Combined vaccine (Td/IPV)
Pregnancy: Avoid in pregnancy unless boosting immunity is considered urgent. §4.6 verbatim: 'The effect of REVAXIS on embryo-foetal development has not been assessed in animals. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. However, this vaccine should not be administered to pregnant women unless it is considered urgent to boost immunity.' Breastfeeding, verbatim: 'REVAXIS may be administered to breastfeeding women.' Fertility, verbatim: 'No fertility studies were performed.'
Diphtheria with tetanus and poliomyelitis vaccine
Brand names: Revaxis
This is a combined diphtheria, tetanus and inactivated poliomyelitis (Td/IPV) vaccine, used in the UK childhood and adolescent programme as the pre-school or teenage booster and for primary immunisation in older individuals.
Adult dose
Dose: Booster immunisation against diphtheria, tetanus and poliomyelitis (reduced-dose diphtheria toxoid, Td/IPV) — 0.5 ml per dose, in children from the age of six years, adolescents and adults. §4.2 verbatim: 'The dose for children from the age of six years, adolescents and adults is 0.5 ml.' The volume is fixed: it is identical for children from six years, adolescents and adults, and is not scaled by age or weight. SCOPE: this entry is sourced from the SPC for REVAXIS, which is this page's only named brand and whose composition matches this page's category exactly — §4.2 describes it as a vaccine 'that provide[s] reduced dose diphtheria toxoid plus tetanus toxoid in combination with inactivated poliomyelitis viruses'. AGE FLOOR — IMPORTANT ON A PAEDIATRICS PAGE: this SPC states a dose only from six years of age; it gives no dose for children under six years, who require a different product. INDICATION SCOPE (§4.2 verbatim): 'REVAXIS may be used as a booster following primary immunisation with inactivated or oral poliomyelitis vaccines (IPV or OPV).' PRIMARY COURSE NOT COVERED (§4.2 verbatim): 'There are no clinical data available regarding the use of REVAXIS in individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids or of vaccinations against poliomyelitis.' TETANUS-PRONE INJURY (§4.2 verbatim): 'Although REVAXIS has not been studied in subjects with tetanus-prone injuries, studies have shown that it induces similar tetanus antitoxin titres to Td vaccine. REVAXIS may therefore be used in subjects with tetanus-prone injuries if concomitant vaccination against diphtheria and poliomyelitis is desirable.'
Route: Intramuscular injection only, into the deltoid region. §4.2 verbatim: 'REVAXIS is for intramuscular injection only. The recommended injection site is the deltoid region. REVAXIS must not be administered by intradermal or intravascular routes. Under certain conditions (e.g. bleeding disorders) REVAXIS may be administered as a deep subcutaneous injection.' §4.4 repeats the absolute route restriction: 'REVAXIS should under no circumstances be administered intravascularly. The intradermal route must not be used either.'
Frequency: A single 0.5 ml dose per administration. This SPC deliberately does NOT set a schedule — it defers to national policy. §4.2 verbatim: 'REVAXIS should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that provide reduced dose diphtheria toxoid plus tetanus toxoid in combination with inactivated poliomyelitis viruses.' MINIMUM INTERVAL FROM A PREVIOUS DIPHTHERIA- OR TETANUS-CONTAINING DOSE (§4.4 verbatim): 'In order to minimise the risk of adverse events, REVAXIS should not be administered to subjects who completed a primary vaccination course or received a booster of a vaccine containing diphtheria or tetanus toxoids within the previous five years.' The number of doses and the intervals between them must be taken from the current UK immunisation schedule, not from this label.
Max: A single 0.5 ml dose per administration. This SPC states no dose larger than 0.5 ml, no weight-adjusted or age-adjusted volume, and no multiple-dose administration at one visit.
The recovered UK SPC is for REVAXIS suspension for injection in pre-filled syringe (eMC product 5581) — the single brand this page names, with the composition the page's category states (Td/IPV: reduced-dose diphtheria toxoid, tetanus toxoid and inactivated poliomyelitis viruses). Route (intramuscular), indication (booster immunisation against diphtheria, tetanus and poliomyelitis) and dose form all match. §4.2 was retrieved COMPLETE — it ends at the cross-reference to section 6.6 with no truncation marker — so the posology above is the whole posology. §4.3 and §4.4/§4.5 and §4.6 were also retrieved complete; only §4.8 was cut at the source-fetch limit, and there only part-way through the Yellow Card reporting boilerplate after the adverse-reaction table, so the reaction list below is substantively complete but is labelled as capture-limited. This SPC expressly defers the schedule to 'official recommendations and/or local practice'. EXCIPIENT DECLARATIONS (§4.4 verbatim): 'REVAXIS contains 10 microgram phenylalanine in each 0.5 ml dose which is equivalent to 0.17 microgram/kg for a 60 kg person. Phenylalanine may be harmful for people with phenylketonuria (PKU)'; 'REVAXIS contains 2 milligram of alcohol (ethanol) in each 0.5ml dose. The small amount of alcohol in this medicine will not have any noticeable effects'; 'REVAXIS contains less than 1mmol of potassium (39 mg) and sodium (23 mg) per dose, that is to say essentially potassium-free and sodium-free.'
Paediatric dose
Route: Intramuscular injection only, into the deltoid region; never intradermally or intravascularly. Deep subcutaneous injection may be used under certain conditions (e.g. bleeding disorders).
Frequency: A single 0.5 ml dose per administration, from six years of age, given in accordance with official immunisation recommendations
FIXED VOLUME DOSE, NOT WEIGHT-BASED — dosePerKg is deliberately null because this SPC expresses the paediatric dose as a fixed 0.5 ml volume, identical to the adult dose, not as a per-kilogram figure. Do not derive a per-kg value. VERBATIM (§4.2): 'The dose for children from the age of six years, adolescents and adults is 0.5 ml.' UNDER SIX YEARS: this SPC gives NO dose below six years of age — it states a dose only 'for children from the age of six years' — so it cannot be used to vaccinate younger children, who require a different diphtheria/tetanus/polio-containing product with its own SPC. PRIMARY COURSE: §4.2 states 'There are no clinical data available regarding the use of REVAXIS in individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids or of vaccinations against poliomyelitis', so this product is a booster, not a primary immunisation course. MINIMUM INTERVAL (§4.4): must not be given to a child who completed a primary vaccination course or received a booster of a diphtheria- or tetanus-toxoid-containing vaccine within the previous five years. Verify every under-18 immunisation against the current official UK immunisation recommendations and a children's formulary, and against the SPC of the specific product being given.
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 diphtheria, tetanus or poliomyelitis vaccines, or to any of the excipients listed in section 6.1
- Hypersensitivity to neomycin, streptomycin or polymyxin B — these are used during production and traces may remain in the vaccine
- Acute severe febrile illness (the presence of a minor infection is not a contraindication)
- Neurological complications following an earlier immunisation against diphtheria and/or tetanus
- Must never be administered by the intradermal or intravascular route (§4.2, §4.4)
- Must not be given to a subject who completed a primary vaccination course, or received a booster, of a diphtheria- or tetanus-toxoid-containing vaccine within the previous five years (§4.4)
Side effects
- Very common — local injection site reactions: injection site pain, erythema, induration, oedema and injection site nodule. In clinical studies these were reported by 65 to 80% of subjects in each trial, usually with onset within the 48 hours following vaccination and persisting for 1 to 2 days
- Common — headache; vertigo; nausea/vomiting; pyrexia
- Uncommon — lymphadenopathy; myalgia; malaise
- Rare — arthralgia
- Not known — systemic allergic/anaphylactic reactions including shock; convulsions; Guillain-Barre syndrome; brachial neuritis; transient paraesthesia and hypoaesthesia of the vaccinated limb; vasovagal syncope
- Not known — abdominal pain; diarrhoea
- Not known — allergic-type reactions such as urticaria, various types of rash and face oedema; pain in the vaccinated limb
- Not known — large injection site reaction (greater than 50 mm), including extensive limb swelling from the injection site beyond one or both joints; these start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site, and resolve spontaneously within 3-5 days
- Not known — pallor and asthenia, usually occurring and resolving within a few days; chills; influenza-like symptoms, mostly the same day as the vaccination
- NOTE: §4.8 was cut off at the source-fetch limit part-way through the Yellow Card reporting boilerplate that follows the adverse-reaction table. The tabulated reactions above were captured in full, but treat the list as capture-limited and consult the SPC.
Monitoring
- Have appropriate medical treatment readily available for immediate use in case of an anaphylactic reaction following vaccination, as for all vaccines (§4.4)
- Confirm the interval since the last diphtheria- or tetanus-toxoid-containing vaccine: do not give if a primary course was completed, or a booster received, within the previous five years (§4.4)
- Administer with caution in subjects with thrombocytopenia or a bleeding disorder, since bleeding may occur following intramuscular administration; deep subcutaneous injection may be used instead in such subjects (§4.2, §4.4)
- Have procedures in place to prevent falling and injury and to manage syncope, which can occur following — or even before — any vaccination as a psychogenic response to the needle injection (§4.4)
- Where Guillain-Barre syndrome or brachial neuritis has followed a previous tetanus-toxoid-containing vaccine, base the decision to give any further tetanus-toxoid-containing vaccine on careful consideration of the potential benefits and possible risks (§4.4)
- In immunosuppressed subjects the immunogenicity may be reduced; where possible postpone vaccination until immune function has recovered, but vaccination of subjects with chronic immunodeficiency such as AIDS is recommended even if the antibody response might be limited (§4.4)
- Subjects taking immunosuppressive agents may not respond to the vaccine (§4.5)
- Record the name and batch number of the administered product to support traceability of biological medicinal products (§4.4)
- Excipients: contains 10 microgram phenylalanine per 0.5 ml dose, which may be harmful in phenylketonuria; contains 2 milligram of alcohol (ethanol) per 0.5 ml dose; essentially potassium-free and sodium-free (§4.4)
- May be given at the same time as other vaccines or immunoglobulins provided the injections are made at separate sites (§4.5)
Clinical monograph
How it works
It contains diphtheria and tetanus toxoids with inactivated poliovirus antigens that stimulate protective antibody responses without causing the diseases.
Prescribing in practice
- Defer in anyone with a confirmed anaphylactic reaction to a previous dose or a vaccine component, and postpone routinely if the child is acutely unwell with fever.
- Give by intramuscular injection and never administer the lower-antigen Td/IPV preparation where a higher-antigen primary schedule is specifically indicated for the child's age.
- Record the dose and schedule position; minor illness without fever is not a reason to delay.
Monitoring
Observe briefly after vaccination for immediate hypersensitivity and advise on expected local reactions such as soreness, redness and swelling.
Counselling the patient
- Mild fever and a sore arm are common and settle within a day or two.
- Seek advice if a severe or unusual reaction occurs.
- Keep the child's immunisation record up to date.
Evidence & guidelines
The Td/IPV vaccine is used as the adolescent booster in the UK routine immunisation schedule as set out 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).
Related
Curated clinical cross-links plus same-class fallbacks.
