Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

Merck Sharp & Dohme LLC110 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

110

Conditions

Gastroenteritis Rotavirus

Interventions

Rotavirus Vaccine, Live, Oral, PentavalentBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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 * Prior administration of any rotavirus vaccine * Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin

Outcomes

Primary Outcomes

The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA