CTRI/2014/03/004497已完成3 期
A phase III, observer-blind, randomized, multicountry, non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline Biologicalsâ?? quadrivalent seasonal influenza candidate vaccine GSK2321138A (FLU D-QIV), administered intramuscularly in children 6 to 35 months of age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
- •Written informed consent obtained from the parent(s) /LAR(s) of the subject.
- •Subjects in stable health as determined by medical history and clinical examination before entering into the study.
排除标准
- •Child in care
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
- •Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
- •Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period
- •Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination
- •Any contraindication to intramuscular injection
- •Acute disease and/or fever at the time of enrolment.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study
- •Additional criteria for children >= 12 months of age:
- •-Prior receipt of any licensed varicella vaccine or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.
- •NOTE: For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.
- •-Any history of hepatitis A or varicella diseases.
- •Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:
- •-Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted
研究者
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