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

Purpose

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Resource links provided by NLM:

Drug Information available for: Rotavirus vaccine, live, oral, pentavalent

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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] [ Time Frame: 14 days following the 3rd vaccination ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)


Enrollment:	7504
Study Start Date:	March 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	up to 12 Weeks
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362648

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided by Merck Sharp & Dohme Corp.

Additional 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
Study First Received:	August 8, 2006
Results First Received:	March 11, 2010
Last Updated:	November 3, 2014
Health Authority:	Ghana: Ministry of Health

ClinicalTrials.gov processed this record on March 02, 2015