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

NCT03367559 | Unknown Phase 3

• 1 other identifier: VX-2017.01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotavirus Infections

Keywords

Rotavirus; ROTAVAC; Vaccine; Vietnam

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Rotavirus Vaccine

EXPERIMENTAL

3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age.

Biological: ROTAVAC®

Interventions

ROTAVAC® BIOLOGICAL

Rotavac® is in frozen form and is thawed till fully liquid prior to administration.

Rotavirus Vaccine

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Thai Binh Health Center

Thái Bình, 410000, Vietnam

Location

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 8, 2017
• Study Start: February 8, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

VN (1)