A study to evaluate immune non-inferiority and safety of Tetravalent Rotavirus Vaccine (BRV-TV) in comparison to licensed vaccine (RotaTeq) in healthy infants.

Phase 3

Completed

• Registration Number: CTRI/2014/08/004893
• Lead Sponsor: Shantha Biotechnics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1182

Inclusion Criteria

All infants must fulfill all of the following criteria in order to be eligible for the trial enrollment

• Healthy infants, of either sex, 6-8 weeks of age at time of enrollment;

• Born after a gestational period of >=36 weeks with birth weight >= 2 kg;

• Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having the ICF explained to them in the presence of an impartial witness and the witness having signed the ICF.

• Infant, parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria

Any infant fulfilling any of the following criteria is to be excluded from the trial enrollment

• History of congenital abdominal disorders, intussusception, or abdominal surgery;

• Infants exhibiting signs of severe malnutrition;

• Known or suspected impairment of immunological function in subject or immediate family;

• Developmental delay or Neurological disorder;

• Known hypersensitivity to any component of the study vaccines or any history of allergic reaction in past;

• Prior receipt of any rotavirus vaccine;

• Prior receipt of any dose of Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib or polio virus containing vaccine(s). Birth dose of Hepatitis B,BCG and Oral Polio Vaccine is allowed to be administered to the infants as per the local immunization practices. Oral Polio Vaccines administered as a part of the National Pulse Polio Program are allowed to be administered to the infants.

• History of known rotavirus disease, chronic diarrhea, or failure to thrive;

• Clinical evidence of active gastrointestinal illness including ongoing diarrheal episode (infants with GERD can participate in the study as long as the condition is well controlled with or without medication);

• Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study);

• Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkinâ??s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);

• Infants already laboratory confirmed or suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV, or HCV positive (no specific screening for the purpose of the study would be carried out);

• Prior receipt of a blood transfusion or blood products, including immunoglobulins, in the past 4 weeks which might interfere with the assessment of the immune response;

• Any infants who cannot be adequately followed for safety by a home visit;

• Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;

• Parent/s or guardian of infant unable to maintain symptom diary or note the AEs and temperature in native language for subsequent transfer into symptom diary with help of the site study team;

• Participation in another clinical trial investigating a vaccine, drug, medical device or medicinal procedure in the 4 weeks preceding the trial vaccination;

• Planned participation in another clinical trial during the present trial period;

• Parents/ Guardians/ Legally Accepted Representatives identified as employees of the investigator, with direct involvement in the proposed study or studies under the direction of that investigator as well as children, adopted or natural, of the employees or Investigator.

• Parents/ Guardians/ Legally Accepted Representatives unwilling to provide consent for Audio Visual recording of the informed consent process.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sero-response rate of Investigational Rotavirus vaccine/ RotaTeqTimepoint: 28 days post 3rd dose of vaccination

Secondary Outcome Measures

Name	Time	Method
â?¢ Frequency, severity, and causality of REs and other AEs following the dose of Investigational Rotavirus Vaccine /RotaTeq. <br/ ><br>â?¢ Describe the serum anti-rotavirus neutralizing antibody titres of BRV-TV/RotaTeq <br/ ><br>â?¢ Demonstrate the non-inferiority of the seroprotection/ seroresponse levels of the Ig antibodies against Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib, and Polio vaccine when co-administered with BRV-TV versus when co-administered with RotaTeq <br/ ><br>Timepoint: â?¢ Till 28 days post vaccination <br/ ><br>â?¢ 28 days post 3rd dose of vaccination <br/ ><br>â?¢ 28 days post 3rd dose of vaccination