[Immunogenicity and safety of DTaP-IPV//PRP-T combined vaccine in infants in China].
Zhonghua Liu Xing Bing Xue Za Zhi
; 32(8): 808-15, 2011 Aug.
Article
en Zh
| MEDLINE
| ID: mdl-22093474
ABSTRACT
OBJECTIVE:
The aim of this study was to demonstrate the immunogenicity and safety of diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV//PRP-T) combined vaccine compared with commercially available DTaP (diphtheria, tetanus and pertussis), Haemophilus influenzae type b (Hib), tetanus conjugate and IPV monovalent vaccine.METHODS:
Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIM(TM)) vaccinated at 2, 3, 4 months of age or 3, 4, 5 months of age respectively; Group C was commercially available DTaP. Hib tetanus conjugate (Act-HIB(TM)) and IPV (IMOVAX PolioTM(TM)) vaccines vaccinated at 3, 4, 5 months of age. All groups received booster dose at 18 to 20 months of age, with antibody titers tested. Non-inferiority analysis was demonstrated in terms of seroprotection/seroconversion rates between Group A, Group B respectively and Group C. Safety information was collected after each vaccination to assess the safety of investigational vaccines.RESULTS:
The non-inferiority of DTaP-IPV//PRP-T combined vaccine vaccinated at 2, 3, 4 or 3, 4, 5 months of age versus DTaP, Hib tetanus conjugate and IPV vaccine was demonstrated for all vaccine antigens in both primary and booster phases in terms of seroprotection/seroconversion rates. DTaP-IPV//PRP-T combined vaccine was well tolerated. The rate of solicited/unsolicited severe adverse reactions was very low and similar to the control vaccines.CONCLUSION:
DTaP-IPV//PRP-T combined vaccine was highly immunogenic with good safety profile in Chinese infants, which was comparable to the commercially available control vaccines.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vacuna Antipolio de Virus Inactivados
/
Vacunas Conjugadas
/
Vacunas contra Haemophilus
/
Vacunas contra Difteria, Tétanos y Tos Ferina Acelular
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Infant
/
Male
Idioma:
Zh
Revista:
Zhonghua Liu Xing Bing Xue Za Zhi
Año:
2011
Tipo del documento:
Article
País de afiliación:
China