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)

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.

Timeline

Start

2015-09-11

Primary completion

2016-01-26

Completion

2016-01-26

Outcome

Met primary endpoint

paper The adjusted VZV antibody GMT ratio (CG/SG) was 0.87 (95%CI: 0.80, 0.95), meeting the prespecified noninferiority criterion. PMID 28830693 ↗

paper The VZV antibody GMFR in the CG was 1.9 (95%CI: 1.76, 2.05), meeting the acceptability criterion. PMID 28830693 ↗

paper The concomitant administration of ZV and IIV4 to adults≥50years of age induced VZV-specific and influenza-specific antibody responses that were comparable to those following administration of either vaccine alone PMID 28830693 ↗

Publications

• Results 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. Epub 2017 Aug 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Influenza vaccine	Vaccine	0.5 ml	Intramuscular
Subject	Zostavax	Vaccine	0.65 ml	Subcutaneous

Indications