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

NCT00560950 | Completed Phase 3 Results

• 2 other identifiers: V110-0072007_540
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (8)

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14

  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.

  Day 1 & Day 30

• Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F

  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.

  Day 1 & Day 30

Study Arms (2)

1st Revaccination Group

EXPERIMENTAL

Biological: pneumococcal 23v polysaccharide vaccine

2nd Revaccination Group

EXPERIMENTAL

Biological: pneumococcal 23v polysaccharide vaccine

Interventions

pneumococcal 23v polysaccharide vaccine BIOLOGICAL

Duration of Treatment: Single vaccination on Day 1

Also known as: V110, PNEUMOVAX

1st Revaccination Group; 2nd Revaccination Group

Eligibility Criteria

• Age: 59 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Musher DM, Manoff SB, McFetridge RD, Liss CL, Marchese RD, Raab J, Rueda AM, Walker ML, Hoover PA. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Hum Vaccin. 2011 Sep;7(9):919-28. doi: 10.4161/hv.7.9.15996. Epub 2011 Sep 1.

  PMID: 21860256 RESULT

• Manoff SB, Liss C, Caulfield MJ, Marchese RD, Silber J, Boslego J, Romero-Steiner S, Rajam G, Glass NE, Whitney CG, Carlone GM. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged 65 > or = years. J Infect Dis. 2010 Feb 15;201(4):525-33. doi: 10.1086/651131.

  PMID: 20088694 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

2,4,5,4'-tetrachlorodiphenylsulfoxide; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Open-label non-randomized group of subjects enrolled in this extension. Subjects recruited from original study which completed five years previously.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 11, 2017
• Results First Posted: May 25, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share