Phase 3 Completed N=498 Randomized Double-blind Prevention

Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

Herpes Zoster · Shingles

Source: ClinicalTrials.gov NCT01505647 ↗

Enrolled (actual)

498

Serious AEs

2.4%

Results posted

Jul 2013

Primary outcomePrimary: Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody — 235.7; 208.2; 532.6; 457.1 Units/mL — p=<0.001

Summary

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody	235.7; 208.2; 532.6; 457.1	<0.001 sig
PRIMARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers	2.3; 2.2	<0.001 sig
SECONDARY Number of Participants With One or More Adverse Experiences (AEs)	205; 99	—
SECONDARY Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination	1; 2	—
SECONDARY Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination	4; 8	—

Eligibility Criteria

Inclusion Criteria

No fever on day of vaccination
History of varicella or residence in a VZV-endemic area for ≥30 years
Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria

History of hypersensitivity reaction to any vaccine component
Prior receipt of any varicella or zoster vaccine
Prior history of herpes zoster
Have recently had another vaccination
Pregnant or breastfeeding
Use of immunosuppressive therapy
Known or suspected immune dysfunction
Concomitant antiviral therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01505647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.