NCT02382913

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

Phase 1 Extension Study to Evaluate Antibody Persistence Approximately 3 Years After Administration of Different Dosages of Acellular Pertussis or Tetanus-Diphtheria-acellular Pertussis Booster Vaccines in Healthy Adult Subjects Enrolled in Study V113_01

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 43 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113\_01 study. There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn. No vaccine was administered and no safety data was collected in this study.

Conditions

• Pertussis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-03-09
• Last updated: 2016-03-24
• Results posted: 2016-02-12

Locations

1 site across 1 country: Belgium