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Infanrix hexa

Infanrix hexa, Powder and suspension for suspension for injection.

Manufacturer
GlaxoSmithKline UK
Label last updated
07 Apr 2025
Source
Official SmPC ↗

Six-in-one vaccine for babies from 6 weeks: diphtheria, tetanus, whooping cough, hepatitis B, polio and Hib, in one injection.

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

Ingredients and materials

  • Diphtheria toxoid not less than 30 IU and tetanus toxoid not less than 40 IU per 0.5 ml doses.2
  • Three whooping cough (pertussis) antigens: pertussis toxoid 25 micrograms, filamentous haemagglutinin 25 micrograms, pertactin 8 microgramss.2
  • Hepatitis B surface antigen 10 micrograms, produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technologys.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
  • Two aluminium adjuvants: aluminium hydroxide hydrated at 0.5 mg Al3+ and aluminium phosphate at 0.32 mg Al3+s.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, 0.057 nanograms per dose, declared as an excipient with known effect: it may cause allergic reactions, possibly delayed, and exceptionally bronchospasms.2, 4.4
  • Phenylalanine 0.0298 micrograms per dose, which may be harmful in phenylketonuria (PKU)s.2, 4.4
  • Other excipients: lactose anhydrous, 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 4 yearss.6.3
  • After reconstitution immediate use is recommended, although stability has been demonstrated for 8 hours at 21Cs.6.3
  • Store at 2C to 8C, do not freeze, store in the original package to protect from lights.6.4
  • Stable at temperatures up to 25C for 72 hours, but this data is intended to guide professionals in case of a temporary temperature excursion only, not as a storage recommendation; use or discard at the end of the periods.6.4
  • Supplied as two components - a powder vial and a pre-filled syringe - reconstituted by adding the entire syringe contents to the vial and shaking until dissolveds.6.6
  • Do not pull the syringe plunger out of the barrel; if it happens, do not administer the vaccines.6.6
  • Do not administer if foreign particulate matter or abnormal appearance is seen before or after reconstitutions.6.6
  • Deep intramuscular injection, preferably alternating sites for subsequent injectionss.4.2
  • Do not administer intravascularly or intradermallys.4.4
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • The Hib capsular polysaccharide antigen is excreted in urine, so a positive urine test can be observed within 1 to 2 weeks after vaccination and other tests should be used to confirm Hib infection in that periods.4.4

Safety findings

  • The safety and efficacy of Infanrix hexa in children over 36 months 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, hepatitis B, polio or Hib vaccines.4.3
  • Contraindicated if the child had an encephalopathy of unknown cause within 7 days of a previous pertussis-containing vaccine: pertussis vaccination must be discontinued and the course continued with diphtheria, tetanus, hepatitis B, polio and Hib vacciness.4.3
  • Vaccination should be postponed during acute severe febrile illness; a minor infection is not a contraindications.4.3
  • If any of these happened after a previous pertussis-containing vaccine, further 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 dayss.4.4
  • As with any vaccine, a protective immune response may not be elicited in all vaccineess.4.4
  • The vaccine will not prevent disease caused by pathogens other than those it targetss.4.4
  • The rate of febrile reactions is higher when it is co-administered with a pneumococcal conjugate vaccine or with MMRV vaccine than when given alones.4.4, 4.5
  • Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode were observed when given with Prevenar 13s.4.4, 4.8
  • With Prevenar as a booster dose, fever of 38C or above was reported in 43.4 per cent of infants given both vaccines against 30.5 per cent given the hexavalent vaccine alone; fever above 39.5C in 2.6 per cent against 1.5 per cents.4.8
  • With MMRV co-administered, fever of 38C or above was reported in 76.6 per cent against 48 per cent with hexavalent alone; fever above 39.5C in 18 per cent against 3.3 per cents.4.8
  • Prophylactic antipyretics before or immediately after vaccination can reduce febrile reactions; data with paracetamol suggests it might reduce the fever rate while ibuprofen showed a limited effect, and prophylactic antipyretics are recommended for children with seizure disorders or a history of febrile seizuress.4.4
  • Give with caution in thrombocytopenia or bleeding disorders because bleeding may follow intramuscular injections.4.4
  • The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered in very preterm 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
  • A lower immune response has been observed in preterm infants for some antigenss.4.4
  • HIV infection is not a contraindication, but the expected immunological response may not be obtained in immunosuppressed patientss.4.4
  • In co-administration studies inconsistent antibody responses were seen, including polio type 2 with Synflorix (seroprotection ranging from 78 to 100 per cent) and pertactin with MenB and pneumococcal vaccines; the label states the 'clinical relevance of these observations remains unknown's.4.5
  • Very common reactions: loss of appetite, abnormal crying, irritability, restlessness, somnolence, fever of 38C or above, and pain, redness and local swelling at the injection sites.4.8
  • Rare reactions include anaphylactic and anaphylactoid reactions, lymphadenopathy, thrombocytopenia, collapse or shock-like state, bronchitis, apnoea, rash, angioedema and extensive swelling reactionss.4.8
  • Very rare reactions: convulsions with or without fever, and dermatitiss.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
  • Very rare reports with hepatitis B vaccine include allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, Guillain-Barre syndrome, encephalopathy, encephalitis and meningitis; the label states the causal relationship to the vaccine 'has not been established's.4.8
  • Pregnancy and lactation: the vaccine is not intended for use in adults, so adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not availables.4.6
  • Overdose: no case has been reporteds.4.9

Evidence and claims

  • After a 3-dose primary course, at least 95.7 per cent of infants developed seroprotective or seropositive antibody levels against each vaccine antigen; after the booster dose, at least 98.4 per cents.5.1
  • After a 2-dose primary course, at least 84.3 per cent; after a 2-dose course plus booster, at least 97.9 per cents.5.1
  • The Hib (anti-PRP) response after 2 doses varies with what it is given alongside: at least 84 per cent of infants overall, rising to 88 per cent with a tetanus-toxoid-carrier pneumococcal vaccine and 98 per cent with a tetanus-toxoid conjugated meningococcal vaccines.5.1
  • In a subgroup of infants who were not given hepatitis B vaccine at birth, 77.7 per cent had anti-HBs titres of 10 mIU/ml or mores.5.1
  • The measured outcomes are antibody levels above cut-offs 'accepted as indicative of protection', not observed cases of diseases.5.1
  • Preclinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity, repeated dose toxicity and compatibility of ingredientss.5.3

Document and licensing

  • Marketing authorisation holder: GlaxoSmithKline UK Limited, Londons.7
  • First authorised 1 January 2021s.9
  • Text last revised 21 March 2025s.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 ↗

After reconstitution, 1 dose (0.5 ml) contains:
 Diphtheria toxoid^1
 not less than 30 International Units (IU)
 Tetanus toxoid^1
 not less than 40 International Units (IU)
 Bordetella pertussis antigens
 Pertussis toxoid (PT)^1
 25 micrograms
 Filamentous Haemagglutinin (FHA)^1
 25 micrograms
 Pertactin (PRN)^1
 8 micrograms
 Hepatitis B surface antigen (HBs)^2,3
 10 micrograms
 Poliovirus (inactivated) (IPV)
 type 1 (Mahoney strain)^4
 40 D-antigen unit
 type 2 (MEF-1 strain)^4
 8 D-antigen unit
 type 3 (Saukett strain)^4
 32 D-antigen unit
 Haemophilus influenzae type b polysaccharide
 10 micrograms
 (polyribosylribitol phosphate, PRP)^ 3
 conjugated to tetanus toxoid as carrier protein
 approximately 25 micrograms
 ^1adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
 0.5 milligrams Al^3+
 ^2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
 ^3adsorbed on aluminium phosphate (AlPO4)
 0.32 milligrams Al^3+
 ^4propagated 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 0.057 nanograms per dose and phenylalanine 0.0298 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.
  • yeast - Used in the laboratory to produce proteins. Traces can remain, which is why a yeast allergy can be a problem.
  • recombinant - Made by genetic engineering: the gene for one piece of the germ is put into a laboratory cell or bacterium, which then makes that piece.
  • 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.

Other ingredients (excipients)

Section 6.1 source ↗

  • Hib powder:
  • Lactose anhydrousMilk sugar, used as a stabiliser and bulking agent.
  • DTPa-HBV-IPV suspension:A chelating agent, which grabs and holds trace metal ions that would otherwise break the vaccine down.
  • Sodium chloride (NaCl)Salt. 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 (25)

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. The safety and efficacy of Infanrix hexa in children over 36 months 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

  2. 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

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

  2. Infanrix hexa is contraindicated if the infant or toddlers has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.

    Section 4.3 Contraindications source ↗

    In plain English

    • contraindicated - A situation where the medicine should not be given at all.

    Not recommended, contraindicated or restricted matched: contraindicated

4.4 Special warnings and precautions for use

  1. As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. Do not administer the vaccine intravascularly or intradermally.

    Section 4.4 Special warnings and precautions for use 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

  3. A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix hexa.

    Section 4.4 Special warnings and precautions for use source ↗

    Rare or very rare serious events matched: death

  4. The use of prophylactic antipyretic medicinal products is recommended for children with seizure disorders or with a prior history of febrile seizures.

    Section 4.4 Special warnings and precautions for use source ↗

    Rare or very rare serious events matched: seizure

  5. Clinical data indicate that Infanrix hexa can be given to preterm infants, however, as expected in this population, a lower immune response has been observed for some antigens (see section 4.8 and section 5.1).

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

4.5 Interaction with other medicinal products and other forms of interaction

  1. Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.

    Section 4.5 Interaction with other medicinal products and other forms of interaction 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.

    Adjuvants, carriers and immune-stimulating ingredients matched: crm197

  2. Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co-administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if [...]

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

    In plain English

    • seroprotection - Having an antibody level above a set threshold, taken as a sign of protection.
    • antigen - The part of a germ that the immune system recognises and remembers.

    Efficacy, effectiveness and endpoints matched: immune response

  3. The clinical relevance of these observations remains unknown.

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

    Limited, insufficient or inconclusive matched: remains unknown

4.8 Undesirable effects

  1. In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, Guillain-Barré syndrome, encephalopathy, encephalitis and meningitis have been reported.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • encephalitis - Inflammation of the brain.
    • meningitis - Inflammation of the lining around the brain and spinal cord.
    • rare - In the label's frequency scale, this means it happened in up to 1 in 1,000 people studied.

    Rare or very rare serious events matched: arthritis

  2. The causal relationship to the vaccine has not been established.

    Section 4.8 Undesirable effects 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

5.1 Pharmacodynamic properties

  1. According to different studies, immune response to the PRP antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age will vary if co-administered with a tetanus toxoid conjugate vaccine.

    Section 5.1 Pharmacodynamic properties 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.
    • antigen - The part of a germ that the immune system recognises and remembers.
    • toxoid - A bacterial toxin that has been treated so it can no longer cause harm but still trains the immune system.

    Efficacy, effectiveness and endpoints matched: immune response

  2. Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  3. For pertussis there is no serological correlate of protection.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • correlate of protection - A lab measurement that is thought to predict whether someone is actually protected. It is a stand-in, not proof.

    Efficacy, effectiveness and endpoints matched: correlate of protection

  4. However, as the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix (DTPa), the protective efficacy of the two vaccines is expected to be equivalent.

    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

  5. In a follow-up of the same cohort, the efficacy was confirmed up to 60 months after completion of primary vaccination without administration of a booster dose of pertussis.

    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

  6. The persistence of the immune response to a 3-dose primary (at 2-3-4, 3-4-5 or 2-4-6 months of age) and booster (in the second year of life) schedule with Infanrix hexa was evaluated in children 4-8 years of age.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  7. * Samples tested by ELISA to have anti-diphtheria antibody concentrations < 0.1 IU/ml were re-tested using Vero-cell neutralisation assay (seroprotection cut-off ≥ 0.016 IU/ml): 96.5% of the subjects were seroprotected

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroprotection - Having an antibody level above a set threshold, taken as a sign of protection.

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

  8. The effectiveness of the Hib component of Infanrix hexa 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

  9. Over a seven-year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, 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

  1. If either is observed, 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

  2. 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 ↗