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

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ClinicalTrials.gov Identifier: NCT00560950
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : May 25, 2009
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pneumococcal Infection Biological: pneumococcal 23v polysaccharide vaccine Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]

    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.


  4. 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 ]

    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.


  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560950


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00560950     History of Changes
Other Study ID Numbers: V110-007
2007_540
First Posted: November 20, 2007    Key Record Dates
Results First Posted: May 25, 2009
Last Update Posted: April 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs