Varicella
Conditions
Brief summary
Seroresponse to VZV gE at Day 43., Anti-VZV gE IgG concentration at Day 43., Seroresponse to MMR antigens at Day 43., Anti-measles, anti-mumps, and anti-rubella IgG concentration at Day 43.
Detailed description
Seroresponse to MMR antigens at Day 43., Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of VNS vaccine or VV administration., Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of MMR vaccine administration., Percentage of participants reporting each solicited systemic event in terms of drowsiness, loss of appetite, and irritability within 15 days (Day 1 to Day 15) post-dose of study interventions administration., Percentage of participants reporting each solicited systemic event in terms of fever within 22 days (Day 1 to Day 22) post-dose of study interventions administration., Percentage of participants reporting each solicited administration site and systemic event in terms of injection site varicella-like rash, varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella-like and not measles/rubella like) within 43 days (Day 1 to Day 43) post dose of study interventions administration as assessed by the investigator, Unsolicited adverse events (AEs) • Percentage of participants reporting unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration., Medically attended AEs (MAAEs) • Percentage of participants reporting MAAEs from Day 1 post-dose of study interventions administration up to study end (Day 181)., Serious adverse events (SAEs) • Percentage of participants reporting SAEs from Day 1 post-dose of study interventions administration up to study end (Day 181)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroresponse to VZV gE at Day 43., Anti-VZV gE IgG concentration at Day 43., Seroresponse to MMR antigens at Day 43., Anti-measles, anti-mumps, and anti-rubella IgG concentration at Day 43. | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroresponse to MMR antigens at Day 43., Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of VNS vaccine or VV administration., Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of MMR vaccine administration., Percentage of participants reporting each solicited systemic event in terms of drowsiness, loss of appetite, and irritability within 15 days (Day 1 to Day 15) post-dose of study interventions administration., Percentage of participants reporting each solicited systemic event in terms of fever within 22 days (Day 1 to Day 22) post-dose of study interventions administration., Percentage of participants reporting each solicited administration site and systemic event in terms of injection site varicella-like rash, varicella-like rash (non- | — |
Countries
Belgium, Bulgaria, Denmark, Estonia, Greece, Lithuania, Poland, Romania