Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and Older

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Abstract
OBJECTIVES: To evaluate the safety and immunogenicity of ZOSTAVAX administered concomitantly with inactivated influenza vaccine or sequentially in adults aged 50 and older.DESIGN: Randomized, blinded, placebo‐controlled study.SETTING: Thirteen U.S. and seven European study sites.PARTICIPANTS: Three hundred eighty‐two concomitantly, 380 sequentially vaccinated subjects.INTERVENTION: The concomitant vaccination group received influenza vaccine and ZOSTAVAX at separate injection sites on Day 1 and placebo at Week 4. The nonconcomitant vaccination group received influenza vaccine and placebo at separate injection sites on Day 1 and ZOSTAVAX at Week 4.MEASUREMENTS: Primary safety endpoints: vaccine‐related serious adverse experiences (AEs) within 28 days postvaccination (PV); and diary card–prompted local and systemic AEs. Primary immunogenicity endpoints: geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline of varicella‐zoster virus (VZV) antibody (Ab) at 4 weeks PV according to glycoprotein enzyme‐linked immunosorbent assay (gpELISA) and GMT of influenza Ab for the three vaccine strains (2005–2006 influenza season) at 4 weeks PV according to hemagglutination inhibition assay. Secondary immunogenicity endpoint: influenza seroconversion rates (SCRs).RESULTS: No serious AEs related to ZOSTAVAX were observed during the study. VZV Ab GMTs 4 weeks PV for the concomitant and sequential groups were 554 and 597 gpELISA U/mL, respectively. The estimated VZV Ab GMT ratio was 0.9 (95% confidence interval (CI)=0.8–1.0), indicating noninferior (P<.001 for the null hypothesis of GMT ratio CONCLUSION: ZOSTAVAX and influenza vaccine given concomitantly are generally well tolerated in adults aged 50 and older. Ab responses were similar whether ZOSTAVAX and influenza vaccine were given concomitantly or sequentially.