Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

PHASE1CompletedINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Pertussis
Interventions
BIOLOGICAL

aP booster

"Acellular pertussis vaccine:~Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.~Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine."

BIOLOGICAL

TdaP booster

"Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.~Other: Saline solution Subjects received one injection of saline solution at one month after vaccination."

BIOLOGICAL

Licensed TdaP booster (Boostrix®)

"Licensed TdaP booster vaccine Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.~Other: Saline solution Subjects received one injection of saline solution at one month after vaccination."

Trial Locations (1)

Unknown

Site 02, Center for Vaccinology (CEVAC), Ghent University Hospital, Ghent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY