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)

Herpes Zoster Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519855
• Other study ID #: V211-062
• Status: Completed
• Phase: Phase 3
• Start date: September 11, 2015
• Est. completion date: January 26, 2016

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: January 26, 2016
• Est. primary completion date: January 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
• Placebo to ZOSTAVAX™
A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
• Influenza Vaccine
A single open-label administration of 0.5 mL intramuscular injection on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Levin MJ, Buchwald UK, Gardner J, Martin J, Stek JE, Brown E, Popmihajlov Z. Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. Vaccine. 2018 Jan 2;36(1):179-185. doi: 10.1016/j.vaccine.2017.08.029. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody	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.	Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
Primary	Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers	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.	Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)
Primary	Geometric Mean Titers of H1N1-specific Influenza Virus Antibody	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.	Baseline and 4 weeks after Influenza vaccination (Week 4)
Primary	Geometric Mean Titers of H3N2-specific Influenza Virus Antibody	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.	Baseline and 4 weeks after Influenza vaccination (Week 4)
Primary	Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody	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.	Baseline and 4 weeks after Influenza vaccination (Week 4)
Primary	Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody	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.	Baseline and 4 weeks after Influenza vaccination (Week 4)