A Phase III study to Evaluate the Non-interference in the Immune Response of Rotavac to Childhood Vaccines and to Assess the Clinical Lot Consistency.

A Phase III Randomized, Double Blind Placebo Controlled Trial To Evaluate the Non-interference in the Immune Response of Three Doses of ORV 116E to Antigens Contained in Childhood Vaccines and to Assess the Clinical Lot Consistency of Three Production Lots

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/05/004592

Enrollment

1356

Registered

2014-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Oral Rotavirus Vaccine 116E (ORV 116E)of Bharat Biotech International Limited: 3 doses of 0.5mL

to be administered 4 weeks apart Control Intervention1: Placebo: 3 doses of 0.5mL

to be administered 4 weeks apart

Eligibility

Inclusion criteria

Inclusion criteria: 1. At least one parent(s) consent for participation and are able to understand study procedures 2. Subjects aged 6 to 7 weeks (42 to 55 days) at recruitment 3. No plans to move in the next 4-6 months

Exclusion criteria

Exclusion criteria: 1. Has already received the 6-7 week dose of the childhood vaccines 2. Administration of rotavirus vaccine in the past 3. Presence of any illness requiring hospital referral (temporary exclusion) 4. Known case of immunodeficiency disease, known HIV positive 5. Known case of chronic gastroenteritis disease 6. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems â??illâ??, investigators suspects neglect) 7. Diarrhea in the previous 24 hours

Design outcomes

Primary

Measure	Time frame
1. To determine whether ORV 116E, NLT 105.0 ffu can be successfully co-administered with childhood vaccines (Oral Polio Vaccine, Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus influenzae Type B) at 6-7, 10-14 and 14-18 weeks of age, without interfering with the immune responses to each of these vaccines. 2. To determine clinical lot consistency in the immune responses between three different production lots of the ORV 116E.Timepoint: 28 (Â±5) days after the third dose of the Test Article and childhood vaccines.	—

Measure

Time frame

1. To determine whether ORV 116E, NLT 105.0 ffu can be successfully co-administered with childhood vaccines (Oral Polio Vaccine, Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus influenzae Type B) at 6-7, 10-14 and 14-18 weeks of age, without interfering with the immune responses to each of these vaccines. 2. To determine clinical lot consistency in the immune responses between three different production lots of the ORV 116E.Timepoint: 28 (Â±5) days after the third dose of the Test Article and childhood vaccines.

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Secondary

Measure	Time frame
To assess the safety of a 3-dose regimen of ORV 116E, given concomitantly with childhood vaccines 1. for immediate adverse events and serious adverse events 2. for adverse events in the 2-week period following each administration 3. for intussusception events 4. Immunogenicity assessed through a fourfold rise in rotavirus-specific serum IgA antibody titers. Timepoint: Safety: 30 minutes after receipt of vaccines for immediate adverse events, 2 weeks after each vaccination for adverse events, till 4 weeks after the third dose for serious adverse events, throughout the study period for death and intussusception. Immunogenicity: 28 (Â±5) days after the third dose of the Test Article	—

Measure

Time frame

To assess the safety of a 3-dose regimen of ORV 116E, given concomitantly with childhood vaccines 1. for immediate adverse events and serious adverse events 2. for adverse events in the 2-week period following each administration 3. for intussusception events 4. Immunogenicity assessed through a fourfold rise in rotavirus-specific serum IgA antibody titers. Timepoint: Safety: 30 minutes after receipt of vaccines for immediate adverse events, 2 weeks after each vaccination for adverse events, till 4 weeks after the third dose for serious adverse events, throughout the study period for death and intussusception. Immunogenicity: 28 (Â±5) days after the third dose of the Test Article

—

Countries

India

Contacts

Public ContactDr GVJA Harshavardhan

Bharat Biotech International Limited

kmohan@bharatbiotech.com04023480567

Outcome results