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Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

DTacP-IPV combined vaccine (TETRAXIM™)

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Poliomyelitis, PENTAXIM™, TETRAXIM™

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

Aged 4-6 years inclusive on the day of inclusion
Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) of the study E2I34
Informed consent form signed by the parent(s) or other legal representative
Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

Participation in another clinical trial in the 4 weeks preceding the trial inclusion
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
Chronic illness at a stage that could interfere with trial conduct or completion
Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
Any vaccination in the 4 weeks preceding the trial vaccination
History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection
Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of/current major neurological diseases or seizures
Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion.
Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as
encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,
temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause
inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,
hypotonic hyporesponsive episode within 48 hours following vaccine injection,
seizures with or without fever within 3 days following vaccine injection.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.

Secondary Outcome Measures

To provide information concerning the safety after booster administration of TETRAXIM™.

Full Information

NCT ID

NCT01031303

First Posted

December 10, 2009

Last Updated

October 4, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01031303

Brief Title

Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

Official Title

Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations. Primary Objective : To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age. Secondary Objectives : To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age. To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age. To describe the safety after the booster dose of the study vaccine.

Detailed Description

All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age. Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).

6. Conditions and Keywords

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

Diphtheria, Tetanus, Pertussis, Poliomyelitis

Keywords

Diphtheria, Tetanus, Pertussis, Poliomyelitis, PENTAXIM™, TETRAXIM™

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

DTacP-IPV combined vaccine (TETRAXIM™)

Other Intervention Name(s)

TETRAXIM™

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.

Time Frame

30 days post-vaccination

Secondary Outcome Measure Information:

Title

To provide information concerning the safety after booster administration of TETRAXIM™.

Time Frame

30 days post-vaccination and entire study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Aged 4-6 years inclusive on the day of inclusion Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) of the study E2I34 Informed consent form signed by the parent(s) or other legal representative Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria : Participation in another clinical trial in the 4 weeks preceding the trial inclusion Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins) Any vaccination in the 4 weeks preceding the trial vaccination History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34 Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current major neurological diseases or seizures Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion. Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine, temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection, hypotonic hyporesponsive episode within 48 hours following vaccine injection, seizures with or without fever within 3 days following vaccine injection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

sanofi pasteur SA

Official's Role

Study Director

Facility Information:

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

23077849

Citation

Pancharoen C, Chotpitayasunondh T, Chuenkitmongkol S, Ortiz E. Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children. Southeast Asian J Trop Med Public Health. 2012 May;43(3):687-98.

Results Reference

derived

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

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Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

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