Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents-A single blind …

N Pavia-Ruz, K Abarca, A Lepetic… - Human Vaccines & …, 2015 - Taylor & Francis
N Pavia-Ruz, K Abarca, A Lepetic, MY Cervantes-Apolinar, K Hardt, G Jayadeva…
Human Vaccines & Immunotherapeutics, 2015Taylor & Francis
Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™,
is indicated for booster vaccination of children, adolescents and adults. The original prefilled
disposable dTpa syringe presentation was recently replaced by another prefilled-syringe
presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10–
15 years who had previously received 5 or 6 previous DT (P)/dT (pa) vaccine doses, were
randomized (1: 1) to receive dTpa booster, injected using the new (dTpa-new) or previous …
Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10–15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine.
Taylor & Francis Online
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