CTRI/2011/05/001730已完成3 期
An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine (Split) of Changhchunchangsheng Life Sciences Ltd. In Pediatrics, Adolescent and Healthy Adults.? - Influenza (Split)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
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
- •Volunteers who are able and are willing to comply with the protocol and have signed IEC/IRB approved ?Informed Consent Forms (ICF)? voluntarily. Incase of pediatric and adolescent volunteers subject?s Legally Acceptable Representative have to sign ICF.?
- •Healthy male or non-pregnant, non-lactating female or pediatric or adolescent volunteers, ≥ 6 months of age or older on the day of inclusion and not older than 64 years.
- •Subjects with normal heath as determined by personal medical history, clinical
- •examination and laboratory examinations within the clinically acceptable normal range.
- •Volunteers who have not received influenza containing vaccines within five years.
- •Willing to give written informed consent and fulfill all study requirements.
- •Have a degree of understanding such that the subject can communicate intelligibly with the investigator and study coordinator.
- •Female volunteers of child bearing potential require a ?Negative Urine Pregnancy Test? and must be willing to practice acceptable method of contraception or surgically sterile during the study and 6 weeks after the completion of study.
排除标准
- •Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol.
- •Self-reported history of severe adverse event to any influenza vaccine.
- •Acute febrile disease within the 72 hours, or axillary temperature 37.5°C the day of inclusion, prior to vaccination (37.0°C)
- •Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
- •Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
- •Any vaccination within the 28 days preceding Visit 1 or scheduled between Visit 1 and Visit 4.
- •Receipt of blood or blood products within the 3 months preceding enrollment in the study.
- •Diabetes mellitus requiring pharmacological control.
- •Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for 2 weeks) or cancer therapy within the month preceding Visit 1 or ongoing
- •Immunoglobulin injection within the 3 months.
- •Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
- •Subject having received extracted pituitary hormones.
- •For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
- •Current use of alcohol or recreational drugs that may interfere with the subjects ability to comply with trial procedures.
- •Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- •Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
- •Volunteers planning to leave the area of study site before completion of the study.
研究者
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