Tetanus toxoid, diphtheria toxoid, purified Bordetella pertussis antigens: Recombinant pertussis toxin (rPT), filamentous haemagglutinin (FHA).
Each single dose (0.5 mL) contains Tetanus Toxoid 7.5 Lf, Diphtheria Toxoid 2.0 Lf, Purified Bordetella pertussis antigens: Recombinant Pertussis Toxin (PTgen) 5 μg, Filamentous Haemagglutinin (FHA) 5 μg.
Boostagen is a combined tetanus toxoid, reduced diphtheria toxoid and recombinant pertussis vaccine (TdaP or TdaPgen). Boostagen is a sterile, whitish, turbid and uniform suspension. This vaccine contains purified tetanus toxoid, diphtheria toxoid and purified Bordetella pertussis antigens (recombinant Pertussis Toxin and FHA). The recombinant Pertussis Toxin (rPT) is a genetically-detoxified PT (PTgen) obtained by recombinant DNA technology. Boostagen meets the World Health Organisation (WHO) requirements for the manufacture of diphtheria, tetanus, and acellular pertussis combined vaccines.
Excipients/Inactive Ingredients: aluminum hydroxide, sodium chloride, water for injection.
Formaldehyde and thiomersal may be present in trace amounts as manufacturing process residuals.
Pharmacology: No established correlates of protection to pertussis antigens are currently available. Although efficacy or effectiveness data of Boostagen are not available for adolescents and adults including pregnant women, non-inferiority of the immune response of Boostagen was demonstrated as per WHO recommendations (TRS 979, 2013) in adolescents for anti-PT and anti-FHA antibody titers measured by ELISA and for seroconversion rates in a comparative randomized controlled trial with a licensed Tdap vaccine evaluated in effectiveness studies. Seroconversion is defined as ≥ 4 folds increase of antibody titers at 28 days after vaccination as compared to baseline titers.
The seroconversion rates of anti-PT and anti-FHA antibody titers were statistically significantly higher in subjects vaccinated with Boostagen (respectively 97% and 83%) than in subjects vaccinated with the Tdap comparator vaccine, respectively 55% and 54%. Immunogenicity of tetanus and diphtheria toxoids was similar to the Tdap comparator vaccine.
Boostagen is indicated for active booster immunization against tetanus, diphtheria and pertussis in individuals from the age of 3 years onwards.
For pertussis immunization in healthcare providers to prevent nosocomial transmission to infants and for maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated.
Boostagen is not indicated for primary immunisation.
A single 0.5 mL dose of Boostagen is recommended. Boostagen should be given in accordance with WHO and national recommendations or medical practices for booster vaccination and for maternal immunization: in the second or third trimester and preferably at least 15 days before the end of pregnancy; in adolescents and adults with an unknown or incomplete immunization against diphtheria or tetanus as part of vaccination program; for tetanus prophylaxis in wound management. Tetanus immunoglobulin should be administered in accordance with existing recommendations.
Mode of Administration: Shake the syringe well to obtain a uniform, cloudy and white suspension. Do not use if resuspension does not occur after vigorous shaking.
Boostagen should be administered by deep intramuscular injection, preferably in the deltoid region. Before injection, the skin over the site of injection should be cleaned with a suitable germicide. Open the needle cap of the pre-filled syringe, administer the total volume of 0.5 mL intramuscularly (IM).
Overdose is considered highly unlikely due to the presentation of Boostagen in monodose pre-filled syringe.
Boostagen should not be administered to individuals having shown signs of hypersensitivity or life-threatening reaction following administration of diphtheria, tetanus or pertussis vaccines or to any components of the vaccine.
Boostagen should not be administered to individuals having experienced any encephalopathy with unknown aetiology such as coma, prolonged seizures, or decreased level of consciousness within 7 days following previous vaccination with any whooping cough vaccine.
Boostagen should not be administered to individuals with progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy.
It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination in compliance with local requirements. The frequency and severity of adverse events in recipients of tetanus and diphtheria toxoids are influenced by the number of prior doses and level of pre-existing antitoxin antibody. As with all injectable vaccines, appropriate medical care should be readily available in case of a rare anaphylactic reaction after vaccination.
The vaccine should not be administered intravascularly.
Fractional doses (< 0.5 mL) should not be given.
As with other vaccines, administration of Boostagen to subjects suffering from acute severe febrile illness should be postponed. Boostagen should be administered with precautionary measures to subjects who had any of the following adverse events within 48 hours after a previous immunization with any whooping cough vaccines: high temperature (≥ 40°C) without any identifiable cause, convulsions and collapse or shock-like state.
Boostagen should be administered with caution to the recipient with any bleeding disorders, thrombocytopenia or anticoagulant therapy because bleeding at injection site may occur after intramuscular injection.
In the case of immunosuppressive treatment or immunodeficiency, the immune response to the vaccine may be diminished. Vaccination should be postponed until the end of treatment or resolution of disease. Nevertheless, in the case of chronic immunodeficiency, including HIV-infected persons, vaccination is recommended even if the response may be limited.
Pregnancy: In accordance with 2019 WHO recommendations for routine immunization of pertussis-containing vaccine, the use of Boostagen may be considered in the second or third trimester and preferably at least 15 days before the end of pregnancy.
Safety data from active post-marketing surveillance (including a prospective observational study) where 848 pregnant women were exposed to Boostagen in the second or third trimester of pregnancy have shown no vaccine related adverse effect on pregnancy or the health of newborns.
No adverse effects on pregnancy, parturition, lactation or prenatal and postnatal development were observed after administration of Boostagen in one animal toxicity study. Data in humans from randomized controlled trials on the use of Boostagen during the second or third trimester of pregnancy are not yet available. However, as with other inactivated vaccines, vaccination with Boostagen is not expected to be associated with any increased risk to the foetus.
Lactation: The effect of Boostagen during lactation has not been assessed in humans. Nevertheless, as Boostagen contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected.
Summary of the safety profile:
The safety profile presented as follows is based on data from a clinical trial where Boostagen was administered to adolescents between 12 and 17 years of age. Within 7 days after vaccination, the most common events occurring were local injection site reactions (pain, redness and induration) and systemic reactions (headache, fatigue, myalgia, malaise and arthralgia). Higher frequency of induration was observed in subjects vaccinated with Boostagen; however, all cases were mild or moderate in intensity and resolved in a few days without sequelae. For the other adverse events, the frequency, severity and duration were similar in subjects vaccinated either with Boostagen or with a licensed Tdap vaccine. These signs and symptoms were mostly mild and moderate in intensity and resolved without sequelae. (See table.)
Click on icon to see table/diagram/image
Interaction studies with other medicinal products or vaccines have not been performed. However, since Boostagen is an inactivated vaccine, administration of Boostagen concomitantly with other inactivated vaccines or immunoglobulins is unlikely to cause any interference with the immune response.
When considered necessary, Boostagen can be administered simultaneously with other inactivated vaccines or immunoglobulins at separate site of injections.
Immunosuppressive treatment may interfere the development of expected immune response.
Boostagen should be stored at 2°C to 8°C. Do not freeze. Discard if vaccine has been frozen.
Store in the original package in order to protect from light.
Shelf-Life: 3 years.
J07AJ52 - pertussis, purified antigen, combinations with toxoids ; Belongs to the class of pertussis bacterial vaccines.
Inj (pre-filled syringe) 0.5 mL x 1's.