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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastroenteritis, Rotavirus

Intervention / Treatment
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* Biological: Rotavirus Vaccine, Live, Oral, Pentavalent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RotaTeq™ Vaccine (V260)<br>Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India. | Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* 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.<br>* Other names: V260;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 G1 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 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 IgA |  | 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 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 G4 |  | Baseline and Approximately 6 Months | 
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 |  | Baseline and Approximately 6 Months |