Gold R, Scheifele D, Barreto L, Wiltsey S, Bjornson G, Meekison W, Guasparini R, Medd L
Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada.
Pediatr Infect Dis J. 1994 May;13(5):348-55. doi: 10.1097/00006454-199405000-00004.
The safety and immunogenicity of Haemophilus influenzae vaccine (tetanus toxoid conjugate (PRP-T) administered concurrently in separate sites or mixed in the same syringe with diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine were assessed in 439 infants at 2, 4 and 6 months of age. The proportions with local redness, tenderness and swelling in the separate and combined groups were 18% vs. 11% (P < 0.001), 27% vs. 24% and 15% vs. 13%, respectively. Systemic reactions occurred at similar rates in both groups. The combined vaccine induced tetanus and diphtheria antitoxin titers > or = 0.01 IU/ml in 99.5 and 99.1% of infants, pertussis agglutinin titers > or = 64 in 92.4%, anti-polyribosylribitol phosphate titers > or = 0.15 microgram/ml in 93.8% and > or = 1.0 microgram/ml in 75% and polio-neutralizing titers > or = 8 in > 98% of infants. However, antibody concentrations to PRP-T, some pertussis antigens and tetanus toxoid were significantly lower after combined than after separate injections of DPT/diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine and PRP-T. The clinical significance of these differences is not known, but the interactions observed among the components of the pentavalent vaccine may be of concern because they might influence antibody persistence until the fourth dose is administered.
在439名2、4和6月龄婴儿中评估了流感嗜血杆菌疫苗（破伤风类毒素结合物，即PRP-T）分别在不同部位同时接种或与白喉和破伤风类毒素、百日咳疫苗及灭活脊髓灰质炎疫苗混合于同一注射器中接种的安全性和免疫原性。单独接种组和联合接种组出现局部发红、压痛和肿胀的比例分别为18%对11%（P<0.001）、27%对24%以及15%对13%。两组全身反应发生率相似。联合疫苗在99.5%和99.1%的婴儿中诱导破伤风和白喉抗毒素滴度≥0.01 IU/ml，在92.4%的婴儿中诱导百日咳凝集素滴度≥64，在93.8%的婴儿中诱导抗多聚核糖基核糖醇磷酸滴度≥0.15μg/ml，在75%的婴儿中诱导抗多聚核糖基核糖醇磷酸滴度≥1.0μg/ml，在>98%的婴儿中诱导脊髓灰质炎中和滴度≥8。然而，联合接种后PRP-T、某些百日咳抗原和破伤风类毒素的抗体浓度显著低于分别接种白喉和破伤风类毒素、百日咳疫苗及灭活脊髓灰质炎疫苗和PRP-T后的浓度。这些差异的临床意义尚不清楚，但五价疫苗各成分间观察到的相互作用可能令人担忧，因为它们可能会影响抗体持续存在直至接种第四剂。
