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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01480258
Eligibility Criteria:
Inclusion Criteria:
* Healthy infant able to attend all study visits
* Parent(s)/legal representative are able to read, understand, and complete study questionnaires
Exclusion Criteria:
* History of congenital or acquired immunodeficiency
* Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
* History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
* Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
* Has any chronic illness that could interfere with study conduct or completion
* Received any immune globulin, blood, or blood-derived products since birth
* Received a dose of hepatitis B vaccine prior to study entry
* Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof
* Fever within 24 hours prior to enrollment
* Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrolment
* Has a coagulation disorder
* Has developmental delay or neurological disorder
* Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity
* History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
46 Days
Maximum Age:
89 Days
Study:
NCT01480258
Study Brief:
Protocol Section:
NCT01480258