Immunogenicity and safety of an investigational varicella zoster vaccine in toddlers aged 12-15 months: results of a phase II, controlled, randomized trial - PubMed
3 hours ago
- #pediatric immunology
- #clinical trial
- #varicella vaccine
- Study assessed immunogenicity and safety of investigational varicella vaccine (VNS) in toddlers aged 12-15 months.
- Phase II, observer-blind, randomized, multicenter, controlled study with 800 participants from four countries.
- Participants received single dose of VNS (low, medium, high potency) or control vaccine, co-administered with other vaccines.
- Immunogenicity assessed 43 days post-vaccination; safety monitored up to 181 days.
- Anti-varicella zoster virus antibody levels were comparable across all study groups.
- Seroresponse rates ranged from 93.6% (VNS-Low) to 98.7% (VNS-High), with control at 98.1%.
- Adverse events and serious adverse events were similar across all groups.
- VNS vaccine showed acceptable safety profile and immunogenicity across all potencies.