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A Phase 3a, open-label, randomized, controlled study to evaluate the immunogenicity and safety of intramuscular administration of an investigational varicella vaccine and Priorix compared with subcutaneous administration of Varivax and Priorix, when given as a first dose to healthy children 12 to 15 months of age

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518840-18-00
Acronym
223105
Enrollment
310
Registered
2025-08-11
Start date
2025-12-10
Completion date
Unknown
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella

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

DRUGPriorix - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Fertigspritze Masern-Mumps-Röteln-Lebendimpfstoff
DRUGPriorix - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Fertigspritze|Masern-Mumps-Röteln-Lebendimpfstoff

Sponsors

GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026