NCT01505647

Trial name or title	'A phase III double‐blinded, randomised, multicenter, controlled study to evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ made with an alternative manufacturing process (AMP)'
Methods	Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, investigator) Primary purpose: prevention
Participants	498 healthy volunteers, 50 years and older, both genders
Interventions	1. Experimental: Zostavax™ (AMP) Zostavax™ manufactured with an alternative process 2. Active comparator: Zostavax™ manufactured with the current process
Outcomes	Geometric mean titre (GMT) of varicella zoster virus (VZV) antibody, geometric mean fold rise (gmfr) in VZV antibody titres, number of participants with 1 or more adverse experiences (AEs), number of participants with 1 or more serious adverse experience (SAE) day 1 to 42 post‐vaccination, number of participants with 1 or more serious adverse experience day 1 to 182 post‐vaccination
Starting date	April 2012
Contact information	Please refer to this study by its ClinicalTrials.gov identifier: NCT01505647
Notes	This study has been completed. No publications provided