Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Vomiting; Diarrhea; Fever	Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Comparator: Placebo	Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: RotaTeq™; V260
Placebo Comparator: 2; Placebo	Biological: Comparator: Placebo; Arm 2: Placebo. 14 week treatment period

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Measures :

1. 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)
2. 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)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information 

Merck: Patient & Caregiver U.S. Product Web Site 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Schödel 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.

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, Schödel 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.

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
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