This website contains promotional content and is intended for Healthcare Professionals

Home
Products
Adacel®

Adacel®

What is ADACEL®?

ADACEL® (Tdap) is a 3-in-1 booster vaccine that helps protect against diphtheria, tetanus and pertussis.

ADACEL® is a 3-in-1 booster vaccine which can prevent 3 major diseases in one simple injection.

What is the Composition of ADACEL®?

One ADACEL® dose (0.5 mL) contains:

What is the Formulation of ADACEL®?

ADACEL® is a suspension for injection, with a cloudy white appearance.

ADACEL® is a ‘ready to use’ vaccine, with no reconstitution required.

Clinical information for ADACEL®

What is ADACEL® indicated for?

ADACEL® is a booster vaccine that can be used from 4 years of age following primary immunization, for:

repeat vaccination to boost immunity to diphtheria, tetanus and pertussis (whooping cough) at 5- to 10-year intervals,

passive protection against pertussis during early infancy following maternal immunization ideally during third trimester of pregnancy.

ADACEL® is the first Tdap vaccine indicated for use during pregnancy for protection against pertussis in newborns and infants too young to commence primary immunizations.

ADACEL® can be used in individuals with an incomplete, or no history of previous pertussis vaccination.

However, a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection.

ADACEL® can be administered when the opportunity presents itself, regardless of pertussis vaccination history.

 The use of ADACEL® should be in accordance with official recommendations.

What is the schedule of administration for ADACEL®?

ADACEL®  is indicated for a broad population – helping to protect school-aged children, adolescents, adults and seniors against potentially life-threatening diseases. Through vaccination during pregnancy ADACEL®  also helps protect newborns against pertussis until they start their primary vaccinations.

Td, tetanus-diphtheria; Tdap, tetanus-diphtheria-acellular pertussis.

How is ADACEL® administered?

ADACEL® must be administered via intramuscular injection. The preferred site is into the deltoid muscle.

  • Do not administer into the gluteal area.
  • Do not administer by intravascular or intradermal injection.

What are the contraindications of ADACEL®?

ADACEL® must not be used in the following scenarios:

What are the special warnings and precautions for use with ADACEL®?

ADACEL® should not be used for primary immunization.

What interval is required between ADACEL® and prior vaccines?
Follow the official recommendations when determining the interval between a booster dose of ADACEL® and preceding booster doses of diphtheria- and/or tetanus-containing vaccines.
Clinical data have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of a tetanus-, diphtheria- and pertussis-containing booster vaccine as early as 4 weeks, compared to at least 5 years, after a preceding dose of tetanus and diphtheria-containing vaccine.

Carefully consider risks/benefits of vaccination in cases of:

  • Development of Guillain-Barré syndrome after previous tetanus toxoid-containing vaccine
  • Previous serious or severe reaction within 48 hours of a vaccine containing similar components

 ADACEL® should not be administered to persons with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.

Carefully consider the following scenarios when administering ADACEL®:

Immunodeficiency
The immunogenicity of ADACEL® may be reduced by immunosuppressive treatment or immunodeficiency. It is recommended to postpone vaccination until the end of such treatment or disease. Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.

Bleeding disorders
ADACEL® must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration. In these situations, administration of ADACEL®by deep subcutaneous injection may be considered.

Does ADACEL® interact with other medicinal products?

ADACEL® is an inactivated vaccine and may be administered concomitantly with other vaccines and immunoglobins.
If co-administration with another vaccine is required, immunization should be carried out at separate injection sites.

ADACEL® provides the flexibility to vaccinate when the opportunity presents itself.
Concomitant administration of ADACEL® with MCV4* - FLU - Hep.B - OPV/IPV - HPV* vaccines was generally well-tolerated and did not interfere with the immune response to the respective vaccines.

What safety information is there for ADACEL® in pregnancy?

 

Pregnancy
Clinical data from >80,000 pregnancies where ADACEL® or ADACEL® POLIO was administered during the 3rd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child.

Pre-existing maternal antibodies can influence antibody responses in infants (blunting):

Limited clinical data have shown there is interference with the immune response to other antigens (i.e. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with ADACEL® or ADACEL® POLIO during pregnancy. However, in most cases, the antibody concentrations remain above the thresholds established as protective. The clinical relevance of this observation is unknown.

Maternal antibodies directed against pertussis antigens persist for 2 to 4 months after birth and may be associated with blunting of the infant immune response to active immunization against pertussis (see section 4.4 of the ADACEL® SmPC for further information).

Lactation
As ADACEL® is inactivated, any risk to the infant is unlikely. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.

ADACEL® provides the reassurance of using a well-tolerated vaccine with a strong safety profile, even in special populations like pregnant women.

Can ADACEL® affect the ability to drive and use machinery?

ADACEL® has no or negligible influence on the ability to drive and use machines.

What are the possible undesirable effects of ADACEL®?

In clinical studies of individuals who received ADACEL®, the most frequently reported adverse reactions include:

Injection-site reaction 
(pain, swelling and redness)

Headache

Tiredness

These signs and symptoms were usually mild in intensity and occurred within 48 hours following vaccination.

Pharmacological properties of ADACEL®

ADACEL® induces a highly immunogenic and seroprotective response against the antigens it contains, regardless of immunization schedule.

Immune response in children, adolescents and adults one month after vaccination with ADACEL®

 Children
(4–6 yrs, n=265)		Adolescents
(11–17 yrs, n=527)		Adults
(18–64 yrs, n=743)
Diphtheria toxoid*100.0%99.8%94.1%
Tetanus toxoid*100.0%100.0%100.0%
Pertussis toxoid†91.9%92.0%84.4%
Filamentous haemagglutinin†88.1%85.6%82.7%
Pertactin†94.6%94.5%93.8%
Fimbriae Types 2 and 3†94.3%94.9%85.9%85.9%

*Immune response defined as ≥0.1 IU/mL.
†Booster response: for children 4-6 years of age previously primed with DTaP (diphtheria toxoid [paediatric dose], tetanus and acellular pertussis) at 2, 4, 6 and 18 months of age, a booster response is defined as a 4-fold increase in concentration of anti-pertussis antibodies. For adolescents and adults, a booster response is defined as a 2-fold increase in concentration of anti-pertussis antibodies in participants with high pre-vaccination concentration and a 4-fold increase in participants with low pre-vaccination concentration.

ADACEL®  use in pregnant women provides strong protection against pertussis disease for infants too young to be vaccinated.

Vaccine effectiveness (VE) against pertussis disease in young infants born to mothers vaccinated during pregnancy with Tdap (ADACEL®) or Tdap-IPV (ADACEL-POLIO®).

*Over 80% of Tdap used in study.
Three retrospective studies: REPEVAX® data from the UK (unmatched case-control and screening [case-coverage] studies), ADACEL® data from the US (cohort regression model).

Tdap, tetanus-diphtheria-acellular pertussis; Tdap-IPV, tetanus-diphtheria-acellular pertussis-inactivated polio.

Practical considerations for ADACEL®

What excipients does ADACEL® contain?

  • Phenoxyethanol
  • Water for injections

Can ADACEL® be mixed with other products?

In the absence of compatibility studies, ADACEL® must not be mixed with other medicinal products.

What is the shelf life of ADACEL®?

ADACEL® has a shelf life of 3 years.

Always check the expiry date before administering.

How do I store ADACEL®?

Store ADACEL® in a refrigerator (2°C–8°C) in its outer carton.

What ADACEL® presentations are available?

ADACEL® is available as a vial, containing 0.5 mL suspension for injection:

ADACEL® Vial
Pack sizes of 1

How do I prepare ADACEL® for administration?

  • Shake well to obtain a homogeneous, whitish, cloudy suspension.
  • Visual inspection – In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the pre-filled syringe.
  • Cleanse the vial stopper prior to withdrawing the dose.
  • Use a separate sterile needle and syringe.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing information

Sanofi Pasteur Limited, Toronto, Canada

How long has  ADACEL® been approved?

Globally ADACEL was approved since 1999

→ Adacel API

MAT-BH-2400013-v1-Jan 24