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
  Purpose

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

Condition Intervention Phase
Diphtheria
Tetanus
Poliomyelitis
Biological: Diphtheria, tetanus, polio and pertussis vaccination
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 278
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TETRAVAC-ACELLULAIRE Biological: Diphtheria, tetanus, polio and pertussis vaccination
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

  Eligibility

Ages Eligible for Study:   11 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01546909

Locations
France
SPMSD Investigational Site 120
Angers, France
SPMSD Investigational Site 103
Arras, France
SPMSD Investigational Site 155
Asnieres, France
SPMSD Investigational Site 125
Bersee, France
SPMSD Investigational Site 141
Besancon, France
SPMSD Investigational Site 121
Besancon, France
SPMSD Investigational Site 161
Blois, France
SPMSD Investigational Site 124
Blois, France
SPMSD Investigational Site 194
Boulogne Billancourt, France
SPMSD Investigational Site 148
Brest, France
SPMSD Investigational Site 147
Caen, France
SPMSD Investigational Site 117
Caen, France
SPMSD Investigational Site 135
Chalons En Champagne, France
SPMSD Investigational Site 163
Champdeniers, France
SPMSD Investigational Site 145
Chigny Les Roses, France
SPMSD Investigational Site 157
Cholet, France
SPMSD Investigational Site 101
Clamart, France
SPMSD Investigational Site 162
Collombey Les Belles, France
SPMSD Investigational Site 160
Collombey Les Belles, France
SPMSD Investigational Site 139
DAX, France
SPMSD Investigational Site 193
Draguignan, France
SPMSD Investigational Site 106
Essey Les Nancy, France
SPMSD Investigational Site 164
Essey Les Nancy, France
SPMSD Investigational Site 123
Essey Les Nancy, France
SPMSD Investigational Site 136
Floirac, France
SPMSD Investigational Site 114
Frouard, France
SPMSD Investigational Site 150
Haguenau, France
SPMSD Investigational Site 113
Illkirch Graffenstaden, France
SPMSD Investigational Site 198
Le Havre, France
SPMSD Investigational Site 197
Le Havre, France
SPMSD Investigational Site 107
Lingolsheim, France
SPMSD Investigational Site 115
Louverne, France
SPMSD Investigational Site 140
Manduel, France
SPMSD Investigational Site 116
Maromme, France
SPMSD Investigational Site 153
Marseille, France
SPMSD Investigational Site 134
Montpellier, France
SPMSD Investigational Site 129
Nogent Sur Marne, France
SPMSD Investigational Site 133
Ostwald, France
SPMSD Investigational Site 128
Poitiers, France
SPMSD Investigational Site 130
Pont A Mousson, France
SPMSD Investigational Site 151
Quimper, France
SPMSD Investigational Site 102
Rouen, France
SPMSD Investigational Site 110
Rouen, France
SPMSD Investigational Site 199
Rouen, France
SPMSD Investigational Site 152
Saint Ouen, France
Sponsors and Collaborators
Sanofi Pasteur MSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01546909     History of Changes
Other Study ID Numbers: RVX01C
Study First Received: March 2, 2012
Last Updated: April 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Diphtheria
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014