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Q In adolescents and adults, is a 5 component acellular pertussis vaccine combined with tetanus and diphtheria toxoids (Tdap) as immunogenic and as safe as the licensed tetanus and diphtheria toxoid (Td) vaccine?
Clinical impact ratings GP/FP/Primary care ★★★★★★☆ Internal medicine ★★★★★☆☆ Infectious disease ★★★★★★☆
METHODS
Design:
randomised controlled trial.
Allocation:
concealed.
Blinding:
blinded (patients, healthcare providers, outcome assessors, and laboratory personnel).
Follow up period:
28 days for immunogenicity and 6 months for safety.
Setting:
39 clinical centres in the US.
Participants:
4480 healthy adolescents and adults with body temperature <38.0°C. Exclusion criteria included receipt of any pertussis, diphtheria, or tetanus containing vaccines in the past 5 years; diagnosis of pertussis within 2 years; allergy or sensitivity …
Footnotes
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* See glossary.
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For correspondence: Dr M E Pichichero, University of Rochester Medical Center, Rochester, NY,USA. michael_pichichero{at}urmc.rochester.edu
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Source of funding: Sanofi Pasteur.
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