Phase 3
N=250
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
Herpes Zoster · Shingles
Bottom Line
View on ClinicalTrials.gov: NCT01527370 ↗Enrolled (actual)
250
Serious AEs
0.8%
Results posted
Dec 2013
Primary outcome: Primary: The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination — 149.8; 410.8 gpELISA units/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoster Vaccine Live (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination |
149.8; 410.8 | — |
| PRIMARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination |
2.8 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
2 | — |
Summary
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
Eligibility Criteria
Inclusion Criteria
- No fever on day of vaccination
- Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
- Underlying chronic illnesses must be stable
Exclusion Criteria
- History of hypersensitivity reaction to any vaccine component
- Prior receipt of a varicella or zoster vaccine
- Prior history of herpes zoster
- Have recently had another vaccination
- Have recently received blood products other than autologous blood transfusion
- Pregnant or breast feeding
- Use of immunosuppressive therapy
- Known or suspected immune dysfunction
- Use of nontopical antiviral therapy with activity against herpesvirus
Data sourced from ClinicalTrials.gov (NCT01527370). 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.