Clincosm LogoSign in Get a demo

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

Sponsor
Public Health England (Other)
Overall Status
Completed
CT.gov ID
NCT00197769
Collaborator
(none)
40
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: 9 valent pneumococcal con jugate vaccine
 Phase 2

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date :
Sep 1, 2000
Study Completion Date :
Jan 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Weeks to 18 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Public Health England

    Investigators

    • Principal Investigator: Elizabeth Miller, MBBS FRCPath, Public Health England

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00197769
    Other Study ID Numbers:
    • PNC1/2
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Aug 29, 2018
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:
    Pneumonia, Pneumococcal

    Study Results

    No Results Posted as of Aug 29, 2018