Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00197821
First received: September 12, 2005
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.


Condition Intervention Phase
Streptococcus Pneumoniae
Biological: pneumococcal conjugate vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: Completed by dec 2008 ] [ Designated as safety issue: No ]
    ELISA based asssay for serotype specific pneumococcal responses


Enrollment: 611
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: pneumococcal conjugate vaccine
    Pneumococcal conjugate vaccine
  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent for participation in the study; ages between 50 and 80 years at recruitment

Exclusion Criteria:

  • Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
  • Current participation in any other clinical trial
  • Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
  • Prior pneumococcal conjugate vaccine (PNC)
  • 23 valent pneumococcal vaccine(PPV) in last 5 years
  • Severe general or local reaction to a previous dose of PNC or PPV
  • Patients currently immunocompromised as listed in UK Handbook "Immunisation Against Infectious Disease" ed 1996
  • Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study
  • Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook "Immunisation Against Infectious Disease"
  • Deferral of vaccination if acute systemic illness or temperature >38C on day of vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197821

Sponsors and Collaborators
Health Protection Agency, United Kingdom
Investigators
Principal Investigator: Elizabeth Miller, MBBS FRCPath Heath Protection Agency
  More Information

Additional Information:
No publications provided by Health Protection Agency, United Kingdom

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Elizabeth Miller, Consultant epidemiologist, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT00197821     History of Changes
Other Study ID Numbers: PNCA
Study First Received: September 12, 2005
Last Updated: March 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 15, 2014