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

February 6, 2012
July 17, 2013
March 2012
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01529645 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Pertussis
  • Whooping Cough
  • Tetanus
  • Lockjaw
  • Diphtheria
  • 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
  • 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
  • Biological: Licensed comparator Tdap booster vaccine
    Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
  • Experimental: Group 1: aP booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
  • Experimental: Group 2: aP booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
  • Experimental: Group 3: aP booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
  • Experimental: Group 4: Tdap booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
  • Experimental: Group 5: Tdap booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
  • Experimental: Group 6: Tdap booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
  • Experimental: Group 7: Tdap booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
  • Experimental: Group 8: Tdap booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
  • Experimental: Group 9: Tdap booster
    Intervention: Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
  • Active Comparator: Group 10: Licensed Tdap booster
    Intervention: Biological: Licensed comparator Tdap booster vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
July 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01529645
V113_01, 2011-000688-28
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP