Back to results

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

Primary Purpose

Diphtheria, Tetanus, Poliomyelitis

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Diphtheria, tetanus, polio and pertussis vaccination

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

11 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TETRAVAC-ACELLULAIRE

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL

Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL

Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)

Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)

Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)

Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL

Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL

Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)

Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)

Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)

Secondary Outcome Measures

Geometric mean titer for diphtheria

Geometric mean titer for tetanus

Geometric mean titer for polio type 1

Geometric mean titer for polio type 2

Geometric mean titer for polio type 3

Solicited injection site and solicited systemic reactions

Unsolicited injection site reactions and unsolicited systemic adverse events

Serious adverse events

Full Information

NCT ID

NCT01546909

First Posted

March 2, 2012

Last Updated

September 8, 2017

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01546909

Brief Title

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

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 2012 (Actual)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Tetanus, Poliomyelitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

278 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TETRAVAC-ACELLULAIRE

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Diphtheria, tetanus, polio and pertussis vaccination

Intervention Description

1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

Primary Outcome Measure Information:

Title

Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL

Time Frame

Pre-booster dose (Day 0)

Title

Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL

Time Frame

Pre-booster dose (Day 0)

Title

Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)

Time Frame

Pre-booster dose (Day 0)

Title

Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)

Time Frame

Pre-booster dose (Day 0)

Title

Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)

Time Frame

Pre-booster dose (Day 0)

Title

Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL

Time Frame

1 month post-booster dose

Title

Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL

Time Frame

1 month post-booster dose

Title

Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)

Time Frame

1 month post-booster dose

Title

Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)

Time Frame

1 month post-booster dose

Title

Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)

Time Frame

1 month post-booster dose

Secondary Outcome Measure Information:

Title

Geometric mean titer for diphtheria

Time Frame