Abstract | UNLABELLED: In adults with a tetanus-prone injury, combined vaccines such as Tdap-IPV (REPEVAX®) can boost immunity against several diseases simultaneously. This Phase IIIb, parallel-group, open-label trial compared antibody responses to Tdap-IPV and tetanus monovalent vaccine (TMV; Vaccin Tétanique Pasteur® or Tetavax®) against tetanus toxoid 10 and 28 d post-vaccination. Between July and December 2009, four centers in France and five in Germany recruited healthy adults who had received a tetanus-containing vaccine 5-10 y previously. Participants were randomized 1:1 to receive at the first visit a single dose (0.5 mL) of Tdap-IPV or TMV, with follow-up visits at Day 10 and Day 28. OUTCOMES: per protocol (PP) population immunogenicity at Day 10 (primary) and at Day 28 (secondary); safety throughout the study. Of 456 adults randomized, 223 received Tdap-IPV and 233 received TMV (PP population: 183 and 199 participants, respectively). All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti- tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: -1.2, 3.6). Number of adverse events reported was comparable in each group. Injection-site reactions were reported by 76.6% participants receiving Tdap-IPV and 74.6% receiving TMV. Systemic events (e.g., malaise, myalgia and headache) were reported in 47.7% and 39.7% of the Tdap-IPV and the TMV groups, respectively. Tdap-IPV is effective and well-tolerated for use in the management of tetanus-prone injuries in emergency settings in persons for whom a booster against diphtheria, pertussis and poliomyelitis is also needed.
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Authors | Henri Laurichesse, Ulrich Zimmermann, Florence Galtier, Odile Launay, Xavier Duval, Patrick Richard, Christine Sadorge, Benoit Soubeyrand |
Journal | Human vaccines & immunotherapeutics
(Hum Vaccin Immunother)
Vol. 8
Issue 12
Pg. 1875-81
(Dec 01 2012)
ISSN: 2164-554X [Electronic] United States |
PMID | 23032160
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Bacterial
- Diphtheria-Tetanus-acellular Pertussis Vaccines
- Haemophilus Vaccines
- Vaccines, Combined
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Topics |
- Adult
- Antibodies, Bacterial
(blood)
- Diphtheria-Tetanus-acellular Pertussis Vaccines
(administration & dosage, adverse effects, immunology)
- Drug-Related Side Effects and Adverse Reactions
(epidemiology, pathology)
- Female
- France
- Germany
- Haemophilus Vaccines
(administration & dosage, adverse effects, immunology)
- Humans
- Male
- Middle Aged
- Prevalence
- Tetanus
(prevention & control)
- Vaccines, Combined
(administration & dosage, adverse effects, immunology)
- Wounds and Injuries
(complications)
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