
vero - VERO cells: a laboratory-grown line of kidney cells originally taken from an African green monkey in 1962. Cells, not animal tissue, and they are not present in the finished vaccine.
formaldehyde - A chemical used to inactivate (kill) viruses or bacteria during manufacture. It is then removed, and only trace amounts can remain.
neomycin - An antibiotic used during manufacture to stop bacteria growing. Traces may remain, which is why a neomycin allergy is a contraindication.
polymyxin - An antibiotic used during manufacture. Traces may remain, which is why a polymyxin allergy is a contraindication.
para-aminobenzoic acid - A vitamin-like nutrient, sometimes called PABA, used to grow the cells.
phenylalanine - An amino acid. People with the inherited condition phenylketonuria (PKU) have to limit it, which is why it is declared.

Other ingredients (excipients)

Section 6.1 source ↗

Hib powder:
LactoseMilk sugar, used as a stabiliser and bulking agent.
DTPa-IPV suspension:A chelating agent, which grabs and holds trace metal ions that would otherwise break the vaccine down.
Sodium chlorideSalt. Used to keep the liquid at the same saltiness as the body.
Medium 199 (as stabilizer containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances)A standard laboratory nutrient mixture (salts, vitamins, amino acids, sugars) that cells are grown in. Its residues are diluted out almost entirely.
Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
For adjuvants, see section 2.

Audit trail: every flagged sentence in the document (9)

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

The safety and efficacy of INFANRIX-IPV+Hib in children over 3 years of age have 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.
- efficacy - How well it works in the controlled conditions of a trial.
Efficacy, effectiveness and endpointsNo data / not studied matched: efficacy, have not been established
No data are available.

Section 4.2 Posology and method of administration 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

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or formaldehyde, neomycin or polymyxin.

Section 4.3 Contraindications source ↗
In plain English
- hypersensitivity - An allergic-type reaction, from a mild rash up to a severe reaction.
Trace residues and process chemicals matched: formaldehyde

4.4 Special warnings and precautions for use

The Hib component of the vaccine does not protect against diseases due to other types of Haemophilus influenzae nor against meningitis caused by other organisms.

Section 4.4 Special warnings and precautions for use source ↗
In plain English
- meningitis - Inflammation of the lining around the brain and spinal cord.
Rare or very rare serious events matched: meningitis
A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) and a family history of an adverse event following DTP, IPV and/or Hib vaccination do not constitute contra-indications to administration of INFANRIX-IPV+Hib.

Section 4.4 Special warnings and precautions for use source ↗

Rare or very rare serious events matched: death

5.1 Pharmacodynamic properties

The effectiveness of the Hib component (when combined with DTPa, DTPa-IPV or DTPa-HBV-IPV) was investigated via an extensive post-marketing surveillance study conducted in Germany.

Section 5.1 Pharmacodynamic properties source ↗
In plain English
- post-marketing - After the product went on the market and was given to the public, as opposed to during the original clinical trials.
- effectiveness - How well it works in ordinary use in the real world.
Efficacy, effectiveness and endpoints matched: effectiveness
Over a 4.5 year follow-up period, the effectiveness of DTPa+Hib or DTPa-IPV+Hib vaccines was 96.7% for a full primary series and 98.5% for a booster dose (irrespective of priming).

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
Over a seven year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines was 89.6% for a full primary series and 100% for a full primary series plus booster dose (irrespective of the Hib vaccine used for priming).

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

6.6 Special precautions for disposal and other handling

If it happens, do not administer the vaccine.

Section 6.6 Special precautions for disposal and other handling source ↗
In plain English
- do not administer - The label instructs that it must not be given.
Not recommended, contraindicated or restricted matched: do not administer

Read the whole document at the source ↗