Combined 5-in-1 vaccine
Pregnancy: Not intended for use in adults; information on the safety of the vaccine when used during pregnancy or lactation is not available.
Diphtheria with tetanus, pertussis, poliomyelitis and Hib vaccine
Brand names: Pediacel (legacy)
This is a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b (DTaP/IPV/Hib) vaccine used for primary infant immunisation against these five diseases.
Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.
Adult dose
Dose: INFANT/CHILD VACCINE - not intended for use in adults. Primary vaccination: two or three doses given in accordance with official recommendations; the minimum age at the time of the first dose is 2 months and subsequent doses of the primary course should be separated by a minimum interval of four weeks. Booster: after a two-dose primary course, a booster dose must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age; after a three-dose primary course, a booster dose of Hib conjugate vaccine (monovalent or combined) must be given, timed in accordance with official recommendations.
Route: Deep intramuscular injection into the anterolateral aspect of the thigh; it is preferable that each subsequent dose is given into alternating limbs. Must under no circumstances be administered intravascularly. Administer with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur after intramuscular administration - apply firm pressure to the injection site without rubbing for at least two minutes. Requires reconstitution before administration (see section 6.6 of the SPC).
Frequency: Two or three primary doses at least four weeks apart from 2 months of age, followed by a booster as above
Max: No maximum dose is stated; the number of doses is set by the official immunisation schedule
Source: eMC SPC for Infanrix-IPV+Hib, powder and suspension for suspension for injection (https://www.medicines.org.uk/emc/product/5301/smpc), section 4.2. PRODUCT NOTE: this page names Pediacel (legacy) as its brand, whereas the SPC fetched is Infanrix-IPV+Hib - a different manufacturer's 5-in-1 vaccine covering the same five antigen groups (diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, Hib). The schedule above is Infanrix-IPV+Hib's; confirm it against the SPC of the specific product in hand and against the UKHSA Green Book before publishing. VOLUME NOT STATED: the fetched section 4.2 gives no volume per dose - take the injection volume from section 6.6 of the SPC (this page currently carries 0.5 mL, which is NOT in the fetched text). This product may be used as a booster for children previously immunised with other vaccines containing DTP, polio and Hib antigens, and may be used for the post-three-dose Hib booster if giving the additional antigens at the same time is in accordance with official recommendations. Safety and efficacy in children over 3 years of age have not been established (no data). Consider the potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours when giving the primary immunisation series to very premature infants (born at or before 28 weeks of gestation), particularly those with a previous history of respiratory immaturity - vaccination should not be withheld or delayed as the benefit is high in this group. Excretion of capsular polysaccharide antigen in urine can cause false-positive Hib antigen detection results within 1 to 2 weeks of vaccination. The Hib component does not protect against disease due to other types of Haemophilus influenzae or against meningitis caused by other organisms.
Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.
Contraindications
- Hypersensitivity to the active substances or to any of the excipients, or to formaldehyde, neomycin or polymyxin
- Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio or Hib vaccines
- Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with a pertussis-containing vaccine
- Postpone in subjects suffering from an acute severe febrile illness (a minor infection is not a contraindication)
Side effects
- Very common: fever (38.0 degrees C or above), injection site pain and redness, local swelling at the injection site up to 50 mm
- Very common: appetite lost, abnormal crying, irritability, restlessness, somnolence
- Common: diarrhoea, vomiting; injection site induration and local swelling greater than 50 mm; fever above 39.5 degrees C is common with booster vaccination
- Uncommon: diffuse swelling of the injected limb sometimes involving the adjacent joint, fatigue, lymphadenopathy, upper respiratory tract infection, bronchitis, cough, rhinorrhoea, urticaria, rash
- Post-marketing: allergic reactions including anaphylactic and anaphylactoid reactions, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions with or without fever, apnoea, angioneurotic oedema, swelling of the entire injected limb, injection site vesicles
Interactions
- Immunosuppressive therapy - the expected immunological response may not be obtained after vaccination of immunosuppressed patients
- NOTE: eMC section 4.5 was not captured in this bundle and no US label was fetched; check the SPC for co-administration advice with other childhood vaccines
Clinical monograph
How it works
Diphtheria and tetanus toxoids, acellular pertussis components, inactivated poliovirus and a conjugated Hib polysaccharide together stimulate protective antibody responses.
Prescribing in practice
- Defer in any infant with anaphylaxis to a previous dose or component and obtain specialist advice for an unstable neurological condition before pertussis-containing vaccine.
- Give by intramuscular injection as part of the primary course; apnoea has been reported in very premature infants after immunisation and may require monitoring of the first dose.
- Postpone for acute febrile illness but proceed despite minor intercurrent infection.
Monitoring
Observe for immediate allergic reactions, watch very preterm infants for apnoea after the first dose, and advise on common transient reactions.
Counselling the patient
- Mild fever and a sore leg or arm are expected and settle quickly.
- Report any high fever or severe reaction promptly.
- Attend all appointments so the schedule is completed on time.
Evidence & guidelines
DTaP/IPV/Hib combinations are used for primary childhood immunisation within the UK schedule as set out in national guidance (the Green Book).
Reference: UKHSA Green Book; 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).
Related
Curated clinical cross-links plus same-class fallbacks.