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Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007 EXT1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00560950
First received: November 19, 2007
Last updated: February 23, 2012
Last verified: February 2012
History of Changes

November 19, 2007
February 23, 2012
July 2007
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
  • 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 ]
    Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Antibody levels will be measured including change from baseline [ Time Frame: 28 Days ]
Complete list of historical versions of study NCT00560950 on ClinicalTrials.gov Archive Site
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Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007 EXT1)(COMPLETED)
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

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

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pneumococcal Infection
Biological: pneumococcal 23v polysaccharide vaccine
Duration of Treatment: Single vaccination on Day 1
Other Names:
  • V110
  • PNEUMOVAX
  • Experimental: 1st Revaccination Group
    Intervention: Biological: pneumococcal 23v polysaccharide vaccine
  • Experimental: 2nd Revaccination Group
    Intervention: Biological: pneumococcal 23v polysaccharide vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
59 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00560950
2007_540, V110-007
Not Provided
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP