Combined 6-in-1 vaccine Pregnancy: Not applicable — SPC 4.6 verbatim: 'As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.'

Diphtheria with tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccine

Brand names: Infanrix hexa, Vaxelis

This is the hexavalent (six-in-one) vaccine combining diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b antigens, given in the UK primary infant immunisation course.

Adult dose

Dose: Infant primary immunisation with the hexavalent (6-in-1) vaccine: 0.5 ml per dose by deep intramuscular injection. The primary course is two or three doses of 0.5 ml given according to official recommendations, followed by a booster dose of 0.5 ml. SCOPE — these figures are taken from the Infanrix hexa SPC only; Vaxelis, the page's other named brand, has its own SPC which is NOT in this bundle and has not been checked. There is no adult dose: SPC 4.6 states Infanrix hexa 'is not intended for use in adults', and SPC 4.2 states safety and efficacy in children over 36 months of age have not been established.

Route: Deep intramuscular injection, preferably at alternating sites for subsequent injections. Reconstitute the powder with the suspension before administration (SPC 6.6).

Frequency: Primary course of two or three 0.5 ml doses per official recommendations — with a 3-dose primary series there should be an interval of at least 1 month between primary doses; with a 2-dose primary series, at least 2 months. A booster dose must then be given at least 6 months after the last priming dose: preferably before 18 months of age after a 3-dose primary series, or preferably between 11 and 13 months of age after a 2-dose primary series.

VERBATIM (SPC 4.2, primary vaccination): 'The primary vaccination schedule consists of two or three doses (of 0.5 ml) which should be administered according to official recommendations... The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.' || HEPATITIS B INTERPLAY (SPC 4.2), where a dose of hepatitis B vaccine is given at birth: 'Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.' 'Infanrix hexa can be used for a mixed pentavalent/hexavelent vaccine primary immunisation schedule in accordance with official recommendations. Locally established immunoprophylactic measures against hepatitis B should be maintained. Infanrix hexa can be replaced by the adminstration of a pentavalent vaccine co-adminsitered with hepatitis B vaccine.' || BOOSTER (SPC 4.2): 'After a 2-dose or a 3-dose primary series vaccination with Infanrix hexa, a booster dose with Infanrix hexa should be given at least 6 months after the last priming dose... Infanrix hexa may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTPa-IPV+Hib vaccine associated with a monovalent hepatitis B vaccine for their primary series. When a booster dose with a hexavalent DTPa (diphtheria, tetanus, and acellular pertussis) containing vaccine is not available, a dose of Hib vaccine must be administered, as a minimum.' || PRETERM (SPC 4.2 table): preterm infants born after at least 24 weeks of gestational age — 3-dose primary series, at least 1 month between primary doses, booster at least 6 months after the last priming dose and preferably before 18 months of age. || AGE LIMIT (SPC 4.2): 'The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established. No data are available.' || The SPC defers the ages to 'official recommendations'. Cross-check the UK ages against the current UKHSA Green Book schedule before relying on them. || Some sections of the product information we used were incomplete — check the full SPC. || No maxDose is entered: the SPC specifies a fixed 0.5 ml per dose and states no separate ceiling.

Paediatric dose

Dose: 0.5 ml per dose — a fixed volume for every infant. This is NOT a weight-based vaccine; do not compute a per-kilogram dose.

Route: Deep intramuscular injection, preferably at alternating sites for subsequent injections

Frequency: Two or three 0.5 ml primary doses per official recommendations (3-dose series: minimum 1 month apart; 2-dose series: minimum 2 months apart), then a booster at least 6 months after the last priming dose — preferably before 18 months of age (after a 3-dose primary) or between 11 and 13 months of age (after a 2-dose primary).

This is the vaccine's only licensed population. SPC 4.2: 'The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established. No data are available.' Preterm infants born after at least 24 weeks of gestational age follow the 3-dose primary series with a mandatory booster. The Expanded Program on Immunisation schedule (6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth. Verify the ages used in practice against the current UKHSA immunisation schedule and a children's formulary — the SPC itself defers the ages to official recommendations.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to formaldehyde, neomycin and polymyxin
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines
Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with a pertussis-containing vaccine — in these circumstances pertussis vaccination should be discontinued and the course continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines
Administration should be postponed in subjects suffering from acute severe febrile illness (the presence of a minor infection is not a contraindication)

Side effects

Very common — loss of appetite
Very common — abnormal crying, irritability, restlessness
Very common — somnolence
Very common — fever ≥ 38°C, pain, redness, local swelling at the injection site (≤ 50 mm)
Common — nervousness
Common — diarrhoea, vomiting
Common — fever > 39.5°C, injection site reactions including induration, local swelling at the injection site (> 50 mm)
Uncommon — upper respiratory tract infection
Uncommon — cough
Uncommon — diffuse swelling of the injected limb, sometimes involving the adjacent joint; fatigue
Rare — lymphadenopathy, thrombocytopenia
Rare — anaphylactic reactions, anaphylactoid reactions (including urticaria), allergic reactions (including pruritus)
Rare — collapse or shock-like state (hypotonic-hyporesponsive episode)
Rare — bronchitis, apnoea (see SPC 4.4 for apnoea in very preterm infants born at ≤ 28 weeks of gestation)
Rare — rash, angioedema
Rare — swelling of the entire injected limb, extensive swelling reactions, injection site mass, injection site vesicles
Very rare — convulsions (with or without fever)
Very rare — dermatitis
⚠️ This list is INCOMPLETE — §4.8 ends at the source-fetch limit in this bundle; content beyond the tabulated summary was never retrieved.

Clinical monograph

How it works

It presents toxoids, acellular pertussis components, hepatitis B surface antigen, inactivated poliovirus and a conjugated Hib polysaccharide to induce protective antibodies against all six targets.

Prescribing in practice

Do not give to an infant with a confirmed anaphylactic reaction to a previous dose or component, and seek advice for an evolving neurological disorder before the pertussis-containing vaccine.
It is the routine primary course given by intramuscular injection in infancy and is co-administered with other scheduled vaccines such as meningococcal, pneumococcal and rotavirus per the schedule.
Apnoea has been reported after immunisation in very premature infants, so the first dose in this group may warrant respiratory monitoring.

Monitoring

Observe for immediate hypersensitivity, monitor very preterm infants for apnoea after the first dose, and advise on expected local and febrile reactions.

Counselling the patient

Mild fever and injection-site soreness are common; paracetamol may be advised around the routine infant doses.
Seek help for a high fever or any severe reaction.
Keep all scheduled appointments to complete the primary course.

Evidence & guidelines

The hexavalent six-in-one vaccine forms the basis of the UK primary infant immunisation schedule as described in national guidance (the Green Book).

Reference: UKHSA Green Book; NHS England immunisation schedule; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways