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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

pneumococcal conjugate vaccine

About this trial

This is an interventional prevention trial for Streptococcus Pneumoniae

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Immunogenicity

ELISA based asssay for serotype specific pneumococcal responses

Secondary Outcome Measures

Full Information

NCT ID

NCT00197821

First Posted

September 12, 2005

Last Updated

March 27, 2012

Sponsor

Public Health England

1. Study Identification

Unique Protocol Identification Number

NCT00197821

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Public Health England

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Streptococcus Pneumoniae

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

611 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

pneumococcal conjugate vaccine

Intervention Description

Pneumococcal conjugate vaccine

Primary Outcome Measure Information:

Title

Immunogenicity

Description

ELISA based asssay for serotype specific pneumococcal responses

Time Frame

Completed by dec 2008

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Miller, MBBS FRCPath

Organizational Affiliation

Heath Protection Agency

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19814624

Citation

Goldblatt D, Southern J, Andrews N, Ashton L, Burbidge P, Woodgate S, Pebody R, Miller E. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. 2009 Nov 1;49(9):1318-25. doi: 10.1086/606046.

Results Reference

derived

Links:

URL

http://www.hpa.org.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1203008863939?p=1203008863939

Description

Related Info

Streptococcus Pneumoniae

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial