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RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Primary Purpose

Meningitis, Meningococcal, Rotavirus Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RotaTeq®
NeisVac-C®
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.

Eligibility Criteria

42 Days - 55 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants, aged from 6 weeks through full 7 weeks,
  • Consent form signed by at least one parent or by the legal representative properly informed about the study,
  • Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

  • History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
  • Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
  • Known or suspected impairment of immunological function,
  • Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
  • Prior administration of any rotavirus vaccine,
  • Prior administration of any vaccine within the 28 days prior to randomisation,
  • Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
  • History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
  • Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
  • Clinical evidence of active gastrointestinal illness,
  • Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
  • Infants residing in a household with an immunocompromised person,
  • Prior receipt of a blood transfusion or blood products, including immunoglobulins.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group 1: Concomitant Administration

    Group 2: Sequential Administration

    Arm Description

    Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age).

    Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
    Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 5, 2007
    Last Updated
    September 8, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00443846
    Brief Title
    RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
    Official Title
    An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 13, 2007 (Actual)
    Primary Completion Date
    September 4, 2007 (Actual)
    Study Completion Date
    October 23, 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meningitis, Meningococcal, Rotavirus Infections
    Keywords
    Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: Concomitant Administration
    Arm Type
    Experimental
    Arm Description
    Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age).
    Arm Title
    Group 2: Sequential Administration
    Arm Type
    Active Comparator
    Arm Description
    Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
    Intervention Type
    Biological
    Intervention Name(s)
    RotaTeq®
    Other Intervention Name(s)
    V260
    Intervention Description
    Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
    Intervention Type
    Biological
    Intervention Name(s)
    NeisVac-C®
    Intervention Description
    Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
    Description
    Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.
    Time Frame
    28 days after the second dose of MCC vaccine (approximately 20 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    42 Days
    Maximum Age & Unit of Time
    55 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy infants, aged from 6 weeks through full 7 weeks, Consent form signed by at least one parent or by the legal representative properly informed about the study, Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card. Exclusion Criteria: History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery, Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, Known or suspected impairment of immunological function, Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid), Prior administration of any rotavirus vaccine, Prior administration of any vaccine within the 28 days prior to randomisation, Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation, History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive, Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, Clinical evidence of active gastrointestinal illness, Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study, Infants residing in a household with an immunocompromised person, Prior receipt of a blood transfusion or blood products, including immunoglobulins.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21389149
    Citation
    Vesikari T, Karvonen A, Borrow R, Kitchin N, Baudin M, Thomas S, Fiquet A. Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine. Clin Vaccine Immunol. 2011 May;18(5):878-84. doi: 10.1128/CVI.00437-10. Epub 2011 Mar 9.
    Results Reference
    derived

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    RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

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