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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT01986335
Eligibility Criteria:
Inclusion Criteria:
* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighting more than 2.5 kg at birth
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
* Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
* Mother at least graduate from elementary school
* Received Hepatitis B vaccine (Bio Farma) at birth
Exclusion Criteria:
* Child concomitantly enroll or schedule to be enroll in another trial
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 Celsius on Day 0)
* Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
* History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 weeks)
* Other vaccination within the 1 month prior to inclusion with the exception of BCG and poliomyelitis
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
* Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
11 Weeks
Study:
NCT01986335
Study Brief:
Protocol Section:
NCT01986335