A Multicentric, Sero-epidemiological study to assess the neutralizing antibodies titer against respiratory syncytial virus (RSV-A and RSV-B) among the adult population across India.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- To assess the baseline levels of neutralizing antibodies against RSV (RSV-A And RSV-B) in overall study participants across India.
研究概览
简要总结
The study will be conducted at multiple centres across different regions of India (north, south, east, west and central). This will increase the generalizability of the findings to the broader Indian population. The study will involve collecting and analyzing blood samples (serology) to measure the levels of neutralizing antibodies against RSV-A and RSV-B. The study will assess the antibody levels at a single point in time (not longitudinally). This would provide a “snapshot” of the immune status of adults in different regions of India. This is a single visit study. Each participant will be involved for few hours on a single day during the study. All study participant related activities will be performed on one single day
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Individuals aged 18-49 with any of these comorbid conditions: COPD, bronchial asthma, cardiovascular diseases and diabetes mellitus b) Individuals age greater than or equal to 50 years irrespective of presence of comorbid conditions.
- •Participant or legally acceptable representative (LAR) able to provide written informed consent to participate in the study.
排除标准
- •Any confirmed or suspected immuno-compromised condition based on medical history and physical examination (no laboratory testing required)
- •Pregnant & lactating females or actively breast feeding.
- •Females with positive urine pregnancy test at time of screening.
- •History of vaccination against RSV
- •Recipient of blood, plasma or platelet transfusions during last 6 months
- •History of organ transplantation.
- •History lower respiratory tract infection including RSV in last 3 months.
结局指标
主要结局
To assess the baseline levels of neutralizing antibodies against RSV (RSV-A And RSV-B) in overall study participants across India.
次要结局
- To assess the baseline levels of neutralizing antibodies against RSV (RSV-A And RSV-B) in study participants by region, comorbid conditions, age & gender across India.
研究者
Dr Hemant Joshi
Cipla Ltd Vikhroli Mumbai