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Lot-to-lot Consistency of Recombinant Herpes Zoster Vaccine in Subjects Aged 40 Years and Older
NCT06654700Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2024
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- MAXVAX Biotechnology
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- herpes zoster (HZ)
01
Overview
Phase 3, randomised, double-blind trial of Zoster vaccine recombinant in herpes zoster (HZ) (3 arms), sponsored by MAXVAX Biotechnology. Primary endpoint: Geometric Mean Concentration of anti-gE antibodies at Month 3. Started Dec 2024; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Commercial-scale batch 1
Subjects receive Recombinant Zoster Vaccine (CHO cell) Batch 1 on a 0, 2-month schedule
Commercial-scale batch 2
Subjects receive Recombinant Zoster Vaccine (CHO cell) Batch 2 on a 0, 2-month schedule
Commercial-scale batch 3
Subjects receive Recombinant Zoster Vaccine (CHO cell) Batch 3 on a 0, 2-month schedule
03
Who it enrols
Healthy adults aged 40 years and older, with no history of herpes zoster or previous vaccination against varicella/herpes zoster, and no severe chronic diseases, immunodeficiency, or recent receipt of immunosuppressive therapy or immunoglobulins.
04
Endpoints
Primary
Geometric Mean Concentration of anti-gE antibodies
Secondary
Seroconversion rate of anti-gE antibodies
Incidence of solicited local adverse events
Incidence of solicited general adverse events
Incidence of unsolicited adverse events
Incidence of serious adverse events
Incidence of potential immune-mediated diseases
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