Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
NCT ID: NCT02584816
Last Updated: 2018-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1500 participants
INTERVENTIONAL
2015-11-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1 - BRV-PV Lot A
BRV-PV Lot A + DPT- HepB-Hib + OPV
BRV-PV Lot A + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Group 2 - BRV-PV Lot B
BRV-PV Lot B+ DPT- HepB-Hib + OPV
BRV-PV Lot B + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Group 3 - BRV-PV Lot C
BRV-PV Lot C + DPT- HepB-Hib + OPV
BRV-PV Lot C + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Group 4 - ROTARIX
ROTARIX + DPT-HepB-Hib + OPV
ROTARIX + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
Interventions
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BRV-PV Lot A + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BRV-PV Lot B + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BRV-PV Lot C + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
ROTARIX + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age: 6-8 weeks at the time of enrollment.
3. Parental ability and willingness to provide written informed consent.
4. Parent who intends to remain in the area with the child during the study period.
5. Receipt of birth dose of Hepatitis B vaccine and OPV.
Exclusion Criteria
2. Presence of fever on the day of enrollment (temporary exclusion).
3. Acute disease at the time of enrollment (temporary exclusion).
4. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
5. Presence of significant malnutrition or any systemic disorder as determined by medical history and / or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol.
6. History of congenital abdominal disorders, intussusception, or abdominal surgery.
7. Known or suspected impairment of immunological function based on medical history and physical examination.
8. Household contact with an immunosuppressed individual or pregnant woman.
9. Prior receipt or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
10. A known sensitivity or allergy to any components of the study vaccine.
11. Clinically detectable congenital or genetic defect.
12. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
13. Receipt of any immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
14. 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.
15. History of any neurologic disorders or seizures.
16. Any medical condition in the parents / infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give written informed consent.
6 Weeks
8 Weeks
ALL
Yes
Sponsors
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PATH
OTHER
Serum Institute of India Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Prasad Kulkarni, M.D.
Role: STUDY_DIRECTOR
Serum Institute of India Pvt. Ltd.
Locations
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Gandhi Medical College and Gandhi Hospital
Hyderabad, Andhra Pradesh, India
King George Hospital
Visakhapatnam, Andhra Pradesh, India
JSS Medical College and Hospital
Mysore, Karnataka, India
T. N. Medical College and B. Y. L. Nair Charitable
Mumbai, Maharashtra, India
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, India
Bharati Vidyapeeth Medical College and Hospital
Pune, Maharashtra, India
KEM Hospital and Research Centre, Vadu
Pune, Maharashtra, India
Sri Ramachandra Medical Centre
Chennai, Tamil Nadu, India
Institute of Child Health
Kolkata, West Bengal, India
Maulana Azad Medical College
New Delhi, , India
Countries
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References
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Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL(R) with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10.
Related Links
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Related Info
Other Identifiers
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ROTA: 04 / VAC-020
Identifier Type: -
Identifier Source: org_study_id
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