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Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Primary Purpose

Rotavirus Infections, Gastroenteritis

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

About this trial

This is an interventional treatment trial for Rotavirus Infections

Eligibility Criteria

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

Inclusion Criteria: Infants in good health Exclusion Criteria: Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study Any condition resulting in depressed immunity Any allergy to any vaccine component as stated in the package circulars Allergies to polymyxin B, neomycin or any other antibiotics Receipt of intramuscular, oral, or intravenous corticosteroid treatment History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive Prior receipt of a blood transfusion or blood products, including immunoglobulin Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization Infants residing in a household with an immunocompromised person

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    RotaTeq and OPV concomitantly

    RotaTeq and OPV on staggered schedule

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3
    GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
    GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
    GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
    Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered
    Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 12, 2005
    Last Updated
    March 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00130832
    Brief Title
    Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
    Official Title
    Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (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
    The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    735 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    RotaTeq and OPV concomitantly
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    RotaTeq and OPV on staggered schedule
    Intervention Type
    Biological
    Intervention Name(s)
    Rotavirus Vaccine, Live, Oral, Pentavalent
    Intervention Description
    Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Oral Poliovirus Vaccine (OPV)
    Intervention Description
    Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
    Intervention Description
    Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3
    Description
    GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
    Time Frame
    Approximately 42 days Postdose 3
    Title
    GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
    Description
    GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
    Time Frame
    Approximately 42 days Postdose 3
    Title
    Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered
    Description
    Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
    Time Frame
    Approximately 42 days Postdose 3

    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: Infants in good health Exclusion Criteria: Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study Any condition resulting in depressed immunity Any allergy to any vaccine component as stated in the package circulars Allergies to polymyxin B, neomycin or any other antibiotics Receipt of intramuscular, oral, or intravenous corticosteroid treatment History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive Prior receipt of a blood transfusion or blood products, including immunoglobulin Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization Infants residing in a household with an immunocompromised person
    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

    Citations:
    PubMed Identifier
    18756184
    Citation
    Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780.
    Results Reference
    result

    Learn more about this trial

    Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

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