Revaccination With PNEUMOVAX(TM) 23 in Older Adults - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00560950

Purpose

The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

Condition	Intervention	Phase
Pneumococcal Infection	Biological: pneumococcal 23v polysaccharide vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Multicenter, Open-Label Study of the Safety, Tolerability, and Immunogenicity of Revaccination With PNEUMOVAX(TM) 23 Vaccine (Pneumococcal Vaccine Polyvalent, Merck & Co., Inc.) in Older Adults

Resource links provided by NLM:

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4 [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8 [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14 [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F [ Time Frame: Day 1 & Day 30 ] [ Designated as safety issue: No ]

Enrollment:	400
Study Start Date:	July 2007
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 28 Days

Detailed Description:

This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.

Eligibility

Ages Eligible for Study:	59 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Postmenopausal or negative urine pregnancy test if female
No fever on the day of vaccination

Exclusion Criteria:

History of allergy to vaccine components
History of pneumococcal disease
Received any live virus vaccination within 4 weeks prior to study start
Received any inactivated vaccination within 7 days prior to study start
Received any blood products within 5 months prior to study start
Participated in an investigational drug or vaccine study in the past 30 days
Received immunosuppressive therapy
Patient has an immune deficiency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560950

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_540, V110-007
Study First Received:	November 19, 2007
Results First Received:	March 30, 2009
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00560950 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Pneumococcal Infections

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Infection
Pneumococcal Infections

ClinicalTrials.gov processed this record on September 11, 2009