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

作者：Klopfer Stephanie O^*; Stek Jon E; Petrecz Maria; Reisinger Keith S; Black Steven B; Goveia Michelle G; Nicholson Ouzama; Gardner Julie L; Grosso Anthony D; Brown Michelle L; Kuter Barbara J; Schoedel Florian P

来源：Vaccine, 2014, 32(52): 7154-7160.

DOI：10.1016/j.vaccine.2014.08.067

• Safety
• MMRV
• ProQuad (R)
• Integrated analyses
• Tolerability
• NCT00975507
• NCT00986232
• NCT00109343
• NCT00326183
• NCT00312858

Background: In randomized clinical studies, over 11,800 children, 12 months to 6 years of age, were administered ProQuad (R) a combination measles, mumps, rubella, and varicella vaccine (MMRV). This paper describes the safety following a 2-dose regimen of MMRV administered to children in the second year of life.
Methods: Safety data from five clinical studies were combined for all children who were scheduled to receive two doses of MMRV similar to 3-6 months apart. All vaccinated children were followed for safety following each dose of MMRV.
Results: Of 3112 children who received a first dose of MMRV, 2780 (89.3%) received a second dose of MMRV. Overall, 70.5% and 57.7% of children reported >= 1 adverse experiences following first and second doses of MMRV, respectively. Injection-site redness was statistically significantly higher postdose 2 than postdose 1, while injection-site pain/tenderness was statistically significantly higher postdose 1 compared to postdose 2. Rashes were statistically significantly lower postdose 2 compared to postdose 1. Ten febrile seizures (8 postdose 1, 2 postdose 2) were reported following MMRV vaccination. The incidence of febrile seizures postdose 1 of MMRV was 0.26% (8/3019) compared to 0.07% (2/2695) postdose 2 of MMRV.
Conclusions: Administration of two doses of MMRV has an acceptable safety profile in children 12 to 23 months of age. There is a small increase in the risk of febrile seizures following the first dose of MMRV as compared to the component vaccines, but the risk for any individual child is relatively low.

• 出版日期2014-12-12