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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infection

Treatments: Biological: pneumococcal 23v polysaccharide vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560950

V110-007

2007_540

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 59+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

1st Revaccination Group

Experimental group

Treatment:

Biological: pneumococcal 23v polysaccharide vaccine

2nd Revaccination Group

Experimental group

Treatment:

Biological: pneumococcal 23v polysaccharide vaccine