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

An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam

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.

Study Overview

• Status: Unknown
• Conditions: Rotavirus Infections
• Intervention / Treatment: Biological: ROTAVAC®

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Thái Bình, Vietnam, 410000
    • Thai Binh Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotavirus Vaccine; 3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age.	Biological: ROTAVAC®; Rotavac® is in frozen form and is thawed till fully liquid prior to administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and rate of the AEs within 30 minutes after vaccination	Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination	30 minutes after vaccination
Frequency and rate of the AEs within 7 days after vaccination	Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination	for 7 days after each vaccination
Frequency and rate of the AEs during 28 days after vaccination	Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination	for 28 days after vaccination
Frequency and rate of the SAEs during 28 days after vaccination	Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination	for 28 days after vaccination

Collaborators and Investigators

• Sponsor: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
• Collaborators: Bharat Biotech International Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Vaccine; Vietnam; Rotavirus; ROTAVAC
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: VX-2017.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No