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

Primary Purpose

Gastroenteritis, Rotavirus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rotavirus Vaccine, Live, Oral, Pentavalent
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroenteritis

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    RotaTeq™ Vaccine (V260)

    Arm Description

    Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 3, 2007
    Last Updated
    March 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00496054
    Brief Title
    Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
    Official Title
    Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroenteritis, Rotavirus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RotaTeq™ Vaccine (V260)
    Arm Type
    Experimental
    Arm Description
    Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.
    Intervention Type
    Biological
    Intervention Name(s)
    Rotavirus Vaccine, Live, Oral, Pentavalent
    Other Intervention Name(s)
    RotaTeq™ Vaccine, V260
    Intervention Description
    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 Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
    Time Frame
    Baseline and Approximately 6 Months
    Title
    The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
    Time Frame
    Baseline and Approximately 6 Months
    Title
    The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
    Time Frame
    Baseline and Approximately 6 Months
    Title
    The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
    Time Frame
    Baseline and Approximately 6 Months
    Title
    The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
    Time Frame
    Baseline and Approximately 6 Months
    Title
    The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
    Time Frame
    Baseline and Approximately 6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    12 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23442588
    Citation
    Lokeshwar MR, Bhave S, Gupta A, Goyal VK, Walia A. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Hum Vaccin Immunother. 2013 Jan;9(1):172-6. doi: 10.4161/hv.22341.
    Results Reference
    derived

    Learn more about this trial

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

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