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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 2, 2012
Last Updated Date	April 10, 2013
Start Date ^ICMJE	February 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 2, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01546909 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
Official Title ^ICMJE	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
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Diphtheria Tetanus Poliomyelitis
Intervention ^ICMJE	Biological: Diphtheria, tetanus, polio and pertussis vaccination 1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
Study Arm (s)	Experimental: TETRAVAC-ACELLULAIRE Intervention: Biological: Diphtheria, tetanus, polio and pertussis vaccination
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	278
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	11 Years to 13 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01546909
Other Study ID Numbers ^ICMJE	RVX01C
Has Data Monitoring Committee	No
Responsible Party	Sanofi Pasteur MSD
Study Sponsor ^ICMJE	Sanofi Pasteur MSD
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sanofi Pasteur MSD
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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