Official Title: “Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India”

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Biological: rotavirus vaccine, live, oral, pentavalent
  • Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.

Primary Measures

• The proportion of subjects who exhibit a 3 fold rise or greater from baseline to postdose 3 in rotavirus specific serum in iga will be summarized.
  • Time Frame: Approximately 110 Days
    Safety Issue?: No
• The 3 fold rise responses to g1, g2, g3, g4 & p1 serum neutralizing antibodies(sna) will also be summarized. gmt at predose 1 & postdose 3 will also be summarized for all assays
  • Time Frame: Approximately 110 Days
    Safety Issue?: No

Inclusion Criteria:

• Age 6 weeks through exactly 12 weeks
• Healthy infants

Exclusion Criteria:

• Clinical evidence of active gastrointestinal illness
• Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
• History of congenital abdominal disorders, intussusception, or abdominal surgery
• History of known prior rotavirus disease
• Known or suspected impairment of immunological function
• Ongoing chronic diarrhea or failure to thrive
• Prior administration of any rotavirus vaccine
• Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Weeks

Maximum Age for this Clinical Trial: 12 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00496054

Study ID Number: 2007_020

ClinicalTrials.gov Identifier: NCT00496054

Health Authority: India: Indian Council of Medical Research

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

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