Status:
COMPLETED
Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine
Lead Sponsor:
PATH
Collaborating Sponsors:
SK Bioscience Co., Ltd.
Murdoch Childrens Research Institute
Conditions:
Rotavirus Vaccine
Eligibility:
All Genders
Up to 56 years
Phase:
PHASE2
Brief Summary
The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost mode...
Detailed Description
This is a phase II, observer-blinded, multi-center, randomized and active-controlled study enrolling healthy infants 0-6 days of age or 6-8 weeks of age. The study will enroll infants in six arms divi...
Eligibility Criteria
Inclusion
- Healthy male and female infants as established by medical history and clinical examination at enrollment.
- Age: ≤ 6 days old (Cohort A) or between the age of 6-8 weeks (42-56 days; inclusive) (Cohort B)
- Birth weight of ≥ 2500 grams.
- Parent's/legally acceptable representative's (LAR) ability and willingness to provide informed consent.
- Parent/LAR confirms intention to stay in the area and bring their infant for the required study visits.
Exclusion
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment; temporary exclusion.
- Presence of acute disease at the time of enrollment; temporary exclusion.
- Presence of fever on the day of enrollment (axillary temperature ≥37.5 °C); temporary exclusion.
- Concurrent participation in another clinical trial throughout the entire timeframe of this study.
- Presence of 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 child's health or is likely to result in non-conformance to the protocol.
- History of premature birth (\<37 weeks gestation) as per the investigator's assessment.
- 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 or intent to receive age specified EPI vaccines including rotavirus vaccine, outside of the study center and during study participation.
- A known sensitivity or allergy to any components of the study medication.
- Clinically detectable congenital anomaly or genetic defect.
- History of persistent diarrhea (defined as diarrhea more than 14 days). Not applicable for selection of Cohort A.
- Participant's parent/LAR not able, available or willing to accept active follow-up by the study staff.
- Receipt of 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 high doses of immunosuppressant including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. Not applicable for selection of Cohort A.
- 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/LAR's ability to give informed consent.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT04344054
Start Date
February 22 2021
End Date
September 9 2022
Last Update
November 29 2022
Active Locations (2)
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1
Wits RHI Shandukani Research Centre
Johannesburg, Gauteng, South Africa, 2003
2
Vaccine and Infectious Diseases Analytics (VIDA) - formerly known as Respiratory and Meningococcal Pathogens Research Unit (RMPRU)
Johannesburg, Gauteng, South Africa, 2013