TY - JOUR
T1 - A fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine
T2 - immunogenicity and safety of primary vaccination in Taiwanese infants
AU - Lin, Tzou Yien
AU - Wang, Ying Hsiang
AU - Chang, Luan Yin
AU - Huang, Yhu Chering
AU - Kao, Hsiu Tsun
AU - Lin, Pen Yi
AU - Lu, Hsiao Kuo
AU - Chavand, Pascale
AU - Ortiz, Esteban
PY - 2007/3
Y1 - 2007/3
N2 - Objective: To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants. Methods: Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3). Antibody concentrations were measured before the first and after the third dose. Reactogenicity was evaluated from parental reports. All subjects received hepatitis B vaccine at 0, 1, and 6 months of age following the national vaccination schedule of Taiwan. Results: The immunogenicity after the third dose was high for each vaccine antigen in both groups, and the vaccines had low reactogenicity. Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines, notably the anti-PRP (polyribose ribitol phosphate capsular polysaccharide) response, with 97-99% of infants having concentrations ≥1.0 μg/mL. Approximately 95% of all infants developed seroprotective levels of anti-hepatitis B surface antigen (HBs) antibodies (≥10 mIU/mL). Conclusions: Both combination vaccines had similar high immunogenicity for each antigen, and both were well tolerated. Thus, inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity. The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection.
AB - Objective: To assess the immunogenicity of a fully liquid diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine compared to DTaP-IPV and lyophilized Hib conjugate vaccines given simultaneously at separate sites as a three-dose primary vaccination in Taiwanese infants. Methods: Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3). Antibody concentrations were measured before the first and after the third dose. Reactogenicity was evaluated from parental reports. All subjects received hepatitis B vaccine at 0, 1, and 6 months of age following the national vaccination schedule of Taiwan. Results: The immunogenicity after the third dose was high for each vaccine antigen in both groups, and the vaccines had low reactogenicity. Statistical analysis showed no differences in the immune responses to the fully liquid DTaP-IPV-Hib vaccine compared with those to the DTaP-IPV plus Hib control vaccines, notably the anti-PRP (polyribose ribitol phosphate capsular polysaccharide) response, with 97-99% of infants having concentrations ≥1.0 μg/mL. Approximately 95% of all infants developed seroprotective levels of anti-hepatitis B surface antigen (HBs) antibodies (≥10 mIU/mL). Conclusions: Both combination vaccines had similar high immunogenicity for each antigen, and both were well tolerated. Thus, inclusion of a Haemophilus influenzae type b conjugate vaccine in the combination did not result in clinically significant decrease in the PRP response or increase reactogenicity. The fully liquid pentavalent vaccine has the advantages of not requiring reconstitution and of administration as a single injection.
KW - Acellular pertussis
KW - Fully liquid combination vaccine
KW - Haemophilus influenzae type b
KW - Pentavalent vaccine
UR - http://www.scopus.com/inward/record.url?scp=33847201507&partnerID=8YFLogxK
U2 - 10.1016/j.ijid.2005.10.014
DO - 10.1016/j.ijid.2005.10.014
M3 - 文章
C2 - 16762579
AN - SCOPUS:33847201507
SN - 1201-9712
VL - 11
SP - 129
EP - 136
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
IS - 2
ER -
