To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus

NCT04819412 | Completed Phase 3 DMC

• 1 other identifier: BBIL/ROTA5C/III/2014
• Study Type: interventional
• Target: 1,975
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.

• The advantages of the liquid vaccines are: Liquid vaccines take lesser time to administer compared to the current practice of giving antacid buffer prior to vaccine which takes 40% more time to administer.
• Easier to transport as it is stable at 2-80C compared to the frozen formulation that needs to be stored at -200C and transported in dry ice.
• Chances of human error during administration are lesser than the sequential administration of antacid and vaccine.

Conditions

Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• To evaluate the immunogenicity in terms of GMT and four-fold seroconversion

  Immunogenicity

  from Baseline 84 days.

Secondary Outcomes (2)

• Occurrence of adverse events and Serious Adverse events

  from base line to 84 days

• Evaluation of shedding of rotavirus.

  Stool specimen: Day 3 and 7 after each vaccine dose

Study Arms (3)

ROTAVAC 5C -F1

EXPERIMENTAL

ROTAVAC 5C formulation BBIL-R2014-1

Biological: ROTAVAC 5C -F1

ROTAVAC 5C -F2

EXPERIMENTAL

ROTAVAC5C formulation BBIL-R2014-2

Biological: ROTAVAC 5C -F2

ROTAVAC®

ACTIVE COMPARATOR

ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer

Biological: ROTAVAC®

Interventions

ROTAVAC® BIOLOGICAL

ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer

ROTAVAC®

ROTAVAC 5C -F1 BIOLOGICAL

ROTAVAC 5C formulation BBIL-R2014-1

ROTAVAC 5C -F1

ROTAVAC 5C -F2 BIOLOGICAL

ROTAVAC 5C formulation BBIL-R2014-2

ROTAVAC 5C -F2

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 ≥2.5 kgs at birth.
• Infants received EPI vaccines (OPV, BCG and Hep B) at birth.
• 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.
• Household contact with an immunosuppressed individual or pregnant woman.
• Prior receipt of rotavirus vaccine.
• A known sensitivity or allergy to any components of the study vaccines.
• Major congenital or genetic defect.
• History of persistent diarrhoea (defined as diarrhoea more than 14 days).
• 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.
• 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

• Bharat Biotech International Limited: lead
• Georgia Institute for Clinical Research, LLC: collaborator

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: March 29, 2021
• Study Start: March 20, 2015
• Primary Completion: October 30, 2015
• Study Completion: December 30, 2016
• Last Updated: March 29, 2021

Record last verified: 2021-03