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

NCT01529645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2016-04-04

Study results available
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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

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.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

  • Geert Leroux-Roels, Prof. Dr. · Center for Vaccinology (CEVAC), Ghent University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-07-31
Completion
2013-07-31

Countries

  • Belgium

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01529645 on ClinicalTrials.gov