West D J, Rabalais G P, Watson B, Keyserling H L, Matthews H, Hesley T M
BioDrugs. 2001;15(6):413-8. doi: 10.2165/00063030-200115060-00007.
To confirm that children given a bivalent Haemophilus influenzae type b-hepatitis B vaccine (bivalent Hib-HB vaccine; COMVAX) concurrently with priming doses of diphtheria-tetanus-pertussis vaccine (DTP), a booster dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP), inactivated or oral polio vaccine (IPV or OPV) and measles-mumps-rubella vaccine (M-M-R(II)) have satisfactory antibody responses to all antigens.
126 healthy 2-month-old infants were scheduled to receive bivalent Hib-HB vaccine concurrently with DTP (2 and 4 months of age), OPV or IPV (random allocation to OPV or IPV at 2 months of age; OPV at 4 and 14 to 15 months of age), DTaP and M-M-R(II) (14 to 15 months of age). A response was judged "adequate" if the lower bound of the 95% confidence interval on the proportion of vaccinees having a critical antibody level was <10 percentage points below prediction.
Antibodies to hepatitis B virus surface antigen, H. influenzae polysaccharide, diphtheria toxin, tetanus toxin, pertussis agglutinogens, pertussis toxin (as measured by enzyme immunoassay but not by Chinese hamster ovary cell assay), pertussis filamentous haemagglutinin after a booster dose of DTaP, poliovirus type 2, measles virus, and mumps virus all equalled or exceeded expected levels. Antibodies to rubella virus and pertussis filamentous haemagglutinin (after priming doses of DTP) fell slightly, and in the case of rubella significantly, below predicted levels. Antibodies to poliovirus types 1 and 3 were also below expectation after 2 doses of polio vaccine but were adequate following a third dose of vaccine.
Concurrent administration of bivalent Hib-HB vaccine with priming doses of DTP, a booster dose of DTaP, OPV, IPV, or M-M-R(II) was well tolerated and, with the possible exception of rubella, did not substantially impair the antibody response to any antigen.
确认给予2月龄儿童同时接种b型流感嗜血杆菌-乙肝二价疫苗（bivalent Hib-HB疫苗；COMVAX）与白喉-破伤风-百日咳疫苗（DTP）的基础免疫剂量、白喉-破伤风-无细胞百日咳疫苗（DTaP）的加强免疫剂量、灭活或口服脊髓灰质炎疫苗（IPV或OPV）以及麻疹-腮腺炎-风疹疫苗（M-M-R(II)）后，儿童对所有抗原均有满意的抗体反应。
126名健康的2月龄婴儿计划同时接种bivalent Hib-HB疫苗与DTP（2月龄和4月龄）、OPV或IPV（2月龄时随机分配接种OPV或IPV；4月龄以及14至15月龄接种OPV）、DTaP和M-M-R(II)（14至15月龄）。如果具有临界抗体水平的疫苗接种者比例的95%置信区间下限比预测值低不到10个百分点，则判断为“充分”反应。
乙肝病毒表面抗原、b型流感嗜血杆菌多糖、白喉毒素、破伤风毒素、百日咳凝集原、百日咳毒素（通过酶免疫测定法检测，但中国仓鼠卵巢细胞测定法未检测）、DTaP加强免疫剂量后的百日咳丝状血凝素、2型脊髓灰质炎病毒、麻疹病毒和腮腺炎病毒的抗体均等于或超过预期水平。风疹病毒和百日咳丝状血凝素（DTP基础免疫剂量后）的抗体略有下降，风疹抗体显著低于预测水平。2剂脊髓灰质炎疫苗后，1型和3型脊髓灰质炎病毒的抗体也低于预期，但第3剂疫苗后抗体充足。
同时接种bivalent Hib-HB疫苗与DTP基础免疫剂量、DTaP加强免疫剂量、OPV、IPV或M-M-R(II)耐受性良好，除风疹外，对任何抗原的抗体反应均未受到实质性损害。
