Gothefors L, Bergström E, Backman M
Department of Clinical Sciences Pediatrics Umeå University, Sweden.
Scand J Infect Dis. 2001;33(7):545-9. doi: 10.1080/00365540110026593.
An open randomized trial involving 301 subjects was conducted in order to compare the reactogenicity and immunogenicity of a new measles, mumps and rubella (MMR) vaccine, SB MMR, with those of a commercial MMR vaccine, Merck MMR, when given as a second dose to children at 11-12 y of age. All subjects had previously received Merck MMR in the first year of life. In initially seronegative subjects, all subjects receiving the Merck MMR vaccine had seroconverted with respect to measles (10/10 subjects), mumps (38/38) and rubella (4/4). Of the subjects receiving SB MMR, 6/7 seroconverted with respect to measles, 29/31 with respect to mumps and 3/3 with respect to rubella. No difference was seen in seroconversion rates or geometric mean values (GMVs) between groups. In initially seropositive subjects, a higher anti-mumps immune response rate was observed in the SB MMR group (59.3%) compared with the Merck MMR group (24.1%). Higher post-vaccination anti-mumps and anti-rubella GMVs were observed in the group receiving SB MMR (p < 0.007), whereas higher anti-measles GMVs were observed in the Merck MMR group (p = 0.0013). There was a lower (p = 0.013) incidence of pain at the injection site in subjects receiving SB MMR (20.1%) compared with Merck MMR (33.3%). Incidences of systemic reactions were similar between groups.
为了比较新型麻疹、腮腺炎和风疹（MMR）疫苗SB MMR与市售MMR疫苗默克MMR在11至12岁儿童作为第二剂接种时的反应原性和免疫原性，开展了一项涉及301名受试者的开放性随机试验。所有受试者在出生后的第一年都接种过默克MMR。在初始血清学阴性的受试者中，所有接种默克MMR疫苗的受试者在麻疹（10/10名受试者）、腮腺炎（38/38）和风疹（4/4）方面均发生了血清转化。在接种SB MMR的受试者中，6/7在麻疹方面发生了血清转化，29/31在腮腺炎方面发生了血清转化，3/3在风疹方面发生了血清转化。两组之间的血清转化率或几何均值（GMV）没有差异。在初始血清学阳性的受试者中，与默克MMR组（24.1%）相比，SB MMR组观察到更高的抗腮腺炎免疫反应率（59.3%）。在接种SB MMR的组中观察到更高的接种后抗腮腺炎和抗风疹GMV（p<0.007），而在默克MMR组中观察到更高的抗麻疹GMV（p = 0.0013）。与默克MMR（33.3%）相比，接种SB MMR的受试者注射部位疼痛的发生率较低（p = 0.013）（20.1%）。两组全身反应的发生率相似。
