ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster; Pneumococcal Infection

Treatments: Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23; Biological: Comparator: placebo (concomitant-vaccine matched); Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00535730

2007_592

V211-012

Details and patient eligibility

About

The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.

Enrollment: 473 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 60 years of age or older
• Stable underlying conditions
• Postmenopausal if female
• Afebrile

Exclusion criteria

• Previously vaccinated with either vaccine
• Immune deficiency
• History of allergy to components in either vaccine
• Concomitant antiviral therapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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473 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Biological: Comparator: placebo (concomitant-vaccine matched)

Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™

2

Experimental group

Description:

vaccine

Treatment:

Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™

Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23