NCT01529645

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

Phase I, Randomized, Controlled, Observer-Blind, Dose-Ranging Study of Acellular Pertussis and Tetanus-Diptheria-Acellular Pertussis Booster Vaccine in Adults Ages 18 to 40 Years.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.

Conditions

• Pertussis
• Whooping Cough
• Tetanus
• Lockjaw
• Diphtheria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-07-01
• Completion: 2013-07-01
• First posted: 2012-02-09
• Last updated: 2016-04-04
• Results posted: 2014-09-18

Locations

1 site across 1 country: Belgium