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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02817451
Eligibility Criteria:
Inclusion Criteria:
(Screening Criteria for the participants mother)
* At least 18 years of age at the time of the Screening blood sample draw
* Self-reported or maternity-reported HIV infection in the mother
Inclusion Criteria:
* Born to an adult mother and aged 35 to 56 days (between 5 and 8 weeks of age) on the day of inclusion
* Group A participants must be HIV infected, as documented through the results of a polymerase chain reaction (PCR) test, and following an anti-retroviral therapy according to the national recommendations; and Group B participants must be HIV exposed uninfected infants, as documented through the results of a PCR test.
* Born with a birth weight ≥ 2.0 kg
* Informed consent form signed by the parent(s)/legal guardian(s) and by one independent witness if the parent(s)/legal guardian(s) is illiterate
* Participants and parent(s)/legal guardian(s) are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
* Participation in another clinical trial of an investigational product in the 4 weeks preceding the trial inclusion (receipt of study vaccine) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Group A participants diagnosed with a chronic condition, except HIV infection, or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder; and Group B participants diagnosed with chronic illness or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder.
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (oral polio vaccine \[OPV\] given at birth does not constitute an exclusion criteria), hepatitis B (a birth dose of Hep B vaccine does not constitute an exclusion criteria) diseases or Hib infection with the trial vaccine or another vaccine. Previous vaccination with Bacillus Calmette-Guerin (BCG) is not considered an exclusion criterion
* History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
* History of seizures or history of uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Febrile (axillary temperature ≥ 38°C) or acute illness on the day of inclusion (temporary contraindication).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Weeks
Maximum Age:
8 Weeks
Study:
NCT02817451
Study Brief:
Protocol Section:
NCT02817451