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

• Conditions: Healthy volunteers: indicated for primary vaccination in infants for active immunization against diphtheria, tetanus, pertussis and poliomyelitis.; MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005403-87-Outside-EU/EEA
• Lead Sponsor: SANOFI PASTEUR SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial
enrollment:
1) Aged 4-6 years inclusive on the day of inclusion
2) Child having completed the three-dose vaccination and the booster
vaccination with DTacP-IPV//PRP~T combined vaccine (Pentaxim™) of the study E2I34
3) Informed consent form signed by the parent(s) or other legal representative
4) Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 167
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation in another clinical trial in the 4 weeks preceding the trial inclusion
2) Planned participation in another clinical trial during the present trial period
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
4) 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
5) Chronic illness at a stage that could interfere with trial conduct or completion
6) Blood or blood–derived products received in the past or current or planned administration during the trial (including immunoglobulins)
7) Any vaccination in the 4 weeks preceding the trial vaccination
8) History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
9) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
10) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
12) History of/current major neurological diseases or seizures
13) Febrile illness (temperature = 38°C) or acute illness on the day of inclusion.
14) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified