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Hum Vaccin. 2009 May;5(5):315-21. Epub 2009 May 1.

Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: a placebo-controlled trial.

Author information

1
Services des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire Hôtel Dieu, Clermont-Ferrand, France.

Abstract

BACKGROUND:

In France, the only vaccines available for use as a pertussis booster in adults are combined vaccines containing adsorbed tetanus, diphtheria (adult formulation), acellular pertussis and inactivated poliovirus (Tdap-IPV). Adults may require a pertussis booster relatively soon after having received vaccines containing tetanus-diptheria antigens (Td) (occupational or familial circumstances such as new job, childbirth in recent past or future), although the safety of Tdap-IPV when administered soon after vaccination with Td is undocumented.

METHODS:

In this randomized, double-blind, multi-centre study, we assessed the safety of Tdap-IPV administered one month after vaccination with tetanus, diphtheria (adult formulation), inactivated poliovirus vaccination (Td-IPV) in healthy adults vaccinated according to the French vaccination calendar (seven tetanus-diphtheria vaccinations by age 18 years). Subjects received either Td-IPV (n = 249) or placebo (n = 251) followed 1 month later by Tdap-IPV. Any adverse events (AEs) were recorded.

RESULTS:

The safety of Tdap-IPV was similar when Tdap-IPV vaccine was administered one month after either Td-IPV or placebo: at seven days, 85.1% versus 93.4% subjects reported at least one reaction at the injection site, mainly pain (82.6% versus 92.1%); 40.5% versus 45.0%, at least one systemic AE (mainly headache: 26.4% versus 26.0%); fever concerned 1.7% of both groups. No serious vaccine-related AEs were reported. Both safety profiles corresponded to documented product characteristics.

CONCLUSIONS:

Tdap-IPV may be administered to adults one month after Td-IPV without exacerbating post-vaccination side-effects.

PMID:
19011374
DOI:
10.4161/hv.5.5.6911
[Indexed for MEDLINE]

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