Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: a placebo-controlled trial.
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.
Beytout
Jean
J
Services des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire Hôtel Dieu, Clermont-Ferrand, France.
Launay
Odile
O
Guiso
Nicole
N
Fiquet
Anne
A
Baudin
Martine
M
Richard
Patrick
P
Baptiste
Charles
C
Soubeyrand
Benoît
B
D000293:Adolescent; D000328:Adult; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D008297:Male; D010146:Pain / Q000139:chemically induced; D010567:Pertussis Vaccine / Q000009:adverse effects*; D010919:Placebos / Q000008:administration & dosage; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects*; D012871:Skin Diseases / Q000139:chemically induced / Q000473:pathology; D013745:Tetanus Toxoid / Q000009:adverse effects*; D017778:Vaccines, Combined; D055815:Young Adult
C051021:DTPP vaccine; D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D010567:Pertussis Vaccine; D010919:Placebos; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined