ProQuad® Intramuscular vs Subcutaneous

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.

Timeline

Start

2006-10-06

Primary completion

2007-05-11

Completion

2007-05-11

Outcome

Met primary endpoint

paper lower bounds of the two-sided 95% CIs for the difference in response rates for all antigens greater than -10% PMID 30481110 ↗

paper The 2-dose regimen of MMRV administered IM was shown to be as immunogenic as the 2-dose regimen administered SC PMID 30481110 ↗

Publications

• Haas H, Richard P, Eymin C, Fiquet A, Kuter B, Soubeyrand B. Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles, mumps, rubella, and varicella vaccine to children 12 to 18 months of age. Hum Vaccin Immunother. 2019;15(4):778-785. doi: 10.1080/21645515.2018.1549452. Epub 2019 Jan 8.

Drugs

Indications