Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

NCT04596696 | Completed Phase 3

• 1 other identifier: BBIL/ROTAVAC/Vietnam/2017
• 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 Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Demonstrate immunogenicity of 3-dose regimen of Rotavac

  Immunogenicity of 3-dose regimen of Rotavac with respect to geometric mean titres (GMT) of serum anti-rotavirus IgA at baseline and post-vaccination 4-6 weeks after third dose

  At the end of 28 days after last dose

Secondary Outcomes (1)

• Assess and compare reactogenicity and safety (adverse events)

  At the end of 28 days after last dose

Study Arms (1)

Single arm Rotavac

OTHER

Single arm Open Label study without comparator

Biological: Rotavac

Interventions

Rotavac BIOLOGICAL

Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P\[11\], containing one bovine rotavirus gene P\[11\] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.

Single arm Rotavac

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
• Age: 6-8 weeks
• Weight ≥2.5kgs at birth
• Infants receiving EPI vaccines as per Vietnam immunization program
• 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, haematological, endocrine, immuno-logical, 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 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 vaccines.
• 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 immunosuppressant 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

• Bharat Biotech International Limited: lead

Study Sites (1)

Vietnam Military Medical University Hospital

Hanoi, Vietnam

Location

Study Officials

• Dr Krishana Mohan, MD

  Bharat Biotech International Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: October 22, 2020
• Study Start: December 20, 2017
• Primary Completion: December 30, 2018
• Study Completion: June 30, 2019
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)