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

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Sanofi

Status and phase

Completed
Phase 4

Conditions

Poliomyelitis
Diphtheria
Pertussis
Tetanus

Treatments

Biological: DTacP-IPV combined vaccine (TETRAXIM™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01031303
UTN: U1111-1112-2680 (Other Identifier)
E2I57

Details and patient eligibility

About

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.

Full 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).

Enrollment

123 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

123 participants in 1 patient group

Study Group
Experimental group
Treatment:
Biological: DTacP-IPV combined vaccine (TETRAXIM™)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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