NCT00192179已完成2 期
A Phase II, Prospective, Randomized, Double-Blind, Placebo, Controlled Trial, to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B Live Cold-Adapted Liquid Formulation (CAIV-T) in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Number of subjects with fever greater than or equal to 39.1C oral
研究概览
简要总结
A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.
详细描述
This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •who are aged 6 to less than 18 years at the time of enrolment
- •who, if female and is of child bearing potential is using reliable method of hormonal and/or non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL/ml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study.
- •N.B.lactating females are excluded from the study.
- •who are in good health as determined by medical history, physical examination and clinical judgement
- •whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
- •who, along with their parent(s)/legal guardian(s) will be available until completion of the study
- •whose parent(s)/legal guardian(s), can be reached by study staff for the post vaccination contacts(telephone, clinic or home visit)
排除标准
- •who along with their parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
- •with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease
- •with Down's syndrome or other known cytogenetic disorders
- •with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents
- •who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
- •have an immunosuppressed or an immunocompromised individual living in the same household
- •with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or placebo
- •who have a history of Guillain-Barre Syndrome (GBS)
- •for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study
- •who, in the two weeks prior to entry into the study, received a dose of influenza treatment (commercial or investigational)
- •who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study
- •who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational)
- •with asthma requiring regular medical follow up or hospitalization during the preceding year
- •with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results
- •Note: Pregnancy in any person who has regular contact with the subjects is not a contraindication to enrollment or ongoing participation of the subject in the study.
研究组 & 干预措施
CAIV-T
Experimental
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
干预措施: Cold-adapted influenza vaccine trivalent (CAIV-T) (Biological)
Placebo
Placebo Comparator
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
干预措施: Placebo (Biological)
结局指标
主要结局
Number of subjects with fever greater than or equal to 39.1C oral
时间窗: Days 0-7
次要结局
- Number of subjects with any reactogenicity(Day 0-7)
- Number of subjects with any adverse events(Days 0-7)
- Number of subjects with any serious adverse events(Days 0-21)
研究者
研究点 (6)
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