A Phase 3a, observer-blind, randomized, controlled study to evaluate the safety of an investigational varicella vaccine compared with Varivax, administered as a first dose to healthy children 12 to 15 months of age.

Conditions

Varicella

Brief summary

Occurrence of solicited: •administration site events within 4 days (Day 1 to Day 4) post dose of VNS vaccine or VV administration. •systemic events within 15 days (Day 1 to Day 15) post-dose of study interventions administration. •systemic event (fever) within 22 days (Day 1 to Day 22) post-dose of study interventions administration. •administration site and systemic events (rash) within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Occurrence of any unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Occurrence of any medically attended AEs post-dose of study interventions administration up to study end (Day 181)., Occurrence of SAEs post-dose of study interventions administration up to study end.

Related papers

No related papers found yet.

Interventions

DRUGVARIVAX® Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension in einer Fertigspritze Varizellen-Lebendimpfstoff

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Occurrence of solicited: •administration site events within 4 days (Day 1 to Day 4) post dose of VNS vaccine or VV administration. •systemic events within 15 days (Day 1 to Day 15) post-dose of study interventions administration. •systemic event (fever) within 22 days (Day 1 to Day 22) post-dose of study interventions administration. •administration site and systemic events (rash) within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Occurrence of any unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Occurrence of any medically attended AEs post-dose of study interventions administration up to study end (Day 181)., Occurrence of SAEs post-dose of study interventions administration up to study end.	—

Measure

Time frame

Occurrence of solicited: •administration site events within 4 days (Day 1 to Day 4) post dose of VNS vaccine or VV administration. •systemic events within 15 days (Day 1 to Day 15) post-dose of study interventions administration. •systemic event (fever) within 22 days (Day 1 to Day 22) post-dose of study interventions administration. •administration site and systemic events (rash) within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Occurrence of any unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Occurrence of any medically attended AEs post-dose of study interventions administration up to study end (Day 181)., Occurrence of SAEs post-dose of study interventions administration up to study end.

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Countries

Bulgaria, Denmark, Estonia, Lithuania, Poland

Outcome results

None listed