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OpenTrials
Completed

NCT Number: NCT02519855

Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)

The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections 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

  • Has history of varicella or residence in a VZV-endemic area for ≥30 years
  • Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study

Exclusion criteria

  • Has history of hypersensitivity to any vaccine component
  • Has previously received any varicella or zoster vaccine
  • Has received an influenza vaccine for the 2015-16 season
  • Has history of Herpes zoster
  • Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
  • Is pregnant or breastfeeding, or expecting to conceive during the study
  • Has used immunosuppressant therapy
  • Has known or suspected immune dysfunction
  • Has experienced Guillain-Barré syndrome within 6 weeks
  • Has severe thrombocytopenia or any other coagulation disorder

Treatment and study plan

Zostavax™

Biological

A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)

Other names: V211

Placebo to ZOSTAVAX™

Biological

A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)

influenza vaccine

Biological

A single open-label administration of 0.5 mL intramuscular injection on Day 1

Other names: Fluzone, Vaxigrip

Primary outcomes

  1. Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody

    Time frame: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)

    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.

  2. Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers

    Time frame: Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)

    Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.

  3. Geometric Mean Titers of H1N1-specific Influenza Virus Antibody

    Time frame: Baseline and 4 weeks after Influenza vaccination (Week 4)

    Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

  4. Geometric Mean Titers of H3N2-specific Influenza Virus Antibody

    Time frame: Baseline and 4 weeks after Influenza vaccination (Week 4)

    Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

  5. Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody

    Time frame: Baseline and 4 weeks after Influenza vaccination (Week 4)

    Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

  6. Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody

    Time frame: Baseline and 4 weeks after Influenza vaccination (Week 4)

    Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2015
Registry last updated
Oct 30, 2018

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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