Measles, mumps, rubella, varicella
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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). | — |