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

Phase 3

Completed

• Conditions: Gastroenteritis; Rotavirus
• Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

• Registration Number: NCT00496054
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2008-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-11-12
• Results First Submitted QC: 2010-02-17
• Results First Posted: 2010-03-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Age 6 weeks through exactly 12 weeks
• Healthy infants

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RotaTeq™ Vaccine (V260)	Rotavirus Vaccine, Live, Oral, Pentavalent	Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.

Primary Outcome Measures

Name	Time	Method
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA	Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)	Baseline and Approximately 6 Months
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA	Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)	Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)	Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)	Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)	Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)	Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1	Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4	Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2	Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3	Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1	Baseline and Approximately 6 Months