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Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants

Primary Purpose

Streptococcus Pneumoniae

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
9 valent pneumococcal con jugate vaccine
Sponsored by
Public Health England
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcus Pneumoniae

Eligibility Criteria

7 Weeks - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Informed consent by parent/guardian for receipt of study vaccines and for blood samples Age at first dose: Infants 7-11 weeks; toddlers 12-18 months Exclusion Criteria: Previous bacteriologically confirmed pneumococcal or meningococcal disease Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996. Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study Children participating in any other clinical trial Immunocompromised Acute systemic illness or fever > 38C on day of vaccination - deferral

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    August 28, 2018
    Sponsor
    Public Health England
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00197769
    Brief Title
    Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Public Health England

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers
    Detailed Description
    A new vaccine against pneumococcal infection is now available in the UK and has already been in routine use in the US for five years. The purpose of the trial is to determine the minimum number of does required to protect UK infants and toddlers, and to assess the compatibility of the pneumococcal vaccine with the other vaccines given in the UK childhood immunisation programme. The vaccine used in the US protects against seven strains of pnemococcus whereas the vaccine used in this trial protects against nine strains. Infants received either two doses at two and four months or three doses at two, three and four months of age, the latter comprising the routine infant schedule for other paediatric vaccines in the UK. The infants also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and Hib together with meningitis C vaccine which is currently only used in the UK and a few other countries worldwide. A group of toddlers aged twelve to fifteen months also took apart and received either one or two doses of pneumococcal vaccine around the same time as their MMR vaccine. All children in the study received a booster dose some months later. The response to the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal strains in blood samples taken at various times during the immunisation schedule.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Streptococcus Pneumoniae

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    9 valent pneumococcal con jugate vaccine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Weeks
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Informed consent by parent/guardian for receipt of study vaccines and for blood samples Age at first dose: Infants 7-11 weeks; toddlers 12-18 months Exclusion Criteria: Previous bacteriologically confirmed pneumococcal or meningococcal disease Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996. Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study Children participating in any other clinical trial Immunocompromised Acute systemic illness or fever > 38C on day of vaccination - deferral
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth Miller, MBBS FRCPath
    Organizational Affiliation
    Public Health England
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16567982
    Citation
    Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.
    Results Reference
    result

    Learn more about this trial

    Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants

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