A phase III open-label study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine as a 3-dose primary immunization course at 2, 3 and 4 months of age in infants in Vietnam. - 10PN-PD-DIT-066

GlaxoSmithKline Biologicals0 个研究点目标入组 300 人开始时间: 2015年5月13日最近更新: 2015年7月10日

适应症

试验速览

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•Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
•Written and signed or thumbprinted informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 300
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
•Acute disease and/or fever at the time of enrolment.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
•Hypersensitivity to latex.
•Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.

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