Last updated: January 5, 2021
Sponsor: Center for Research and Production of Vaccines and Biologicals, Vietnam
Overall Status: Completed
Phase
3
Condition
Stomach Discomfort
Lactose Intolerance
Colic
Treatment
N/AClinical Study ID
NCT03703336
CVIA 068
VX.2018.05
Ages 60-91 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy infants as established by medical history and clinical examination beforeentering the study.
- Age: 60-91 days (both days inclusive) at the time of enrollment.
- Parental/legally acceptable representative ability and willingness to provide writteninformed consent.
- Parent/legally acceptable representative who intends to remain in the area with thechild during the study period.
Exclusion
Exclusion Criteria:
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- Presence of fever on the day of enrollment (temporary exclusion).
- Acute disease at the time of enrollment (temporary exclusion).
- Concurrent participation in another clinical trial at any point throughout the entiretime frame for this study.
- Presence of significant malnutrition (weight-for-height z-score < -3 SD median)
- 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 / orphysical examination which would compromise the participant's health or is likely toresult in nonconformance to the protocol.
- History of congenital abdominal disorders, intussusception, or abdominal surgery.
- Known or suspected impairment of immunological function based on medical history andphysical examination.
- Household contact with an immunosuppressed individual or pregnant woman.
- Prior receipt of rotavirus or an intent to receive this vaccine from outside of thestudy center during study participation.
- Prior receipt of Expanded Program on Immunization (EPI) vaccination during past 7 daysor plan to receive them within next 7 days.
- A known sensitivity or allergy to any components of the study vaccine.
- History of allergy to antibiotic kanamycin.
- Clinically detectable significant congenital or genetic defect.
- History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
- Receipt of immunoglobulin therapy and / or blood products since birth or plannedadministration during the study period.
- History of chronic administration (defined as more than 14 days) of immunosuppressantsincluding corticosteroids. Infants on inhaled or topical steroids may be permitted toparticipate in the study.
- Any medical condition in the parent/legally acceptable representative or infant which,in the judgment of the Investigator, would interfere with or serves as acontraindication to protocol adherence.
Study Design
Total Participants: 825
Study Start date:
March 16, 2019
Estimated Completion Date:
January 08, 2020
Study Description
Connect with a study center
CDC Nam Dinh
Nam Dinh, 10000
VietnamSite Not Available
CDC Quang Ninh
Quang Ninh, 10000
VietnamSite Not Available
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