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

March 27, 2012 updated by: Dr. Elizabeth Miller, Public Health England
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

611

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: Completed by dec 2008
ELISA based asssay for serotype specific pneumococcal responses
Completed by dec 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health England

Investigators

  • Principal Investigator: Elizabeth Miller, MBBS FRCPath, Heath Protection Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 28, 2012

Last Update Submitted That Met QC Criteria

March 27, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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