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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00404651
Eligibility Criteria:
Inclusion Criteria :
* Two months old infants on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one or both parents or by the guardian and two independent witnesses
* Able to attend all scheduled visits and to comply with all trial procedures
* Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
Exclusion Criteria :
* Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency
* 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 since birth
* Any vaccination in the four weeks preceding the first trial visit
* Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
* Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
* Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures
* Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT00404651
Study Brief:
Protocol Section:
NCT00404651