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

Primary Purpose

Rotavirus Gastroenteritis

Status

Completed

Phase

Phase 3

Locations

Vietnam

Study Type

Interventional

Intervention

Rotavac

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria

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.

Exclusion Criteria:

Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
Presence of fever (>37.5C) or hypothermia (<35.5C) 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, 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.

Sites / Locations

Vietnam Military Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm Rotavac

Arm Description

Single arm Open Label study without comparator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess and compare reactogenicity and safety (adverse events)

Reactogenicity and safety of Rotavac in terms of adverse event

Full Information

NCT ID

NCT04596696

First Posted

May 14, 2018

Last Updated

October 21, 2020

Sponsor

Bharat Biotech International Limited

1. Study Identification

Unique Protocol Identification Number

NCT04596696

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

December 20, 2017 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bharat Biotech International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

The study is an open labeled, clinical trial in infants 6-8 weeks of age will be assigned to receive 3 doses of Rotavac® to evaluate the immunogenicity and safety. Active surveillance will be conducted for all participants for 14 & 28 days after each dose of vaccine to obtain information on adverse events. ("Reactogenicity") Childhood vaccines including pentavalent (Diptheria, Tetanus, Pertussis, Hib, Hepatitis B) and oral polio vaccine as well as injectable polio vaccine will be administered along with the study vaccines as per Expanded Program on Immunization (EPI) Safety assessments will include observation in the study clinic for 30 minutes after each vaccine administration to record immediate adverse events. A subject diary card and personal contact with the subjects will be made to record adverse events during the 14-day period following vaccine administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotavirus Gastroenteritis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm Rotavac

Arm Type

Other

Arm Description

Single arm Open Label study without comparator

Intervention Type

Biological

Intervention Name(s)

Rotavac

Intervention Description

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.

Primary Outcome Measure Information:

Title

Demonstrate immunogenicity of 3-dose regimen of Rotavac

Description

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

Time Frame

At the end of 28 days after last dose

Secondary Outcome Measure Information:

Title

Assess and compare reactogenicity and safety (adverse events)

Description

Reactogenicity and safety of Rotavac in terms of adverse event

Time Frame

At the end of 28 days after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. Exclusion Criteria: Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion). Presence of fever (>37.5C) or hypothermia (<35.5C) 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, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Krishana Mohan, MD

Organizational Affiliation

Bharat Biotech International Limited

Official's Role

Study Director

Facility Information:

Facility Name

Vietnam Military Medical University Hospital

City

Hanoi

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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