A Phase 3, Open Label, Trial, Evaluating the safety, tolerability and Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Children Previously Partially Immunized with Prevenar

Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点开始时间: 2008年12月29日最近更新: 2012年3月19日

试验速览

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•1.Group 1. Male or female subject between the age of = 140 and = 196 days of age at time of enrollment. Group 2. Male or female subject between the age of = 336 and = 392 days of age at time of enrollment
•2.The last dose of Prevenar must have been received at least 42 days before enrollment. Written documentation endorsed by a health professional showing that one dose of Prevenar and one dose of the NIP vaccinations have been given.
•3.Child is determined to be in good health by medical history, physical examination, and judgment of the investigator.
•4.Child is available for the entire study period and his/her parent/legal guardian can be reached by telephone
•5.Parent/legal guardian must be able and willing to comply with all study procedures.
•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 other than Prevenar.
•2.A contraindication to vaccination with pneumococcal conjugate vaccine.
•3.Child had a previous anaphylactic reaction or allergy to any vaccine or vaccine-related component.
•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.Received blood products or gamma globulin, in the last 3 months.
•10.Participation in another interventional or investigational trial. Participation in purely observational studies is acceptable.
•11.Infant or toddler who is a direct descendant (e.g. child or grandchild) of the study site personnel.
•12.Any of the following 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

Wyeth Research Division of Wyeth Pharmaceuticals Inc.