Status:
UNKNOWN
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
Lead Sponsor:
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Collaborating Sponsors:
Bharat Biotech International Limited
Conditions:
Rotavirus Infections
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks i...
Eligibility Criteria
Inclusion
- Healthy infants as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks
- Weight ≥ 2.5kg at birth.
- Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
- Parental ability and willingness to provide informed consent.
- Parent who intends to remain in the area with the participant during the study period.
Exclusion
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- Presence of fever (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) on the day of enrollment (temporary exclusion).
- Concurrent participation in another clinical trial.
- Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant's health or is likely to result in non-conformance to the protocol.
- History of congenital abdominal disorders, intussusception, abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Prior receipt of rotavirus vaccine.
- A known sensitivity or allergy to any components of the study medication.
- Major congenital or genetic defect.
- Participant's parents not able, available or willing to accept active follow-up by the study staff.
- Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- History of any neurologic disorders or seizures.
- Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03367559
Start Date
February 8 2018
End Date
May 1 2019
Last Update
March 25 2019
Active Locations (1)
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1
Thai Binh Health Center
Thái Bình, Vietnam, 410000