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A Phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of a measles, mumps, rubella, varicella vaccine compared with ProQuad, administered in healthy children 4 to 6 years of age

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501564-18-00
Acronym
217715
Enrollment
110
Registered
2023-04-19
Start date
2023-07-31
Completion date
2024-10-10
Last updated
2024-05-23

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

Conditions

Healthy volunteers (prevention of measles, mumps, rubella and varicella infections)

Brief summary

Anti-measles antibody geometric mean concentrations (GMCs) at Day 43., Anti-mumps antibody geometric mean concentrations (GMCs ) at Day 43., Anti-rubella antibody geometric mean concentrations (GMCs) at Day 43., Anti-glycoprotein E (gE) antibody geometric mean concentrations (GMCs) at Day 43.

Detailed description

Percentage of participants with seroresponse to anti-measles antibodies at Day 43., Percentage of participants with seroresponse to anti-mumps antibodies at Day 43., Percentage of participants with seroresponse to anti-rubella antibodies at Day 43., Percentage of participants with seroresponse to varicella anti-gE antibodies at Day 43., Percentage of participants reporting each solicited administration site event during the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1)., Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite during the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1), Percentage of participants reporting each solicited systemic event in terms of fever, measles/rubella-like rash, varicella-like rash and other rash (not measles/rubella-like rash or varicella-like rash) during the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at Day 1)., Percentage of participants reporting unsolicited adverse events (AEs) during the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at Day 1), Percentage of participants reporting serious adverse events (SAEs) throughout the entire study period (From Day 1 to Day 181).

Interventions

DRUGProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles
DRUGmumps
DRUGrubella and varicella vaccine (live)

Sponsors

GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Anti-measles antibody geometric mean concentrations (GMCs) at Day 43., Anti-mumps antibody geometric mean concentrations (GMCs ) at Day 43., Anti-rubella antibody geometric mean concentrations (GMCs) at Day 43., Anti-glycoprotein E (gE) antibody geometric mean concentrations (GMCs) at Day 43.

Secondary

MeasureTime frame
Percentage of participants with seroresponse to anti-measles antibodies at Day 43., Percentage of participants with seroresponse to anti-mumps antibodies at Day 43., Percentage of participants with seroresponse to anti-rubella antibodies at Day 43., Percentage of participants with seroresponse to varicella anti-gE antibodies at Day 43., Percentage of participants reporting each solicited administration site event during the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1)., Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite during the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1), Percentage of participants reporting each solicited systemic event in terms of fever, measles/rubella-like rash, varicella-like rash and other rash (not measles/rubella-like rash or varic

Countries

Latvia, Spain

Outcome results

None listed

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