Phase 3
Completed N=354
Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)
Source: ClinicalTrials.gov NCT01391546 ↗Enrolled (actual)
354
Serious AEs
0.9%
Results posted
Nov 2017
Primary outcomePrimary: Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination — 395.3; 391.7 gpELISA units/mL — p=<0.001
◆ Published Evidence
Established
41citations · ~4 / year
Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: a randomised non-inferiority clinical trial.
Summary
PRIMARY OBJECTIVES
Two co-primary objectives are:
* To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
* To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination
SECONDARY OBJECTIVES
Immunogenicity objectives
* To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
* To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route
Safety objective
- To describe the safety profile of ZOSTAVAX administered by IM or SC route
Linked Publications
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Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: a randomised non-inferiority clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination |
395.3; 391.7 | <0.001 sig |
| PRIMARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route |
2.7 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route |
2.5 | — |
| SECONDARY Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies |
209.8; 195.7 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies |
3.3; 3.4 | — |
| SECONDARY Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction |
34.1; 64.4 | — |
| SECONDARY Percentage of Participants Who Report at Least 1 Systemic Adverse Event |
23.3; 22.6 | — |
| SECONDARY Percentage of Participants Who Report at Least 1 Serious Adverse Event |
0.6; 1.1 | — |
Eligibility Criteria
Inclusion Criteria
- Adults aged >=50 years
- Varicella history-positive or residence for >30 years in a country with endemic VZV infection
Exclusion Criteria
- Febrile illness
- History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
- Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
- Prior receipt of varicella or zoster vaccine
- Active untreated tuberculosis
- Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
- Receipt of medication / vaccine that may interfere with study assessments
- Known or suspected immune dysfunction
- User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
- Any condition that might interfere with the interpretation of the study,
Data sourced from ClinicalTrials.gov (NCT01391546) and the linked publication. 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.