Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00362648 |
Recruitment Status
:
Completed
First Posted
: August 10, 2006
Results First Posted
: May 13, 2010
Last Update Posted
: April 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vomiting Diarrhea Fever | Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7504 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
RotaTeq™
|
Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
2.0 mL oral dose of RotaTeq™. 14 week treatment period
Other Names:
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Placebo Comparator: 2
Placebo
|
Biological: Comparator: Placebo
Arm 2: Placebo. 14 week treatment period
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- 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 ]
- Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 14 days following the 3rd vaccination ]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] [ Time Frame: 14 days following the 3rd vaccination ]Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

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Ages Eligible for Study: | up to 12 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362648
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00362648 History of Changes |
Other Study ID Numbers: |
V260-015 2006_027 |
First Posted: | August 10, 2006 Key Record Dates |
Results First Posted: | May 13, 2010 |
Last Update Posted: | April 13, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
Additional relevant MeSH terms:
Vomiting Diarrhea Signs and Symptoms, Digestive Signs and Symptoms |