Tichmann-Schumann Irmingard, Soemantri Peter, Behre Ulrich, Disselhoff Johann, Mahler Hans, Maechler Gudrun, Sänger Roland, Jacquet Jeanne-Marie, Schuerman Lode
Medical Practice, Munich, Germany.
Pediatr Infect Dis J. 2005 Jan;24(1):70-7. doi: 10.1097/01.inf.0000148923.46453.48.
BACKGROUND: The 7-valent pneumococcal (7vPn) conjugate vaccine is licensed for primary and booster vaccination according to the same immunization schedules as routinely recommended diphtheria-tetanus-pertussis-based childhood vaccines and can be coadministered during the same vaccination visit. METHODS: An open, randomized study evaluated the immunogenicity and safety of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine and a 7vPn conjugate vaccine when coadministered at 2, 3 and 4 months and 12-23 months of age, compared with the administration of the hexavalent DTPa-HBV-IPV/Hib vaccine given alone. Serum antibody titers were measured before and 1 month after the primary course and before and 1 month after the booster dose. Solicited local and general adverse events were recorded for 4 days and unsolicited adverse events were recorded for 30 days after each vaccine dose. RESULTS: A total of 345 subjects were enrolled for primary vaccination with the hexavalent vaccine (170 without and 175 with the 7vPn vaccine coadministered) and 266 returned for booster vaccination (122 without and 144 with coadministration of the 7vPn vaccine). After primary vaccination, antibody responses against the common antigens were similar in both groups, with seroprotection rates of 93.6-100% and with similar antibody decay before booster vaccination. The fourth dose induced a vigorous booster response, with seroprotection/vaccine response rates of 96.8-100%. Response to the 7vPn primary and booster vaccination was within previously reported ranges. Differences in reactogenicity resulted from higher incidences of symptoms after concomitant vaccination. Rectal temperature >39.5 degrees C was observed after 1.2% of the coadministered vaccine doses during primary vaccination and after 2.8% of the booster vaccine doses. CONCLUSION: Coadministration of the DTPa-HBV-IPV/Hib and 7vPn vaccines at separate injection sites during the same vaccination visit was effective and safe.
背景：7价肺炎球菌（7vPn）结合疫苗已获许可，可按照与常规推荐的基于白喉-破伤风-百日咳的儿童疫苗相同的免疫程序进行初次和加强免疫接种，并且可以在同一次疫苗接种就诊时同时接种。 方法：一项开放性随机研究评估了六价白喉-破伤风-无细胞百日咳-乙型肝炎-灭活脊髓灰质炎病毒-b型流感嗜血杆菌（DTPa-HBV-IPV/Hib）疫苗和7vPn结合疫苗在2、3和4月龄以及12至23月龄同时接种时的免疫原性和安全性，并与单独接种六价DTPa-HBV-IPV/Hib疫苗进行比较。在初次免疫疗程前和后1个月以及加强剂量前和后1个月测量血清抗体滴度。每次疫苗接种后记录4天的主动报告的局部和全身不良事件，并记录30天的被动报告的不良事件。 结果：共有345名受试者登记接受六价疫苗的初次接种（170名未同时接种7vPn疫苗，175名同时接种7vPn疫苗），266名返回接受加强接种（122名未同时接种7vPn疫苗，144名同时接种7vPn疫苗）。初次接种后，两组针对常见抗原的抗体反应相似，血清保护率为93.6%至100%，在加强接种前抗体衰减情况相似。第四剂疫苗引发了强烈的加强反应，血清保护/疫苗反应率为96.8%至100%。对7vPn初次和加强免疫接种的反应在先前报告的范围内。同时接种疫苗后症状发生率较高导致了反应原性的差异。在初次接种期间，1.2%的同时接种疫苗剂量后观察到直肠温度>39.5摄氏度，在加强接种疫苗剂量后，2.8%的情况下观察到该情况。 结论：在同一次疫苗接种就诊时在不同注射部位同时接种DTPa-HBV-IPV/Hib和7vPn疫苗是有效且安全的。
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