InsertFile

All vaccines

Adacel (Tdap)

ADACEL, suspension for injection in pre-filled syringe.

Manufacturer
SANOFI
Label last updated
01 Jun 2026
Source
Official SmPC ↗

The teenage booster for tetanus, diphtheria and whooping cough, from 4 years of age. Also given in pregnancy to protect newborns from whooping cough. Not for primary immunisation.

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

Ingredients and materials

  • Diphtheria toxoid not less than 2 IU (2 Lf) and tetanus toxoid not less than 20 IU (5 Lf) per 0.5 ml doses.2
  • Four whooping cough antigens at lower doses than the infant vaccine: pertussis toxoid 2.5 micrograms, filamentous haemagglutinin 5 micrograms, pertactin 3 micrograms, fimbriae types 2 and 3 5 microgramss.2
  • Adsorbed on aluminium phosphate, 1.5 mg (0.33 mg Al3+), present as an adjuvants.2
  • May contain traces of formaldehyde and glutaraldehyde used during manufacture; hypersensitivity to residual substances carried over from manufacture is a contraindication, even where they may be present in undetectable trace amountss.2, 4.3
  • Excipients: phenoxyethanol (a preservative), water for injectionss.6.1
  • The soft tip caps of the 1.5 ml pre-filled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individualss.4.4

Manufacture, storage and handling

  • Shelf life 4 yearss.6.3
  • Store at 2C to 8C, do not freeze, discard if it has been frozen, keep the syringe in the outer carton to protect from lights.6.4
  • Stable at temperatures up to 25C for 72 hours, but these data are intended to guide professionals in case of a temporary temperature excursion only; use or discard at the end of the periods.6.4
  • Normal appearance is a uniform cloudy white suspension that may sediment and form clumpy or flaky aggregates; shake well, and if aggregates are present it can be shaken again until uniforms.6.6
  • Discard the syringe if there is foreign particulate matter, leakage, premature activation of the plunger or a faulty tip seal; single use only and must not be reuseds.6.6
  • Intramuscular injection, preferably into the deltoid; must not be given into the gluteal area, and intradermal or subcutaneous routes should not be useds.4.2
  • Must not be administered by intravascular or intradermal injections.4.4
  • Needles should not be recappeds.6.6
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • A single 0.5 ml dose in all indicated age groups; it cannot be used for primary immunisations.4.1, 4.2, 4.4

Safety findings

  • Licensed as a booster from 4 years of age following primary immunisation, and to give passive protection against whooping cough in early infancy following maternal immunisation in pregnancys.4.1
  • 'ADACEL should not be used for primary immunization's.4.4
  • Contraindicated in known hypersensitivity to diphtheria, tetanus or pertussis vaccines, to any other component, or to residual formaldehyde and glutaraldehydes.4.3
  • Contraindicated in anyone who had an encephalopathy of unknown origin within 7 days of a previous pertussis-containing vaccines.4.3
  • Should not be given to people with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabiliseds.4.4
  • If Guillain-Barre syndrome occurred within 6 weeks of a previous tetanus toxoid vaccine, the decision to give any tetanus toxoid vaccine including ADACEL must weigh potential benefits against possible riskss.4.4
  • In people with a history of a serious or severe reaction within 48 hours of a previous injection with similar components, administration must be carefully considereds.4.4
  • Immunogenicity could be reduced by immunosuppressive treatment or immunodeficiency; vaccination should be postponed until the end of such disease or treatment if practical, though vaccination of HIV infected people or those with chronic immunodeficiency is recommended even if the antibody response might be limiteds.4.4
  • Intramuscular injections should be given with care to patients on anticoagulant therapy or with coagulation disorders because of the risk of haemorrhage; deep subcutaneous administration may be considered, although there is a risk of increased local reactionss.4.4
  • Fainting can occur after or even before administration, so procedures should be in place to prevent falling injurys.4.4
  • A persistent nodule at the injection site may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissues.4.4
  • As with any vaccine, it may not protect 100 per cent of susceptible individualss.4.4
  • Antibody response one month after vaccination varies by age group: for diphtheria, 100 per cent of children, 99.8 per cent of adolescents and 94.1 per cent of adults reached the threshold; pertussis booster responses in adults were lower, for example 82.7 per cent for filamentous haemagglutinin and 85.9 per cent for fimbriaes.5.1
  • 'Serological correlates for protection against pertussis have not been established'; the label instead compares antibody levels with those seen in an infant efficacy trial where protective efficacy against pertussis disease was 85 per cent, and considers that ADACEL had elicited protective immune responsess.5.1
  • In clinical trials ADACEL was given to 4,546 people: 298 children aged 4 to 6, 1,313 adolescents aged 11 to 17 and 2,935 adults aged 18 to 64s.4.8
  • Local reactions at the injection site occurred in 21 to 78 per cent of vaccinees, and headache and tiredness in 16 to 44 per cent, usually mild and within 48 hours, resolving without sequelaes.4.8
  • When given together with HPV and meningococcal ACWY vaccines, injection site reactions, headache, malaise and myalgia were observed more frequently than when given alone; the differences in headache, malaise and myalgia ranged from less than 10 per cent to less than 28 per cents.4.8
  • Large injection site reactions over 50 mm, including extensive limb swelling beyond one or both joints, occur in adolescents and adults; they start within 24 to 72 hours, may be associated with redness, warmth, tenderness or pain, and resolve spontaneously within 3 to 5 dayss.4.8
  • Post-marketing reports at frequency not known include hypersensitivity and anaphylactic reactions with angioedema, oedema, rash and hypotension, paraesthesia, hypoaesthesia, Guillain-Barre syndrome, brachial neuritis, facial palsy, convulsions, syncope, myelitis, myocarditis, pruritus, urticaria, myositis, injection site bruising, injection site sterile abscess and injection site nodules.4.8
  • Because post-marketing events are reported voluntarily from a population of uncertain size, frequency cannot be reliably estimated and a causal relationship cannot always be establisheds.4.8
  • Pregnancy: may be used in the second or third trimester. Safety data come from 4 randomised controlled trials with 310 pregnancy outcomes, 1 prospective observational study with 546 outcomes, 5 retrospective observational studies with 124,810 outcomes, and passive surveillance, which showed no vaccine-related adverse effect on pregnancy or on the health of the fetus or newborns.4.6
  • Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal or fetal development, parturition or postnatal developments.4.6
  • Breastfeeding: it is not known whether the active substances are excreted in human milk, but antibodies to the vaccine antigens have been found to transfer to the suckling offspring of rabbits, with no harmful effects seen. The effect on breast-fed infants of giving the vaccine to their mothers has not been studied, but as ADACEL is inactivated any risk is unlikelys.4.6
  • Fertility: ADACEL has not been evaluated in fertility studiess.4.6
  • Overdose: not applicables.4.9

Evidence and claims

  • Antibody persistence was followed at 3, 5 and 10 years in people who had received a single booster dose; ADACEL can be used for repeat vaccination at 5 to 10 year intervalss.4.2, 5.1
  • The pertussis antibody levels after a booster in adolescents and adults exceeded those observed in a household contact study nested within the Sweden I efficacy trial, which is the basis for calling the response protective in the absence of an established correlates.5.1
  • Immune responses in adults and adolescents were comparable to a single dose of an adult diphtheria-tetanus vaccine containing the same amounts of tetanus and diphtheria toxoidss.5.1
  • Clinical data showed no clinically relevant difference in adverse reaction rates when a tetanus, diphtheria and pertussis booster was given as early as 4 weeks rather than at least 5 years after a preceding tetanus and diphtheria doses.4.4
  • In children who had previously received 4 doses including primary immunisation, the most common adverse events within 14 days were pain at the injection site in 39.6 per cent and tiredness in 31.5 per cents.4.8
  • Preclinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity in pregnancy, embryonal and fetal development, parturition and postnatal developments.5.3

Document and licensing

  • Marketing authorisation holder: Sanofi Winthrop Industrie, France; distributed by Sanofi in the UKs.7
  • Date of authorisation 4 April 2016, renewal 4 April 2021s.9
  • Text last revised 14 May 2026s.10
  • The pregnancy dataset is large - over 124,000 outcomes from retrospective observational studies - which is unusual for a vaccine label and is stated explicitlys.4.6
  • 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 ↗

1 dose (0.5 mL) contains:
 Diphtheria Toxoid
 Not less than 2 IU* (2 Lf)
 Tetanus Toxoid 
 Not less than 20 IU* (5 Lf)
 Pertussis Antigens
  Pertussis Toxoid 
 2.5 micrograms 
  Filamentous Haemagglutinin
 5 micrograms
  Pertactin
 3 micrograms
  Fimbriae Types 2 and 3
 5 micrograms
 Adsorbed on aluminium phosphate ^ 
 1.5 mg (0.33 mg Al^3+)
 * As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
 This vaccine may contain traces of formaldehyde and glutaraldehyde which are used during the manufacturing process (see sections 4.3 and 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.
  • formaldehyde - A chemical used to inactivate (kill) viruses or bacteria during manufacture. It is then removed, and only trace amounts can remain.

Other ingredients (excipients)

Section 6.1 source ↗

  • Phenoxyethanol2-phenoxyethanol, a preservative that stops bacteria growing in a multi-dose container. Also used in cosmetics.
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
Audit trail: every flagged sentence in the document (27)

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. ADACEL should not be administered into the gluteal area; intradermal or subcutaneous routes should not be used (in exceptional cases the subcutaneous route may be considered, see section 4.4).

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • should not be used - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be used

4.3 Contraindications

  1. ADACEL should not be administered to person with known hypersensitivity  - to diphtheria, tetanus or pertussis vaccines  - to any other component of the vaccine (see section 6.1)  - to any residual substances carried over from manufacture (formaldehyde and glutaraldehyde), which may be present in undetectable trace amounts.

    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

  1. ADACEL should not be used for primary immunization.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • should not be used - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be used

  2. If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including ADACEL should be based on careful consideration of the potential benefits and possible risks.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • toxoid - A bacterial toxin that has been treated so it can no longer cause harm but still trains the immune system.

    Rare or very rare serious events matched: guillain

  3. Do not administer by intravascular or intradermal injection.

    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

4.6 Fertility, pregnancy and lactation

  1. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.

    Section 4.6 Fertility, pregnancy and lactation source ↗

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

  2. For information on immune responses to vaccination during pregnancy and its effectiveness at preventing pertussis in infants, see section 5.1.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

  3. It is not known whether the active substances included in ADACEL are excreted in human milk but antibodies to the vaccine antigens have been found to be transferred to the suckling offspring of rabbits.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  4. However, the effect on breast-fed infants of the administration of ADACEL to their mothers has not been studied.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.

    No data / not studied matched: has not been studied

  5. ADACEL has not been evaluated in fertility studies.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.

    No data / not studied matched: has not been evaluated

4.8 Undesirable effects

  1. Because post-marketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

    Section 4.8 Undesirable effects 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.
    • uncertain - The evidence does not settle the question.

    Limited, insufficient or inconclusive matched: uncertain

  2. Therefore, the frequency category “Not known” is assigned to these adverse events.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  3. Paraesthesia*, Hypoaesthesia*, Guillain-Barré Syndrome*, Brachial Neuritis*, Facial Palsy*, Convulsions*, Syncope*, Myelitis*

    Section 4.8 Undesirable effects source ↗

    Rare or very rare serious events matched: brachial

5.1 Pharmacodynamic properties

  1. Immune response of children, adolescents and adults one month after vaccination with ADACEL

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. Serological correlates for protection against pertussis have not been established.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • not been established - There is not yet enough evidence to state a conclusion.

    No data / not studied matched: have not been established

  3. On comparison with data from the Sweden I pertussis efficacy trials conducted between 1992 and 1996, where primary immunization with Sanofi Pasteur _acellular pertussis infant DTaP formulation confirmed a protective efficacy of 85% against pertussis disease, it is considered that ADACEL had elicited protective immune responses.

    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

  4. The pertussis antibody levels for all antigens following a booster dose of ADACEL in adolescents and adults exceeded those observed in a household contact study nested within the efficacy trial.

    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. Ratio of pertussis antibody GMC observed one month after a dose of ADACEL in adolescents and adults compared with those observed in infants one month following vaccination at 2, 4 and 6 months of age in the Sweden I efficacy trial with DTaP (PPI Population^1)

    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. ^3 N = 80, number of infants who received DTaP at 2, 4 and 6 months of age with available data post-dose 3 (sera from the Sweden I Efficacy Trial tested contemporaneously with samples from study Td506).

    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

  7. ^4 GMCs following COVAXiS were non-inferior to GMCs following DTaP (lower limit of 95% CI on the ratio of GMCs for COVAXiS divided by DTaP >0.67).

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: non-inferior

  8. The geometric mean concentrations (GMC) in EU/mL for the anti-pertussis antibodies to the PT, FHA, PRN, and FIM antigens in infants of vaccinated women were, respectively, 68.8, 234.2, 226.8, and 1867.0 at birth, and 20.6, 99.1, 75.7, and 510.4 at 2 months of age.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  9. These higher antibody concentrations should provide passive immunity against pertussis for the infant during the first 2 to 3 months of life, as has been shown by observational effectiveness studies.

    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

  10. Maternal antibodies derived after ADACEL or REPEVAX vaccination in pregnancy may be associated with blunting of the infant immune response to active immunization against pertussis.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  11. Effectiveness against pertussis in infants born to women vaccinated during pregnancy The vaccine effectiveness in the first 2-3 months of life for infants born to women vaccinated against pertussis during the third trimester of pregnancy has been evaluated in 3 observational studies.

    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

  12. The overall effectiveness is > 90%.

    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

  13. Vaccine effectiveness (VE) against pertussis disease in young infants born to mothers vaccinated during pregnancy with ADACEL or REPEVAX in 3 retrospective studies.

    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

5.3 Preclinical safety data

  1. Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity in pregnancy, embryonal/fetal development, parturition and postnatal development.

    Section 5.3 Preclinical safety data source ↗

    In plain English

    • non-clinical - Lab and animal studies, done before or alongside human trials.

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

Read the whole document at the source ↗