A Phase 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13 valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants

Pfizer Inc, 235 East 42nd Street, New York NY100170 个研究点目标入组 200 人开始时间: 2010年8月17日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•Group 1 Preterm infants:
•1.Male or female infant born at < 37 weeks of gestation (GA as determined by the investigator).
•2.Chronological age = 42 to = 98 days (approximately 2 months) at the time of enrollment.
•3.Otherwise healthy preterm 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 study participation.
•5.Available for the entire study period and whose parent/ legal guardian can be reached by telephone.
•Group 2 Term infants:
•1.Male or female infant born at = 37 weeks of gestation (GA as determined by the investigator).
•2.Chronological age = 42 to = 98 days (approximately 2 months) at the time of enrollment.
•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 study participation.
•5.Available for the entire study period and whose parent/ legal guardian can be reached by telephone.
•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, Hib conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
•2.A previous anaphylactic reaction or allergy to any vaccine or vaccine-related component.
•3.Contraindication to vaccination with any routine pediatric vaccines.
•4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
•5.History of culture-proven invasive disease caused by S pneumoniae.
•6.Known or suspected immune deficiency or immune suppression.
•7.Major known congenital malformation or serious chronic disorder.
•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 disorder.
•9.Receipt of any other investigational vaccines, drugs, or medical devices within 28 days before inclusion and the first study vaccination.
•10.Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
•11.Major illness or conditions that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in, and completion of, the study, or could preclude the evaluation of the subject’s response.

发起方

Pfizer Inc, 235 East 42nd Street, New York NY10017