Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
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
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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
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 May 23, 2013