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

This study has been completed.

First Received: September 12, 2005 Last Updated: May 7, 2008 History of Changes

Sponsored by:	Health Protection Agency
Information provided by:	Health Protection Agency
ClinicalTrials.gov Identifier:	NCT00197821

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Health Protection Agency:

Estimated Enrollment:	611
Study Start Date:	January 2004

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

Investigators

Principal Investigator:

Elizabeth Miller, MBBS FRCPath

Heath Protection Agency

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	PNCA
Study First Received:	September 12, 2005
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00197821 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Healthy
Pneumonia

Additional relevant MeSH terms:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on September 03, 2009