Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-11-30

Brief Summary

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This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

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Detailed Description

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Conditions

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Herpes Zoster Shingles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZOSTAVAX™ (AMP)

ZOSTAVAX™ manufactured with an alternative process

Group Type EXPERIMENTAL

Zoster Vaccine, Live (AMP)

Intervention Type BIOLOGICAL

One approximately 0.65-mL injection subcutaneously on Day 1

ZOSTAVAX™

ZOSTAVAX™ manufactured with the current process

Group Type ACTIVE_COMPARATOR

Zoster Vaccine, Live

Intervention Type BIOLOGICAL

One approximately 0.65-mL injection subcutaneously on Day 1

Interventions

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Zoster Vaccine, Live (AMP)

One approximately 0.65-mL injection subcutaneously on Day 1

Intervention Type BIOLOGICAL

Zoster Vaccine, Live

One approximately 0.65-mL injection subcutaneously on Day 1

Intervention Type BIOLOGICAL

Other Intervention Names

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ZOSTAVAX™ V211

Eligibility Criteria

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Inclusion Criteria

* No fever on day of vaccination
* History of varicella or residence in a VZV-endemic area for ≥30 years
* Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria

* History of hypersensitivity reaction to any vaccine component
* Prior receipt of any varicella or zoster vaccine
* Prior history of herpes zoster
* Have recently had another vaccination
* Pregnant or breastfeeding
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Concomitant antiviral therapy

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes