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.”
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of all adverse events
研究概览
简要总结
The studywill be conducted after obtaining written informed consent from the subjects.Incase of pediatrics and adolescent subjects; parents or Legally AcceptableRepresentative (LAR) would sign the ICF. The subjects will undergo medicalscreening during pre-study visit (Visit 1). Screening will include completeclinical evaluation (medical history, general examination, record of height,weight and vital signs).
Enrolledadult subjects will receive a single dose of 0.5 ml of vaccine and pediatric& adolescent subjects will receive a single dose of 0.25 ml of vaccine (Day0) by intramuscular injection on the lateral aspect of arm in the deltoidmuscle. Blood sample will be collected for pre-immunization titers beforevaccination. Safety evaluation will be done for 3 hours on the vaccination day.Subjects will then be followed up using standardized diary card for 28 dayspost-vaccination for untoward AE/ADR and the same will be recorded in the CRF.At visit 3 (day 28+7), blood sample will be collected post-immunization titers.Clinical safety evaluation will also be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 64.00 Year(s)（—）
- 性别
- All
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
- •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.
- •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.
结局指标
主要结局
Incidence of all adverse events
时间窗: Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
SAEs during the study period
时间窗: Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
Common Solicited local and systemic reactions
时间窗: Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
Unsolicited AEs (including abnormal laboratory value)
时间窗: Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
次要结局
- Proportion/percentage of subjects achieving significant immune response against all three components of Influenza vaccine, 4 weeks after single dose of vaccination.(Visit 1)