Recombinant pertussis toxin (rPT), filamentous haemagglutinin (FHA).
Each single dose (0.5 mL) contains Purified Bordetella pertussis antigens: Recombinant Pertussis Toxin (rPT) 5 µg, Filamentous Haemagglutinin (FHA) 5 µg.
Pertagen is a recombinant acellular pertussis vaccine. Pertagen is a sterile, whitish, turbid and uniform suspension. This vaccine contains purified Bordetella pertussis antigens (rPT and FHA) which are adsorbed on aluminum hydroxide. rPT (recombinant Pertussis Toxin) is a genetically-detoxified PT obtained by recombinant DNA technology. Pertagen meets the World Health Organisation requirements for the manufacture of biological substances and acellular pertussis vaccines.
Excipients/Inactive Ingredients: aluminum hydroxide, sodium chloride, water for injection.
Formaldehyde may be present as in trace amounts as a manufacturing process residual.
Pharmacology: No established correlates of protection to pertussis antigens are currently available. Although efficacy or effectiveness data of Pertagen are not available for adolescents and adults including pregnant women, non-inferiority of the immune response of Pertagen 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 study. 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 significant higher in subjects vaccinated with Pertagen (respectively 96% and 93%) than in subjects vaccinated with the Tdap comparator vaccine, respectively 55% and 54%. In addition, 1 month after booster vaccination, the neutralizing antibodies against PT antigen were also significantly higher with Pertagen than with the Tdap comparator vaccine.
Pertagen is indicated for active booster immunization against pertussis in individuals from the age of 11 years onwards. Pertagen may be considered as an alternative to combined tetanus, diphtheria and acellular pertussis vaccines in persons having received multiple and frequent tetanus and diphtheria vaccine doses including persons with known hypersensitivity to tetanus (Arthus-type hypersensitivity reaction) or diphtheria vaccines.
A single 0.5 mL dose of Pertagen is recommended. Pertagen should be given following the current local recommendation for booster vaccination against pertussis.
In accordance with 2019 WHO recommendations for routine immunization of pertussis-containing vaccine, the use of Pertagen may be considered in the second or third trimester and preferably at least 15 days before the end of pregnancy. See USE IN PREGNANCY & LACTATION.
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.
Pertagen 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 Pertagen in monodose pre-filled syringe.
Pertagen should not be administered to individuals having shown signs of hypersensitivity or life-threatening reaction following administration of pertussis vaccines or to any components of the vaccine.
Hypersensitivity to diphtheria and tetanus vaccines are not contraindication to the use of Pertagen.
Pertagen 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.
Pertagen 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. 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 Pertagen to subjects suffering from acute severe febrile illness should be postponed. Pertagen 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.
Pertagen 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: Maternal immunization can protect newborns and young infants who bear the brunt pertussis mortality (WHO Immunological Basis for Immunization Series, Module 4 Pertussis, 2017). In the USA, moderate to severe local reactions have been associated with high levels of tetanus and diphtheria antitoxin when tetanus toxoid was administered with a reduced amount of diphtheria toxoid. However, because of the potential benefits of maternal pertussis immunization and the lack of monovalent acellular pertussis vaccine in the USA, the Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women receive Tdap boosters during each pregnancy (WHO Global Advisory Committee on Vaccine Safety, 2014).
The previous WHO consideration supports the potential use of Pertagen, a monovalent acellular pertussis vaccine, for maternal pertussis immunization.
In accordance with 2019 WHO recommendations for routine immunization of pertussis-containing vaccine, the use of Pertagen 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 964 pregnant women were exposed to Pertagen (monovalent aP vaccine) or to the aP vaccine of Pertagen combined with tetanus toxoid and reduced diphtheria toxoid (TdaP vaccine, 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 in one animal toxicity study evaluating Pertagen antigens combined to tetanus and diphtheria toxoids. Data in humans from randomized controlled trials on the use of Boostagen (TdaP vaccine containing Pertagen antigens combined to tetanus and diphtheria toxoids) during the second or third trimester of pregnancy are not yet available. However, as with other inactivated vaccines, vaccination with Pertagen is not expected to be associated with any increased risk to the foetus.
Lactation: The effect of Pertagen during lactation has not been assessed in humans. Nevertheless, as Pertagen contains inactivated antigens, no risk to the breastfed infant should be expected.
Summary of the safety profile:
The safety profile presented below is based on data from a clinical trial where Pertagen 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 pain and systemic reactions (headache, fatigue, myalgia, malaise and arthralgia). Frequency, severity and duration of adverse reactions were similar in subjects vaccinated either with Pertagen 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 Pertagen is an inactivated vaccine, administration of Pertagen concomitantly with other inactivated vaccines or immunoglobulins is unlikely to cause any interference with the immune response.
When considered necessary, Pertagen 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.
Pertagen 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.
J07AJ02 - pertussis, purified antigen ; Belongs to the class of pertussis bacterial vaccines.
Inj (pre-filled syringe) 0.5 mL x 1's.