REPEVAX® can be safely administered as a booster one month after tetanus, diphtheria and poliomyelitis vaccination: an option for managing increasing incidence of Bordetella pertussis (whooping cough) infection

Abstract number: P1325

Beytout J., Launay O., Dubray C., Galtier F., Noize-Pin C., Guiso N., Baudin M., Richard P., Tran C., Ledesma E., Fiquet A., Baptiste C., Soubeyrand B.

Objectives: In France it is recommended to administer a booster dose of a pertussis-containing vaccine in adults which can result in them receiving 2 doses of tetanus (T) and/or diphtheria (D/d) and/or poliomyelitis (inactivated, IPV) containing vaccine within a short period (eg catch-up programme or pertussis outbreak). In children and teenagers it has been shown that boosters can be safely given with intervals as short as about 2 years, but in adults there are no data for intervals less than 5 years. We assessed the safety of a booster dose of a pertussis-containing vaccine (acellular component, aP) shortly after a Td-IPV booster.

Methods: 500 healthy adults 18–40 years, having received geqslant R: gt-or-equal, slanted5 doses of T, D and poliomyelitis vaccine by the age of 18, with the last dose of T and/or D and/or poliomyelitis vaccine given alone or combined at least 5 years previously, were randomised to receive either Td-IPV (REVAXIS®; Group 1) or placebo (Group 2) followed by Td5aP-IPV (REPEVAX®) in both groups one month later in a double-blind trial. Adverse events, including pre-listed events for the first 7 days (injection-site erythema, swelling, and pain, oral temperature geqslant R: gt-or-equal, slanted37.5°C, headache and myalgia) were recorded on a diary card.

Results: The groups were similar in terms of age, sex ratio, weight, height, number of previous vaccinations with D, T, and poliomyelitis and intervals between last D, T or poliomyelitis vaccination and study start. 484 subjects who received the second injection were included in the REPEVAX® safety analysis. The adverse event rates reported after REPEVAX® were similar in both groups except for a lower incidence of solicited injection-site reactions in subjects in Group 1.

In Group 1 the rates of injection-site swelling and pain reported within 7 days after REPEVAX® were lower than in Group 2 (19.4% vs 27.7% and 82.6% vs 92.1%, respectively). The confidence interval of the difference between groups did not include 0 (swelling: -8.3 [-15.7; -0.7], pain: -9.5 [-15.5; -3.6]), but this was not judged to be clinically meaningful.

Conclusion: These data support the use of REPEVAX® in adults, even one month after a booster with Td-IPV. REPEVAX® can be used as a booster to reduce the incidence of whooping cough.

Session Details

Date: 19/04/2008
Time: 00:00-00:00
Session name: 18th European Congress of Clinical Microbiology and Infectious Diseases
Location: Barcelona, Spain
Presentation type:
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