A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

Wyeth K.K. Research and Development Department0 个研究点目标入组 193 人开始时间: 2015年4月7日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1.Aged 2 to 6 months (defined as the first day the subject is 2 months of age to the last day the subject is 6 months of age) at time of enrollment.
•2.Available for entire study period and whose parent/legal guardian can be reached by telephone.
•3.Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
•4.Parent/legal guardian must be able to complete all relevant study procedures during subject participation. This includes the ability to understand and sign the informed conset form (ICF).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 193
•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

•1.Previous vaccination with licensed or investigational pneumococcal vaccine.
•2.A previous anaphylactic reaction to any vaccine or vaccine-related component.
•3.Contraindication to vaccination with a pneumococcal conjugate vaccine.
•4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
•5.Known or suspected immune deficiency or suppression.
•6.History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
•7.Major known congenital malformation or serious chronic disorder (eg, Down syndrome, diabetes, sickle cell anemia).
•8.Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
•9.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis) within the past 3 months.
•10.Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
•11.Infant who is a direct descendant (child, grandchild) of the study site personnel.
•12.Infant who is judged by the investigator to be ineligible for study enrollment

发起方

Wyeth K.K. Research and Development Department