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| Name | Class |
|---|---|
| PATH | OTHER |
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This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - BRV-PV Lot A | Experimental | BRV-PV Lot A + DPT- HepB-Hib + OPV |
|
| Group 2 - BRV-PV Lot B | Experimental | BRV-PV Lot B+ DPT- HepB-Hib + OPV |
|
| Group 3 - BRV-PV Lot C | Experimental | BRV-PV Lot C + DPT- HepB-Hib + OPV |
|
| Group 4 - ROTARIX | Active Comparator | ROTARIX + DPT-HepB-Hib + OPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRV-PV Lot A + DPT-HepB-Hib + OPV | Biological | Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rotavirus vaccine lots Immunogenicity | Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots. | Four weeks after the third dose of vaccination |
| Immunogenicity of UIP vaccines | Four weeks after the third dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate adverse events and Solicited post -vaccination reactogenicity | AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination | |
| Rotavirus Immunogenicity: | Serum anti- rotavirus IgA antibody concentrations expressed as GMCs and proportion of subjects with post-vaccination IgA antibody concentration ≥20 U/ml for the comparison of BRV-PV vaccine and licensed rotavirus vaccine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Prasad Kulkarni, M.D. | Serum Institute of India Pvt. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gandhi Medical College and Gandhi Hospital | Hyderabad | Andhra Pradesh | 500020 | India | ||
| King George Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30104114 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| BRV-PV Lot B + DPT-HepB-Hib + OPV | Biological | Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week |
|
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| BRV-PV Lot C + DPT-HepB-Hib + OPV | Biological | Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week |
|
| ROTARIX + DPT-HepB-Hib + OPV | Biological | Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo) |
|
| Four weeks after the third dose of vaccination |
| Visakhapatnam |
| Andhra Pradesh |
| 530002 |
| India |
| JSS Medical College and Hospital | Mysore | Karnataka | 570004 | India |
| T. N. Medical College and B. Y. L. Nair Charitable | Mumbai | Maharashtra | 400008 | India |
| Seth G S Medical College & KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| Bharati Vidyapeeth Medical College and Hospital | Pune | Maharashtra | 411043 | India |
| KEM Hospital and Research Centre, Vadu | Pune | Maharashtra | 412216 | India |
| Sri Ramachandra Medical Centre | Chennai | Tamil Nadu | 600116 | India |
| Institute of Child Health | Kolkata | West Bengal | 700017 | India |
| Maulana Azad Medical College | New Delhi | India |
| ID | Term |
|---|---|
| D011055 | Poliovirus Vaccine, Oral |
| C492457 | RIX4414 vaccine |
| ID | Term |
|---|---|
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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