INFORMATION FOR HEALTH PROFESSIONALS
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BOOSTRIX®-IPV contains diphtheria toxoid, tetanus toxoid, and three purified pertussis antigens (pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69 kiloDalton outer membrane protein)) adsorbed on aluminium salts. It also contains three types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain).
The diphtheria and tetanus toxoids obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani are inactivated and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I Bordetella pertussis from which the PT, FHA and pertactin are extracted and purified. FHA and pertactin are treated with formaldehyde, PT is treated with glutaraldehyde and formaldehyde, and irreversibly inactivated.
The three polioviruses are cultivated on a continuous VERO cell line, purified and inactivated with formaldehyde.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
BOOSTRIX®-IPV meets the World Health Organisation requirements for the manufacture of biological substances, of diphtheria, tetanus, pertussis and combined vaccines, and of inactivated poliomyelitis vaccines.
A 0.5 ml dose of vaccine contains not less than 2 IU ( ≈ min. 2.5 Lf) of adsorbed diphtheria toxoid, not less than 20 IU (≈ min. 5 Lf) of adsorbed tetanus toxoid, 8 µg of PT, 8 µg of FHA, 2.5 µg of pertactin, 40 D antigen units of type 1 (Mahoney), 8 D antigen units of type 2 (MEF-1) and 32 D antigen units of type 3 (Saukett) of the polio virus.
Suspension, Injection.
BOOSTRIX®-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of seven years onwards (see DOSAGE AND ADMINISTRATION).
BOOSTRIX®-IPV is not intended for primary immunisation.
Not applicable
A single 0.5 ml dose of the vaccine is recommended.
BOOSTRIX®-IPV may be administered from the age of seven years onwards. BOOSTRIX®-IPV should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that provide low (adult) dose diphtheria toxoid plus tetanus toxoid in combination with pertussis and poliomyelitis antigens.
Individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids should not be vaccinated with BOOSTRIX®-IPV. BOOSTRIX®-IPV is not precluded in subjects with an incomplete, or no, history of previous pertussis or polio vaccination. However a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection.
BOOSTRIX®-IPV can be used in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.
There are no data on the duration of protection against pertussis following vaccination with BOOSTRIX®-IPV.
Repeat vaccination against diphtheria, tetanus and poliomyelitis should be performed at intervals as per official recommendations.
BOOSTRIX®-IPV is for deep intramuscular injection preferably in the deltoid region.
BOOSTRIX®-IPV should not be administered to subjects with known hypersensitivity after previous administration of diphtheria, tetanus, pertussis or poliomyelitis vaccines or to any component of the vaccine (see PHARMACEUTICAL PARTICULARS).
BOOSTRIX®-IPV contains traces of neomycin and polymyxin. The vaccine should not be used in subjects with known hypersensitivity to neomycin and polymyxin.
BOOSTRIX®-IPV is contra-indicated if the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.
As with other vaccines, administration of BOOSTRIX®-IPV should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contra-indication.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine in infancy, the decision to give doses of pertussis-containing vaccines should be carefully considered:
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) immunisation until the condition is corrected or stable. However, the decision to give pertussis vaccine must be made on an individual basis after careful consideration of the risks and benefits.
BOOSTRIX®-IPV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
BOOSTRIX®-IPV should in no circumstances be administered intravascularly.
A history or a family history of convulsions and a family history of an adverse event following DTP vaccination do not constitute contra-indications.
HIV infection is not considered as a contra-indication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Concomitant administration of BOOSTRIX®-IPV and other vaccines has not specifically been studied. However, BOOSTRIX®-IPV can be given concomitantly with other vaccines taking into account generally accepted vaccine practices and recommendations.
As with other vaccines, patients receiving immunosuppressive therapy or patients with immunodeficiency may not achieve an adequate response.
Adequate human data on the use of BOOSTRIX®-IPV during pregnancy are not available. However, animal studies showed no reproductive toxicity or teratogenic effects. As with other inactivated vaccines, one does not expect vaccination with BOOSTRIX®-IPV to harm the fetus. However, the vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the fetus.
Adequate data on the administration of BOOSTRIX®-IPV to women who are breastfeeding their infants are not available. BOOSTRIX®-IPV should be administered to women who are breastfeeding only when clearly needed.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
More than 1500 vaccinees have received a dose of BOOSTRIX®-IPV in clinical studies. The most common events occurring after vaccine administration were local injection site reactions (pain, redness and swelling) reported by 33.5 - 66.9% of subjects overall. These had their onset within the first day after vaccination. All resolved without sequelae.
Collapse or shock-like state (hypotonic-hyporesponsive episode) and convulsions have been reported very rarely following immunisation of children with products containing one or more of the antigenic constituents of BOOSTRIX®-IPV.
Adverse events with at least a suspected causal relationship to vaccination are listed below.
Frequencies are reported as:
Very common: ≥ 10%
Common: ≥ 1% and < 10%
Uncommon: ≥ 0.1% and < 1%
Rare: ≥ 0.01% and < 0.1%
Very rare: < 0.01%
Very common: pain, redness, swelling
Common: injection site reaction
Very common: fatigue
Common: fever
Very common: headache
Uncommon: dizziness
Common: loss of appetite, gastro-intestinal symptoms
Uncommon: arthralgia, myalgia
Common: drowsiness, irritability
Uncommon: pruritus
Uncommon: lymphadenopathy
The reactogenicity of revaccination with BOOSTRIX®-IPV has not been evaluated.
As observed during post-marketing surveillance with other vaccines, allergic reactions including anaphylactoid reactions may very rarely occur.
No case of overdose has been reported.
Pharmaco-therapeutic group: Bacterial vaccines combined, ATC code J07CA
One month post vaccination with BOOSTRIX®-IPV, immune responses in 1469 subjects were the following:
| Antigen | Response (% vaccinees) |
Adults, adolescents and children from the age of 4 years onwards* |
|---|---|---|
| Diphtheria | ≥ 0.1 IU/ml | 83.5 - 100% |
| Tetanus | ≥ 0.1 IU/ml | 99.6 - 100% |
| Pertussis | ||
| Pertussis toxoid | Vaccine response | 94.2 - 97.8% |
| Filamentous haemagglutinin | Vaccine response | 90.1 - 97.2% |
| Pertactin | Vaccine response | 96.5 - 99.3% |
| Inactivated poliomyelitis | ||
| Type 1 | Seroprotection ≥ 8 | 99.6 - 100% |
| Type 2 | Seroprotection ≥ 8 | 99.6 - 100% |
| Type 3 | Seroprotection ≥ 8 | 99.1 - 100% |
*In clinical studies, seroprotection and vaccine response rates to all antigens after a booster dose of BOOSTRIX®-IPV were similar to the licensed controlled vaccines studied.
As with other adult-type Td vaccines, BOOSTRIX®-IPV induces higher seroprotection rates and higher titres of both anti-D and anti-T antibodies in children and adolescents as compared to adults.
The pertussis antigens contained in BOOSTRIX®-IPV are an integral part of the paediatric acellular pertussis combination vaccine (INFANRIX®), for which efficacy after primary vaccination has been demonstrated in the following 3-dose primary studies :
Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of the vaccine was 88.7%.
The vaccine efficacy was found to be 84%. In a follow-up of the same cohort, efficacy persisted undiminished up to 5 years after completion of primary vaccination without administration of a booster dose against pertussis.
This study assessed duration of protection of INFANRIX given in a 3-dose schedule to infants. A similar duration of protection cannot be assumed to apply to older children or adults given a single dose of BOOSTRIX-IPV, regardless of previous vaccination against pertussis.
Although the protective efficacy of BOOSTRIX-IPV has not been demonstrated in adolescents and adult age groups, vaccinees in these age groups who received BOOSTRIX-IPV achieved anti-pertussis antibody titres greater than those in the German household contact study where the protective efficacy of INFANRIX was 88.7%.
There are currently no data which demonstrate a reduction of transmission of pertussis after immunisation with BOOSTRIX-IPV. However, it could be expected that immunisation of immediate close contacts of newborn infants, such as parents, grandparents and healthcare workers, would reduce exposure of pertussis to infants not yet adequately protected through immunisation.
The immunogenicity of revaccination with BOOSTRIX®-IPV has not been evaluated.
Evaluation of pharmacokinetic properties is not required for vaccines.
Medium 199 (as stabilizer containing amino acids, mineral salts, vitamins and
other substances)
Sodium chloride
Water for injections.
BOOSTRIX®-IPV should not be mixed with other vaccines in the same syringe.
The expiry date of the vaccine is indicated on the label and packaging.
The shelf life of the vaccine is 3 years.
BOOSTRIX®-IPV should be stored at +2°C to +8°C.
The vaccine should not be frozen. Discard if it has been frozen.
BOOSTRIX®-IPV is a turbid white suspension presented in a prefilled syringe. Upon storage, a white deposit and clear supernatant can be observed.
The prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
Prior to vaccination, the vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Upon removal from refrigerator, the vaccine is stable for 8 hours at + 21°C.
Prescription Medicine
Prefilled syringes in packs of 1 or 10.
Syringes come with or without needles.
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert and Customs Streets
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
Telephone: (09) 367 2900
Facsimile: (09) 367 2506
4 January 2007
BOOSTRIX® and INFANRIX® are registered trade marks of the GlaxoSmithKline group of companies.