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A Phase 3a, observer blind, randomized, controlled study to evaluate the immunogenicity and safety of intramuscular administration of an investigational combined measles, mumps, rubella, and varicella vaccine compared with intramuscular administration of ProQuad when administered as a second dose to healthy children aged 15 months to 6 years of age

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523274-17-00
Enrollment
160
Registered
2026-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-18

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

Conditions

Measles, mumps, rubella, varicella

Brief summary

Seroresponse of Immunoglobulin G (IgG) concentrations against measles at day 43., Seroresponse of IgG concentrations against mumps at day 43., Seroresponse of IgG concentrations against rubella at day 43., Seroresponse of IgG concentrations against Varicella zoster virus (VZV) at day 43., IgG concentrations against measles at day 43., IgG concentrations against mumps at day 43., IgG concentrations against rubella at day 43., IgG concentrations against VZV at day 43.

Detailed description

Number of participants with any solicited administration site events from Day 1 to Day 4 for injection site redness, pain/tenderness and swelling; and from Day 1 to Day 43 for injection site varicella-like rash., Number of participants with any solicited systemic events from Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; and Day 1 to Day 43 for varicella-like rash, measles/rubella-like rash and other rash., Number of participants with any unsolicited adverse events (AEs) from Day 1 up to Day 43 (during the 43 days following study intervention administration)., Number of participants with any medically attended adverse events (MAAEs) from Day 1 up to Day 181 (during the 181 days following study intervention administration)., Number of participants with any serious AEs (SAEs), fatal SAEs, related SAEs from Day 1 up to study end (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
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Seroresponse of Immunoglobulin G (IgG) concentrations against measles at day 43., Seroresponse of IgG concentrations against mumps at day 43., Seroresponse of IgG concentrations against rubella at day 43., Seroresponse of IgG concentrations against Varicella zoster virus (VZV) at day 43., IgG concentrations against measles at day 43., IgG concentrations against mumps at day 43., IgG concentrations against rubella at day 43., IgG concentrations against VZV at day 43.

Secondary

MeasureTime frame
Number of participants with any solicited administration site events from Day 1 to Day 4 for injection site redness, pain/tenderness and swelling; and from Day 1 to Day 43 for injection site varicella-like rash., Number of participants with any solicited systemic events from Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; and Day 1 to Day 43 for varicella-like rash, measles/rubella-like rash and other rash., Number of participants with any unsolicited adverse events (AEs) from Day 1 up to Day 43 (during the 43 days following study intervention administration)., Number of participants with any medically attended adverse events (MAAEs) from Day 1 up to Day 181 (during the 181 days following study intervention administration)., Number of participants with any serious AEs (SAEs), fatal SAEs, related SAEs from Day 1 up to study end (Day 181).

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 19, 2026