A follow-on, multicentre, open-label, clinical, phase IV trial to investigate the persistence of serotype-specific antibodies at 40 months of age in children who have received either the 7-valent or the 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age and assessing the immunogenicity of a 13-valent pneumococcal conjugate vaccine booster dose given at 40 months of age

John Radcliffe Hospital (UK)0 个研究点目标入组 100 人开始时间: 2010年6月11日最近更新: 2015年1月13日

适应症

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•Participants must meet the following conditions in order to be enrolled:
•1. Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study
•2. Aged 39 - 46 months (inclusive) at time of enrolment, either sex
•3. Available for entire study period and whose parent/legal guardian can be reached by telephone
•4. Healthy children as determined by medical history, physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator
•5. Parent/legal guardian must be able to complete all relevant study procedures during study participation

•Participants with any of the following conditions or characteristics will be excluded from study enrolment:
•1. Has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the Wyeth-sponsored PCV13 infant trial study (6096A1-007)
•2. A previous anaphylactic reaction to any vaccine or vaccine-related component
•3. Contraindication to vaccination with pneumococcal conjugate vaccine
•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 disorder
•8. Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder
•9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies, e.g., synagisB)
•10. Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable.
•11. Child who is a direct descendant (child, grandchild) of the study site personnel

发起方

John Radcliffe Hospital (UK)