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This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBRV-PV Lot A | Experimental | The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A). |
|
| LBRV-PV Lot B | Experimental | The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B). |
|
| LBRV-PV Lot C | Experimental | The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C). |
|
| ROTASIIL | Active Comparator | The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Rotavirus Vaccine | Biological | Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of rotavirus vaccine | Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL | 28 days post dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Endpoints | GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination. | 28 days post dose 3 |
| Immunogenicity Endpoints | Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal, | Udupi | Karnataka | 576104 | India | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30955982 | Derived | Kawade A, Babji S, Kamath V, Raut A, Kumar CM, Kundu R, Venkatramanan P, Lalwani SK, Bavdekar A, Juvekar S, Dayma G, Patil R, Kulkarni M, Hegde A, Nayak D, Garg BS, Gupta S, Jategaonkar S, Bedi N, Maliye C, Ganguly N, Uttam KG, Niyogi P, Palkar S, Hanumante N, Goyal N, Arya A, Aslam M, Parulekar V, Dharmadhikari A, Gaikwad D, Zade J, Desai S, Kang G, Kulkarni PS. Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine. 2019 May 1;37(19):2554-2560. doi: 10.1016/j.vaccine.2019.03.067. Epub 2019 Apr 4. |
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|
| 28 days post dose 3 |
| KEM Hospital Research Centre |
| Pune |
| Maharashtra |
| 411028 |
| India |
| Bharati Vidyapeeth Medical College and Hospital, Pune | Pune | Maharashtra | 411043 | India |
| Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram | Wardha | Maharashtra | 442102 | India |
| Hakeem Abdul Hameed Centenary Hospital | New Delhi | National Capital Territory of Delhi | India |
| Sri Ramachandra Medical Centre, Chennai | Chennai | Tamil Nadu | 600116 | India |
| Institute of Child Health, Kolkata | Kolkata | West Bengal | 700017 | India |
| Post Graduate Institute of Medical Education and Research, Chandigarh | Chandigarh | 160012 | India |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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