At a glance
ClinicalIndex Comparison Record- ✓Healthy child aged 12 to 18 months
- ✓No prior measles, mumps, rubella, or varicella (clinical history)
- ✓Parental consent and ability to comply with protocol and diary card
- ✕Prior receipt of measles, mumps, rubella, and/or varicella vaccine (any formulation)
- ✕Recent exposure (≤30 days) to measles, mumps, rubella, varicella, or zoster
- ✕Febrile illness within 3 days
- ✕Severe chronic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ProQuad® When Administered by Intramuscular (IM) Route or Subcutaneous (SC) Route to Healthy Children Aged 12 to 18 Months
In Brief
A Phase 3 clinical trial evaluating ProQuad® for Measles and 3 related conditions. Completed, enrolled 405 participants.
Detailed Summary
Primary objective: To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad® Secondary objectives: * To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route, * To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route, * To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.
Study Details
Timeline
Interventions
Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.