Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

Status and phase

Unknown

Phase 3

Conditions

Rotavirus Infections

Treatments

Biological: ROTAVAC®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03367559

VX-2017.01

Details and patient eligibility

About

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 in Vietnam.

Enrollment

360 estimated patients

Sex

All

Ages

6 to 8 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.