Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial.
Hum Vaccin Immunother
; 11(7): 1770-4, 2015.
Article
en En
| MEDLINE
| ID: mdl-26075317
ABSTRACT
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 (11) 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.
Palabras clave
ANCOVA, analysis of co-variance; ATP, according to protocol; CI, confidence interval; El.U, Elisa units; FHA, filamentous hemagglutinin; GI, gastrointestinal; GMC, geometric mean concentration; IU, international units; LL, lower limit; PRN, pertactin; PT, pertussis toxin; SAE, serious adverse event; TVC, total vaccinated cohort; UL, upper limit; booster; dTpa, reduced-antigen-content diphtheria tetanus and acellular pertussis vaccine; diphtheria; pertussis; syringe presentation; tetanus
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Jeringas
/
Vacunas contra Difteria, Tétanos y Tos Ferina Acelular
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Revista:
Hum Vaccin Immunother
Año:
2015
Tipo del documento:
Article
País de afiliación:
México