EUCTR2009-017498-39-GB进行中（未招募）1 期
A follow-on, multi-centre, open-label, clinical, phase 3 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007)
- •2.Aged 39-44 months (inclusive) at time of enrolment.
- •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.
- •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
排除标准
- •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; eg, 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.
- •6.3.4Temporary exclusion criteria
- •1.In the event of systemic illness or fever > 38 degrees centigrade at the time of the visit, immunisation will be deferred and rearranged as appropriate when the participant is recovered.
- •2.Any live immunisation within 28 days prior to enrolment, or any other (non-live) vaccine within the 7 days prior to enrolment.Any immunisation within 28 days of enrolment.
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