Analysis of safety data in children after receiving two doses of ProQuad registered (MMRV)
Background In randomized clinical studies, over 11,800 children, 12 months to 6 years of age, were administered ProQuad registered , 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...
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Veröffentlicht in: | Vaccine 2014-12, Vol.32 (52), p.7154-7160 |
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Hauptverfasser: | , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | Background In randomized clinical studies, over 11,800 children, 12 months to 6 years of age, were administered ProQuad registered , 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 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 greater than or equal to 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. |
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ISSN: | 0264-410X |
DOI: | 10.1016/j.vaccine.2014.08.067 |