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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01529645
First received: February 6, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Pertussis
Whooping Cough
Tetanus
Lockjaw
Diphtheria
Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Biological: Licensed comparator Tdap booster vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • assess the safety profiles of all study vaccines against comparator, as measured by local and systemic reactions, patient reported outcomes and adverse events/serious adverse events (AEs/SAEs) [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]
  • select up to 4 vaccine dose candidates for further study based on immunogenicity responses to antigen components at Day 30 provided the safety profiles are comparable. [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]
  • evaluate antibody titers for Pertussis and Seroresponse rates for Diphtheria, and Tetanus antigens prior to and 1 month following vaccination. [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluate Seroresponse rates for Pertussis antigens and antibody titers to Diphtheria, and Tetanus Prior to and 1 month following vaccination. [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: aP booster Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 2: aP booster Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 3: aP booster Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 4: Tdap booster Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 5: Tdap booster Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 6: Tdap booster Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 7: Tdap booster Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 8: Tdap booster Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Experimental: Group 9: Tdap booster Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
Active Comparator: Group 10: Licensed Tdap booster Biological: Licensed comparator Tdap booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female individuals 18 to 40 years of age

Exclusion Criteria:

  • Recent exposure to Tetanus, Diphtheria or pertussis disease or vaccination with T, D or pertussis (aP or whole cell) containing vaccine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529645

Locations
Belgium
Center for vaccinology, University Hospital, BC 001
de Pintelaan, B-9000 Gent, Belgium, 185
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01529645     History of Changes
Other Study ID Numbers: V113_01, 2011-000688-28
Study First Received: February 6, 2012
Last Updated: July 17, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:
pertussis
booster vaccine
tetanus
diphtheria in adults

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014