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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01231503
Eligibility Criteria:
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
* A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth).
* Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
* Born to a mother negative for HIV antibody and Hepatitis B surface antigen.
* Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life).
* A minimum weight of 2.5 kg.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
* Acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to:
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects.
* History of any neurological disorders or seizures.
* Laboratory screening tests out of normal ranges/limits defined per protocol.
* Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vaccines.
* Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) not foreseen by the study protocol within 7 days of the first dose of study vaccine.
* Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
* Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) other than the study vaccine starting at birth or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Simultaneous participation in any other clinical trial.
* Same-sex twins (to avoid misidentification).
* Maternal death.
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
7 Days
Study:
NCT01231503
Study Brief:
Protocol Section:
NCT01231503