Clinical trial NCT01546909: Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Poliomyelitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 278
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
timeFrame: Pre-booster dose (Day 0)
measure: Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
timeFrame: Pre-booster dose (Day 0)
measure: Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)
timeFrame: Pre-booster dose (Day 0)
measure: Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)
timeFrame: Pre-booster dose (Day 0)
measure: Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)
timeFrame: Pre-booster dose (Day 0)
measure: Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
timeFrame: 1 month post-booster dose
measure: Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
timeFrame: 1 month post-booster dose
measure: Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)
timeFrame: 1 month post-booster dose
measure: Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)
timeFrame: 1 month post-booster dose
measure: Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)
timeFrame: 1 month post-booster dose
Secondary outcomes:
measure: Geometric mean titer for diphtheria
timeFrame: Pre-booster (Day 0) and 1 month post-booster dose
measure: Geometric mean titer for tetanus
timeFrame: Pre-booster (Day 0) and 1 month post-booster dose
measure: Geometric mean titer for polio type 1
timeFrame: Pre-booster (Day 0) and 1 month post-booster dose
measure: Geometric mean titer for polio type 2
timeFrame: Pre-booster (Day 0) and 1 month post-booster dose
measure: Geometric mean titer for polio type 3
timeFrame: Pre-booster (Day 0) and 1 month post-booster dose
measure: Solicited injection site and solicited systemic reactions
timeFrame: From Day 0 to Day 7 post vaccination
measure: Unsolicited injection site reactions and unsolicited systemic adverse events
timeFrame: From Day 0 to Day 28 days post vaccination
measure: Serious adverse events
timeFrame: From signature of informed consent up to last study visit of the subject
Other outcomes:
Locations:
city: Angers
country: France
facility: SPMSD Investigational Site 120
city: Arras
country: France
facility: SPMSD Investigational Site 103
city: Asnieres
country: France
facility: SPMSD Investigational Site 155
city: Bersee
country: France
facility: SPMSD Investigational Site 125
city: Besancon
country: France
facility: SPMSD Investigational Site 121
city: Besancon
country: France
facility: SPMSD Investigational Site 141
city: Blois
country: France
facility: SPMSD Investigational Site 124
city: Blois
country: France
facility: SPMSD Investigational Site 161
city: Boulogne Billancourt
country: France
facility: SPMSD Investigational Site 194
city: Brest
country: France
facility: SPMSD Investigational Site 148
city: Caen
country: France
facility: SPMSD Investigational Site 117
city: Caen
country: France
facility: SPMSD Investigational Site 147
city: Chalons En Champagne
country: France
facility: SPMSD Investigational Site 135
city: Champdeniers
country: France
facility: SPMSD Investigational Site 163
city: Chigny Les Roses
country: France
facility: SPMSD Investigational Site 145
city: Cholet
country: France
facility: SPMSD Investigational Site 157
city: Clamart
country: France
facility: SPMSD Investigational Site 101
city: Collombey Les Belles
country: France
facility: SPMSD Investigational Site 160
city: Collombey Les Belles
country: France
facility: SPMSD Investigational Site 162
city: DAX
country: France
facility: SPMSD Investigational Site 139
city: Draguignan
country: France
facility: SPMSD Investigational Site 193
city: Essey Les Nancy
country: France
facility: SPMSD Investigational Site 106
city: Essey Les Nancy
country: France
facility: SPMSD Investigational Site 123
city: Essey Les Nancy
country: France
facility: SPMSD Investigational Site 164
city: Floirac
country: France
facility: SPMSD Investigational Site 136
city: Frouard
country: France
facility: SPMSD Investigational Site 114
city: Haguenau
country: France
facility: SPMSD Investigational Site 150
city: Illkirch Graffenstaden
country: France
facility: SPMSD Investigational Site 113
city: Le Havre
country: France
facility: SPMSD Investigational Site 197
city: Le Havre
country: France
facility: SPMSD Investigational Site 198
city: Lingolsheim
country: France
facility: SPMSD Investigational Site 107
city: Louverne
country: France
facility: SPMSD Investigational Site 115
city: Manduel
country: France
facility: SPMSD Investigational Site 140
city: Maromme
country: France
facility: SPMSD Investigational Site 116
city: Marseille
country: France
facility: SPMSD Investigational Site 153
city: Montpellier
country: France
facility: SPMSD Investigational Site 134
city: Nogent Sur Marne
country: France
facility: SPMSD Investigational Site 129
city: Ostwald
country: France
facility: SPMSD Investigational Site 133
city: Poitiers
country: France
facility: SPMSD Investigational Site 128
city: Pont A Mousson
country: France
facility: SPMSD Investigational Site 130
city: Quimper
country: France
facility: SPMSD Investigational Site 151
city: Rouen
country: France
facility: SPMSD Investigational Site 102
city: Rouen
country: France
facility: SPMSD Investigational Site 110
city: Rouen
country: France
facility: SPMSD Investigational Site 199
city: Saint Ouen
country: France
facility: SPMSD Investigational Site 152
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References: