A Phase 1, Prospective, Randomized, Two-Arm, Active-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Serum Institute of India’s 21-valent Pneumococcal Conjugate Vaccine (SIIPCV21) in Healthy Indian Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Safety and Tolerability following IM injection of SIILPCV21 vaccine versus Active Comparator for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events, SAEs.
研究概览
简要总结
This is a Phase 1 Safety, Tolerability and Immunogenicity trial in healthy Indian adults. The study is based on the objective that intramuscular administration of SIIPCV21 in healthy Indian participants will be safe, well tolerated and immunogenic. On successful completion, this early safety study will lead to later phase, safety and immunogenicity trials in the target population, i.e. adult, children, and infants, aimed at licensure of SIIPCV21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •Pneumococcal vaccine naive adult who is 18–49 years of age (both inclusive).
- •Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator may affect the safety of the participant or the trial endpoints.
- •Participant should be capable and willing to give voluntary written informed consent prior to inclusion in the trial.
- •Able to comprehend and comply with trial requirements and procedures and be able and willing to complete participant diary.
- •Male participants who are sexually active or married and female participants who are sexually active or married and are of childbearing potential should be willing to follow effective birth control methods for duration of the trial.
排除标准
- 未提供
结局指标
主要结局
Safety and Tolerability following IM injection of SIILPCV21 vaccine versus Active Comparator for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events, SAEs.
时间窗: Solicited adverse events (local and systemic) during the 7 day follow-up period post vaccination. | Unsolicited adverse events up to 28-Day follow-up period post vaccination. | SAEs during the entire trial period.
次要结局
- Functional antibodies will be measured by OPA & IgG conc. by ELISA will be evaluated for all serotypes contained in SIIPCV21.(Immunogenicity:)
研究者
Dr Nithya Gogtay
Seth GS Medical College & KEM Hospital