Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01546909
First received: March 2, 2012
Last updated: April 10, 2013
Last verified: April 2013

March 2, 2012
April 10, 2013
February 2012
December 2012   (final data collection date for primary outcome measure)
  • Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL [ Time Frame: Pre-booster dose (Day 0) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL [ Time Frame: Pre-booster dose (Day 0) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution) [ Time Frame: Pre-booster dose (Day 0) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution) [ Time Frame: Pre-booster dose (Day 0) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution) [ Time Frame: Pre-booster dose (Day 0) ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL [ Time Frame: 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL [ Time Frame: 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution) [ Time Frame: 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution) [ Time Frame: 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution) [ Time Frame: 1 month post-booster dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01546909 on ClinicalTrials.gov Archive Site
  • Geometric mean titer for diphtheria [ Time Frame: Pre-booster (Day 0) and 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Geometric mean titer for tetanus [ Time Frame: Pre-booster (Day 0) and 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Geometric mean titer for polio type 1 [ Time Frame: Pre-booster (Day 0) and 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Geometric mean titer for polio type 2 [ Time Frame: Pre-booster (Day 0) and 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Geometric mean titer for polio type 3 [ Time Frame: Pre-booster (Day 0) and 1 month post-booster dose ] [ Designated as safety issue: No ]
  • Solicited injection site and solicited systemic reactions [ Time Frame: From Day 0 to Day 7 post vaccination ] [ Designated as safety issue: Yes ]
  • Unsolicited injection site reactions and unsolicited systemic adverse events [ Time Frame: From Day 0 to Day 28 days post vaccination ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: From signature of informed consent up to last study visit of the subject ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE

PRIMARY OBJECTIVES

  • To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
  • To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

  • To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
  • To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
  • To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Poliomyelitis
Biological: Diphtheria, tetanus, polio and pertussis vaccination
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
Experimental: TETRAVAC-ACELLULAIRE
Intervention: Biological: Diphtheria, tetanus, polio and pertussis vaccination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301

Exclusion Criteria:

  • Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
  • Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
  • Known or suspected immune dysfunction
  • Receipt of medications / vaccination that may interfere with study assessments
  • Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
  • Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
  • Any medical condition that might interfere with the evaluation of the study objectives
  • Febrile illness
Both
11 Years to 13 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01546909
RVX01C
No
Sanofi Pasteur MSD
Sanofi Pasteur MSD
Not Provided
Not Provided
Sanofi Pasteur MSD
April 2013

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