A Study To Evaluate Pneumococcal Antipolysaccharide Antibody Concentrations in Subjects That Participated in the Wyeth Prevenar Safety and Immunogenicity Study 0887X-101518

Wyeth, A Pfizer Company0 个研究点目标入组 335 人开始时间: 2015年4月6日最近更新: 2015年7月10日

适应症

试验速览

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•1. Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative has been informed of all pertinent aspects of the study.
•2. Male or female subjects who participated in and completed Wyeth study 0887X-101518.
•3. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
•4. Parent/legally acceptable representative is willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 335
•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. Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X-101518.
•2. History of culture-proven invasive disease caused by Streptococcus pneumoniae since the
•completion of Wyeth study 0887X-101518.
•3. Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X-101518.
•4. Receipt of any blood products, including immunoglobulin within 12 weeks before the study.
•5. Subjects related to investigational site staff members or subjects related to Pfizer employees directly involved in the conduct of the trial.
•6. Participation in other studies at the time of enrollment.
•7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that increased the risk associated with study participation or interfered with the interpretation of study results and, in the judgment of the investigator.

发起方

Wyeth, A Pfizer Company