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Analysis of safety data in children after receiving two doses of ProQuad® (MMRV)

Stephanie O Klopfer1, Jon E Stek1, Maria Petrecz1

  • 1Merck & Co., Inc, Whitehouse Station, NJ, United States.

Vaccine
|September 16, 2014
PubMed

Insights

The measles, mumps, rubella, and varicella (MMRV) vaccine is safe for children aged 12-23 months. While the first dose shows a slight increase in febrile seizure risk, overall safety remains acceptable.

Area of Science:

  • Pediatrics
  • Immunology
  • Vaccinology

Background:

  • ProQuad(®), a measles, mumps, rubella, and varicella vaccine (MMRV), was administered to over 11,800 children aged 12 months to 6 years in clinical studies.
  • This study specifically evaluates the safety of a two-dose MMRV regimen in children during their second year of life.

Purpose of the Study:

  • To assess the safety profile of a two-dose regimen of the measles, mumps, rubella, and varicella (MMRV) vaccine.
  • To analyze adverse events and specific risks, such as febrile seizures, following each dose of MMRV in young children.

Main Methods:

  • Combined safety data from five clinical studies involving children scheduled for two MMRV doses.
  • Monitored all vaccinated children for safety outcomes after each MMRV dose, with doses administered approximately 3-6 months apart.

Main Results:

  • Of 3112 children receiving the first MMRV dose, 2780 (89.3%) received the second.
  • Adverse experiences were reported by 70.5% after the first dose and 57.7% after the second.
  • Injection-site redness was higher post-dose 2, while pain/tenderness was higher post-dose 1. Rashes were less frequent post-dose 2.
  • Ten febrile seizures occurred (8 post-dose 1, 2 post-dose 2), with incidences of 0.26% post-dose 1 and 0.07% post-dose 2.

Conclusions:

  • The two-dose MMRV vaccination regimen demonstrates an acceptable safety profile in children aged 12 to 23 months.
  • A minor increase in febrile seizure risk is observed after the first MMRV dose compared to component vaccines, but the individual risk remains low.
Abstract

Keywords:
Integrated analysesMMRVNCT00109343NCT00312858NCT00326183NCT00975507NCT00986232ProQuad(®)SafetyTolerability

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