Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
This study has been withdrawn prior to enrollment.
(Replaced with an alternate study)
Sponsor:
Shantha Biotechnics Limited
Collaborator:
Program for Appropriate Technology in Health
Information provided by:
Shantha Biotechnics Limited
ClinicalTrials.gov Identifier:
NCT00757926
First received: September 22, 2008
Last updated: February 2, 2010
Last verified: February 2010
Tracking Information | |||||
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First Received Date ICMJE | September 22, 2008 | ||||
Last Updated Date | February 2, 2010 | ||||
Start Date ICMJE | September 2009 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Safety and tolerability [ Time Frame: Upto one month after each of the three doses of vaccine/ placebo ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00757926 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants | ||||
Official Title ICMJE | Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines | ||||
Brief Summary | A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Rotavirus Infections | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Estimated Enrollment ICMJE | 240 | ||||
Estimated Completion Date | September 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Weeks to 8 Weeks | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | India | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00757926 | ||||
Other Study ID Numbers ICMJE | SBL/BRV-TV/PhI/2008/0100 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Dr. Raman Rao, Head clinical Research and Medical Affairs, Shantha Biotechnics Limited, Hyderabad | ||||
Study Sponsor ICMJE | Shantha Biotechnics Limited | ||||
Collaborators ICMJE | Program for Appropriate Technology in Health | ||||
Investigators ICMJE |
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Information Provided By | Shantha Biotechnics Limited | ||||
Verification Date | February 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |