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

Phase 3

Completed

• Conditions: Pneumococcal Infection
• Interventions: Biological: pneumococcal 23v polysaccharide vaccine

• Registration Number: NCT00560950
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-03-30
• Results First Submitted QC: 2009-03-30
• Results First Posted: 2009-05-25
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2nd Revaccination Group	pneumococcal 23v polysaccharide vaccine	-
1st Revaccination Group	pneumococcal 23v polysaccharide vaccine	-

Primary Outcome Measures

Name	Time	Method
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F	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.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F	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.