Status:
UNKNOWN
A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India
Lead Sponsor:
PATH
Collaborating Sponsors:
Bill and Melinda Gates Foundation
SK Bioscience Co., Ltd.
Conditions:
Rotavirus Infection of Children
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 ...
Eligibility Criteria
Inclusion
- Healthy infants as established by medical history and clinical examination before entering the study
- Age: ≥6 and \<8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old)
- Parental/legal guardian's ability and willingness to provide written informed consent
- Intention of the participants' parents to remain in the area with the child during the study period
Exclusion
- Acute disease at the time of first study vaccination - temporary exclusion
- Presence of fever on the day of first study vaccination (axillary temperature \>37.6oC) - temporary exclusion
- Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw)
- Presence of severe malnutrition (weight-for-height z-score ≤-3SD median, per WHO published child growth standards) 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 that would compromise the participant's health or is likely to result in nonconformance to the protocol
- History of premature birth (\<37 weeks gestation) and/or birth weight of \<2.5 kg
- History of congenital abdominal disorders, intussusception, or abdominal surgery
- Prior receipt of rotavirus vaccine
- Known sensitivity or allergy to any components of the study vaccine
- Contraindication to any EPI/UIP vaccine
- History of anaphylactic reaction
- Major congenital or genetic defect
- Parents not able, available or willing to accept active weekly follow-up by the study staff
- Receipt of any immunoglobulin therapy and/or blood products
- Nursing infants whose mother are receiving immunosuppressive biologicals
- History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on inhaled or topical steroids may be permitted to participate in the study)
- Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents' ability to give informed consent
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
8200 Patients enrolled
Trial Details
Trial ID
NCT04010448
Start Date
October 10 2019
End Date
December 15 2025
Last Update
April 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, Zambia