Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

PHASE1CompletedINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2013

Conditions
PertussisWhooping CoughTetanusLockjawDiphtheria
Interventions
BIOLOGICAL

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

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.

BIOLOGICAL

Licensed TdaP booster vaccine

Licenced TdaP booster vaccine was administered 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.

OTHER

Saline solution

Subjects received one injection of saline solution at one month after vaccination.

Trial Locations (1)

185

Center for Vaccinology (CEVAC), Ghent University Hospital, De Pintelaan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY