Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT01031303
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT01031303
Study Brief:
Protocol Section:
NCT01031303