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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
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:

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 ]
    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.


Enrollment: 143
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1st Revaccination Group Biological: pneumococcal 23v polysaccharide vaccine
Duration of Treatment: Single vaccination on Day 1
Other Names:
  • V110
  • PNEUMOVAX
Experimental: 2nd Revaccination Group Biological: pneumococcal 23v polysaccharide vaccine
Duration of Treatment: Single vaccination on Day 1
Other Names:
  • V110
  • PNEUMOVAX

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
ClinicalTrials.gov Identifier: NCT00560950     History of Changes
Other Study ID Numbers: 2007_540, V110-007
Study First Received: November 19, 2007
Results First Received: March 30, 2009
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 18, 2013