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

Pneumococcal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560950
• Other study ID #: V110-007
• Secondary ID: 2007_540
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2007
• Last updated: February 26, 2015
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 59 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• pneumococcal 23v polysaccharide vaccine
Duration of Treatment: Single vaccination on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

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 response — View Citation

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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No