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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014