A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine - Catch-up study

Wyeth Research Division of Wyeth Pharmaceuticals Inc0 个研究点目标入组 355 人开始时间: 2007年3月29日最近更新: 2022年4月19日

试验速览

暂无简介。

•1. Aged from 7 months to <72 months, at time of enrollment.
•2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
•3. Healthy child 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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 pneumococcal vaccines.
•4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
•5. Known or suspected immune deficiency or suppression.
•6. History of culture-proven invasive disease caused by S pneumoniae.
•7. Major known congenital malformation or serious chronic disorders.
•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 monoclonal antibodies) in the last 3 months.
•10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
•11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc