A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity, and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children

Wyeth Pharmaceuticals Inc. (a Pfizer company)0 个研究点目标入组 373 人开始时间: 2012年2月20日最近更新: 2012年3月20日

适应症

试验速览

暂无简介。

•All Participants
•1. Male or female infants and children between the ages of = 42 days (6 weeks) and <5 years of age at the time of enrollment.
•2. Must be available for the entire study period and the parent/legal guardian can be reached by telephone.
•3. Must be determined to be in good health by medical history, physical examination, and the judgment of the investigator or a medically qualified designee.
•4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
•Immunogenicity Study Participants
•1. Parent/legal guardian is willing to complete a supplemental informed consent form permitting blood to be taken from the subject.
•2. Subject lives in the Bethel, Alaska area.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 373
•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

•All Participants
•1. A previous anaphylactic reaction to any vaccine or vaccine-related component.
•2. Contraindication to vaccination with pneumococcal vaccine.
•3. Bleeding diathesis or condition associated with prolonged bleeding time that would
•contraindicate intramuscular injection.
•4. Major known congenital malformation.
•5. Significant neurological disorder or significant evolving disorders such as
•encephalopathy, hydrocephalus, a history of seizures including uncontrolled
•epilepsy/infantile or other significant disorders. Does not include resolving syndromes
•due to birth trauma such as Erb palsy or simple febrile seizures.
•6. Participation in another investigational or interventional trial. Participation in purely
•observational studies is acceptable.
•Immunogenicity Study Participants
•1. Receipt of blood products or gamma globulin within the last 3 months.
•2. Known or suspected immune deficiency or suppression.

发起方

Wyeth Pharmaceuticals Inc. (a Pfizer company)