PMID- 19011374
OWN - NLM
STAT- MEDLINE
DCOM- 20091009
LR  - 20190516
IS  - 1554-8619 (Electronic)
IS  - 1554-8600 (Linking)
VI  - 5
IP  - 5
DP  - 2009 May
TI  - Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: 
      a placebo-controlled trial.
PG  - 315-21
AB  - 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.
FAU - Beytout, Jean
AU  - Beytout J
AD  - Services des Maladies Infectieuses et Tropicales, Centre Hospitalier 
      Universitaire Hotel Dieu, Clermont-Ferrand, France.
FAU - Launay, Odile
AU  - Launay O
FAU - Guiso, Nicole
AU  - Guiso N
FAU - Fiquet, Anne
AU  - Fiquet A
FAU - Baudin, Martine
AU  - Baudin M
FAU - Richard, Patrick
AU  - Richard P
FAU - Baptiste, Charles
AU  - Baptiste C
FAU - Soubeyrand, Benoit
AU  - Soubeyrand B
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090501
PL  - United States
TA  - Hum Vaccin
JT  - Human vaccines
JID - 101265291
RN  - 0 (DTPP vaccine)
RN  - 0 (Diphtheria Toxoid)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Pertussis Vaccine)
RN  - 0 (Placebos)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Tetanus Toxoid)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Diphtheria Toxoid/*adverse effects
MH  - Diphtheria-Tetanus-Pertussis Vaccine/*adverse effects
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - France
MH  - Headache/chemically induced
MH  - Humans
MH  - Immunization, Secondary/*methods
MH  - Male
MH  - Pain/chemically induced
MH  - Pertussis Vaccine/*adverse effects
MH  - Placebos/administration & dosage
MH  - Poliovirus Vaccine, Inactivated/*adverse effects
MH  - Skin Diseases/chemically induced/pathology
MH  - Tetanus Toxoid/*adverse effects
MH  - Vaccines, Combined
MH  - Young Adult
EDAT- 2008/11/18 09:00
MHDA- 2009/10/10 06:00
CRDT- 2008/11/18 09:00
PHST- 2008/11/18 09:00 [pubmed]
PHST- 2009/10/10 06:00 [medline]
PHST- 2008/11/18 09:00 [entrez]
AID - 6911 [pii]
AID - 10.4161/hv.5.5.6911 [doi]
PST - ppublish
SO  - Hum Vaccin. 2009 May;5(5):315-21. doi: 10.4161/hv.5.5.6911. Epub 2009 May 1.