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Completed

NCT Number: NCT01505647

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

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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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Shingles Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine, Live (AMP)

Biological

One approximately 0.65-mL injection subcutaneously on Day 1

Zoster Vaccine, Live

Biological

One approximately 0.65-mL injection subcutaneously on Day 1

Other names: ZOSTAVAX™, V211

Primary outcomes

  1. Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody

    Time frame: Day 1 and Week 6 postvaccination

    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)

  2. Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers

    Time frame: Day 1 (Baseline) to Week 6 postvaccination

    VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).

Secondary outcomes

  1. Number of Participants With One or More Adverse Experiences (AEs)

    Time frame: Day 1 to Day 42 postvaccination

    An AE is defined as any unfavorable and unintended change in the

    structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

  2. Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination

    Time frame: Day 1 to Day 42 postvaccination

    An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement

  3. Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination

    Time frame: Day 1 to Day 182 postvaccination

    An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2012
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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