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

Merck Sharp & Dohme LLC143 enrolled

Overview

The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

143

Conditions

Pneumococcal Infection

Interventions

pneumococcal 23v polysaccharide vaccineBIOLOGICAL

Duration of Treatment: Single vaccination on Day 1

Eligibility

Sex: ALLMin age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 1 & Day 30

Data from ClinicalTrials.gov

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