Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 110
- Primary Endpoint
- The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Time Frame: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Time Frame: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Time Frame: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Time Frame: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Time Frame: Baseline and Approximately 6 Months
Secondary Outcomes
No secondary outcomes reported