Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

Abstract

This study compared intramuscular and subcutaneous administration of two doses of measles-mumps-rubella-varicella (MMRV) combination vaccine (Priorix-Tetra, GlaxoSmithKline Biologicals) in children. Healthy children (N = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0-3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42-56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

Two mucosal–parenteral schedules to coadminister a multiantigenic formulation against HIV-1 in Balb/c mice

“…However, such discrepancy might be explained by differences in the immunogens, doses of antigens and adjuvants, as well as difference in the schedule of immunization (they tested two doses and we tested four). Although, another difference was the route for parenteral immunization (IM vs SC), we do not believe that it could account for any significant difference because the consensus is that IM and SC immunization of vaccines induce a similar immune response [43][44][45][46][47][48]. It is important to note that two nasal doses is a better option in mucosal-parenteral co-administration schedules to assure efficient priming due to technical issues associated with this inoculation route.…”

Risk of febrile seizure after measles–mumps–rubella–varicella vaccine: A systematic review and meta-analysis

“…Additionally, four clinical trials studied the influence of administration route, composition and vaccination age on the safety of MMRV vaccine [37,[44][45][46]. There was no statistical difference in the incidence of febrile seizure or vaccine related febrile seizure among different administration routes, compositions and vaccination ages of MMRV vaccine.…”

“…Within a smaller risk window of 7-10 days after first vaccine dose, 11 febrile seizure cases and 9 vaccine related febrile seizure cases were reported respectively in 13,129 and 25,433 vaccinated children aged 9-24 months [26][27][28][29][30][33][34][35][37][38][39][40][41][42][43][45][46][47][48][49][50]. In 16 studies informed the prognosis [27][28][29][30][31][32][33][34][35][36][37]39,40,45,48,49], a total of 42 febrile seizures were reported, and these cases all recovered without any sequelae.…”

“…Incidence of febrile seizures and vaccine related febrile seizures was similar or lower within 0-28/42 days or 7-10 days after second MMRV vaccine dose than that after first MMRV vaccine dose in most studies [27][28][29]35,37,40,[44][45][46]48,50]. Ten RCTs [27,30,33,35,36,40,48,50] were included in the meta-analysis to analyze the incidence of febrile seizure and vaccine related febrile seizure within 0-28/42 days or 7-10 days after second MMRV vaccine dose in healthy children aged 9-24 months (Table 2), one or even zero febrile seizure or vaccine related febrile seizure was reported after the second dose in each group in these studies (Table 1).…”

“…Twenty-nine clinical trials [26][27][28][29][30][31][32][33][34][35][37][38][39][40][41][42][43][44][45][46][47][48][49][50] reported the incidence of febrile seizure or vaccine related febrile seizure within 0-28, 0-42 or 0-56 days (0-28/42/56 days) after first MMRV vaccine dose in healthy children aged 9-24 months, twenty-five of them [26][27][28][29][30][33][34][35][37][38][39][40][41][42][43][45][46][47][48][49][50] also reported the incidence within a smaller risk window of 7 to 10 days (7-10 days) after vaccination. Children in 17 clinical trials [27][28][29]…”