Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
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ClinicalTrials.gov Identifier: NCT01031303 |
Recruitment Status :
Completed
First Posted : December 14, 2009
Last Update Posted : October 5, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Poliomyelitis | Biological: DTacP-IPV combined vaccine (TETRAXIM™) | Phase 4 |
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).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 123 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 Start Date : | December 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Study Group |
Biological: DTacP-IPV combined vaccine (TETRAXIM™)
0.5 mL, Intramuscular
Other Name: TETRAXIM™ |
- To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination. [ Time Frame: 30 days post-vaccination ]
- To provide information concerning the safety after booster administration of TETRAXIM™. [ Time Frame: 30 days post-vaccination and entire study period ]

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Ages Eligible for Study: | 4 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031303
Thailand | |
Bangkok, Thailand, 10330 | |
Bangkok, Thailand, 10400 |
Study Director: | Medical Director | sanofi pasteur SA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01031303 |
Other Study ID Numbers: |
E2I57 UTN: U1111-1112-2680 ( Other Identifier: WHO ) |
First Posted: | December 14, 2009 Key Record Dates |
Last Update Posted: | October 5, 2011 |
Last Verified: | October 2011 |
Diphtheria Tetanus Pertussis |
Poliomyelitis PENTAXIM™ TETRAXIM™ |
Whooping Cough Tetanus Diphtheria Poliomyelitis Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections |
Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Central Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |