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Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

Primary Purpose

Vaccines, Pneumococcal, Infant, Fever, Chemically Induced

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prevenar
Infanrix hexa
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccines, Pneumococcal focused on measuring vaccine, infant

Eligibility Criteria

56 Days - 112 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy infants age 55 to 112 days Subject's parents/legal guardians provide written informed consent Exclusion Criteria: Prematurely born subjects < 37 weeks gestation Known or suspected disease of immune system Known or suspected hypersensitivity to any vaccine or vaccine component

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4

    Secondary Outcome Measures

    Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4

    Full Information

    First Posted
    February 17, 2006
    Last Updated
    February 20, 2013
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00294294
    Brief Title
    Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
    Official Title
    A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix Hexa®) in Children at 2, 3, 4 and 11-14 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaccines, Pneumococcal, Infant, Fever, Chemically Induced, Drug Therapy, Combination
    Keywords
    vaccine, infant

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Prevenar
    Intervention Type
    Biological
    Intervention Name(s)
    Infanrix hexa
    Primary Outcome Measure Information:
    Title
    Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
    Secondary Outcome Measure Information:
    Title
    Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    56 Days
    Maximum Age & Unit of Time
    112 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy infants age 55 to 112 days Subject's parents/legal guardians provide written informed consent Exclusion Criteria: Prematurely born subjects < 37 weeks gestation Known or suspected disease of immune system Known or suspected hypersensitivity to any vaccine or vaccine component
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23786774
    Citation
    Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine. BMC Pediatr. 2013 Jun 21;13:98. doi: 10.1186/1471-2431-13-98.
    Results Reference
    derived

    Learn more about this trial

    Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

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