Phase 4
N=96
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00681031 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Geometric Mean Titre (GMT) of Varicella Antibodies — 215.8; 674.0 gpELISA units/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ZOSTAVAX® (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titre (GMT) of Varicella Antibodies |
215.8; 674.0 | — |
Summary
Primary objective:
To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks post-vaccination.
Secondary objectives:
To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
Eligibility Criteria
Inclusion Criteria
- Participant of either gender aged ≥50 years
- Positive history of varicella or residence for >30 years in a country with endemic VZV infection
- All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination
- Participant having signed the informed consent form prior to any study procedure
Exclusion Criteria
- Febrile within 72 hours prior to vaccination
- Prior history of Herpes Zoster clinically diagnosed by a physician
- Previously received a varicella or zoster vaccine
- Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
- Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
- Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
- Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study
- Taking any non topical antiviral therapy with activity against herpesviruses.
- On immunosuppressive therapy
- Known or suspected immune dysfunction caused by a medical condition, or any other cause
- History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
- Known active tuberculosis
- Significant underlying illness preventing completion of the study
Data sourced from ClinicalTrials.gov (NCT00681031). 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.