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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT01917357
Eligibility Criteria:
Inclusion Criteria:
* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
* Written informed consent obtained from parents/legal guardians of the subject
* Free of obvious health problems as established by medical history and/or clinical examination before entering the study
* HepB vaccination at birth (within 48 hours)
* Available for all scheduled study visits
Exclusion Criteria:
* Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
* Planned administration of a vaccine not foreseen by the Study Protocol
* Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
* Administration of parenteral immunoglobulin preparation and/or blood products since birth
* Previous vaccination against Hib and/or DTP
* History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal
* Clinically significant acute infection
* Clinically significant acute illness
* Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
* Participation in another clinical study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
42 Days
Maximum Age:
64 Days
Study:
NCT01917357
Study Brief:
Protocol Section:
NCT01917357