Immunogenicity and safety of an investigational quadrivalent measles, mumps, rubella, and varicella vaccine in children aged 4-6 years: A phase II, randomized, multi-country trial.
Md Ahsan Habib, Teena Hughes, Li-Min Huang et al.
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In 30 seconds
This phase II, randomized, multi-country trial evaluated the immunogenicity and safety of an investigational quadrivalent measles, mumps, rubella, and varicella vaccine (MMRVNS) in healthy children aged 4-6 years. The study found that MMRVNS generated comparable immune responses and safety profiles to a licensed MMRV vaccine. Of 796 vaccinated participants, the most common adverse events included administration-site pain (29.0%-39.0%) and systemic drowsiness (9.0%-15.9%).
Key findings
- Antigen-specific antibody geometric mean concentrations were comparable between MMRVNS and licensed MMRV vaccine recipients.
- Administration-site pain was reported by 29.0%-39.0% of participants.
- Systemic drowsiness occurred in 9.0%-15.9% of participants.
- At least one serious adverse event occurred in each group, none considered vaccine-related.
Why it matters
The study's findings suggest that the investigational MMRVNS vaccine could provide an alternative option for childhood vaccination against measles, mumps, rubella, and varicella, potentially enhancing vaccine supply and coverage.