Olivier C, Belohradsky B H, Stojanov S, Bonnet E, Petersen G, Liese J G
Hôpital L. Mourier, Colombes, France.
Vaccine. 2008 Jun 13;26(25):3142-52. doi: 10.1016/j.vaccine.2007.11.096. Epub 2008 May 6.
To evaluate the immunogenicity, safety and reactogenicity of a seven-valent pneumococcal conjugate vaccine (PCV7) when given concomitantly with a fully liquid DTaP-IPV-HBV-Hib combination vaccine.
Two hundred and sixty-six healthy infants in France (n=136) and Germany (n=130) were randomized to receive DTaP-IPV-HBV-Hib and PCV7 (test group) at the age of 2, 3 and 4 months (primary series) and 12-15 months (booster dose), or to receive DTaP-IPV-HBV-Hib at the same time points but PCV7 at the ages of 5, 6, 7 and 13-16 months (control group). Antibody levels to all vaccine antigens were measured before dose 1, 1 month after dose 3, at the time of booster, and 1 month later. Safety data were collected after each vaccine dose.
Two hundred and fifty-seven infants (test group, 131; control group, 126) completed the primary immunization series and two hundred and forty-five received the booster dose (test group, 125; control group, 120). Depending on the serotype, 92.8-100% of subjects in the test group achieved antibody levels >or=0.15 microg/mL for PCV7 antigens at 5 months of age, and 89.7-99.1% of them antibody levels >or=0.50 microg/mL 1 month after booster. For DTaP-IPV-HBV-Hib, there was no statistically significant difference between the two groups in the proportion of infants that achieved pre-defined seroprotective levels for each antigen at 5 months and 1 month after booster. Frequency of local and systemic reactions was similar in both groups except for fever above 38.0 degrees C, which was more frequent in the test group after dose 1, 2 or 4. Fever >39.0 degrees C was only reported from three children in each group.
The PCV7 vaccine was highly immunogenic, well tolerated, and safe when coadministered with the DTPa-IPV-HBV-Hib vaccine at 2, 3, and 4 months of age and a booster dose at 12-15 months. In this study, PCV7 did not show any relevant influence on the immunogenicity and safety of the concurrently administered DTPa-IPV-HBV-Hib vaccine.
评估七价肺炎球菌结合疫苗（PCV7）与全液体百白破-灭活脊髓灰质炎病毒-乙肝- Hib联合疫苗同时接种时的免疫原性、安全性和反应原性。
法国的136名和德国的130名健康婴儿被随机分组，在2、3和4月龄（基础免疫系列）以及12 - 15月龄（加强剂量）时接受百白破-灭活脊髓灰质炎病毒-乙肝- Hib和PCV7（试验组），或者在相同时间点接受百白破-灭活脊髓灰质炎病毒-乙肝- Hib，但在5、6、7和13 - 16月龄时接受PCV7（对照组）。在第1剂之前、第3剂后1个月、加强免疫时以及1个月后测量所有疫苗抗原的抗体水平。每次接种疫苗后收集安全性数据。
257名婴儿（试验组131名；对照组126名）完成了基础免疫系列，245名婴儿接受了加强剂量（试验组125名；对照组120名）。根据血清型，试验组中92.8 - 100%的受试者在5月龄时PCV7抗原的抗体水平≥0.15μg/mL，其中89.7 - 99.1%的受试者在加强免疫后1个月抗体水平≥0.50μg/mL。对于百白破-灭活脊髓灰质炎病毒-乙肝- Hib，两组在5月龄和加强免疫后1个月达到每种抗原预定义血清保护水平的婴儿比例上无统计学显著差异。除体温高于38.0℃外，两组局部和全身反应的频率相似，体温高于38.0℃在试验组第1、2或4剂接种后更常见。每组仅3名儿童报告体温高于39.0℃。
PCV7疫苗在2、3和4月龄与百白破-灭活脊髓灰质炎病毒-乙肝- Hib疫苗同时接种以及在12 - 15月龄进行加强免疫时具有高度免疫原性、耐受性良好且安全。在本研究中，PCV7对同时接种的百白破-灭活脊髓灰质炎病毒-乙肝- Hib疫苗的免疫原性和安全性未显示任何相关影响。
