Back to resultsDeveloping World Study for RotaTeq™ (V260-015)(COMPLETED)
Primary Purpose
Vomiting, Diarrhea, Fever
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
Comparator: Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Vomiting
Eligibility Criteria
Inclusion Criteria: Age 4 weeks through 12 weeks at Dose 1 Parent able to understand study procedures and give consent Exclusion Criteria: Clinical evidence of active gastrointestinal disease Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
RotaTeq™
Placebo
Outcomes
Primary Outcome Measures
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
Secondary Outcome Measures
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00362648
Brief Title
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Official Title
Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Diarrhea, Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7504 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
RotaTeq™
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
Other Intervention Name(s)
RotaTeq™, V260
Intervention Description
2.0 mL oral dose of RotaTeq™. 14 week treatment period
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo
Intervention Description
Arm 2: Placebo. 14 week treatment period
Primary Outcome Measure Information:
Title
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
Time Frame
At least 14 days following the third vaccination
Secondary Outcome Measure Information:
Title
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Description
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Time Frame
14 days following the 3rd vaccination
Title
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Description
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Time Frame
14 days following the 3rd vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 4 weeks through 12 weeks at Dose 1
Parent able to understand study procedures and give consent
Exclusion Criteria:
Clinical evidence of active gastrointestinal disease
Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
29564996
Citation
Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect. 2018 Apr;146(6):698-704. doi: 10.1017/S0950268818000626. Epub 2018 Mar 22.
Results Reference
derived
PubMed Identifier
27755463
Citation
Gruber JF, Hille DA, Liu GF, Kaplan SS, Nelson M, Goveia MG, Mast TC. Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries. Pediatr Infect Dis J. 2017 Jan;36(1):72-78. doi: 10.1097/INF.0000000000001362.
Results Reference
derived
PubMed Identifier
20692031
Citation
Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. doi: 10.1016/S0140-6736(10)60755-6. Epub 2010 Aug 6.
Results Reference
derived
PubMed Identifier
20692030
Citation
Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. doi: 10.1016/S0140-6736(10)60889-6. Epub 2010 Aug 6.
Results Reference
derived
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Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
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