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

Launched by SANOFI · Dec 10, 2009

Keywords

ClinConnect Summary

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).

Gender

ALL

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.