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

Diarrhea Clinical Trial

Official title:

Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362648
• Other study ID #: V260-015
• Secondary ID: 2006_027
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: October 8, 2015
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7504
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Fever
• Vomiting

Intervention

Biological:
• RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
2.0 mL oral dose of RotaTeq™. 14 week treatment period
• Comparator: Placebo
Arm 2: Placebo. 14 week treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose		At least 14 days following the third vaccination	No
Secondary	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)	14 days following the 3rd vaccination	Yes
Secondary	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)	14 days following the 3rd vaccination	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site