A Phase 1, Observer-blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Number of participants with solicited administration site adverse events (AEs)
研究概览
简要总结
The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is an observer-blind study.
入排标准
- 年龄范围
- 42 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants' parent(s)/Legally acceptable representative [LAR(s)] who, in the opinion of the investigator, can and will comply with all protocol requirements.
- •Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior to performance of any study-specific procedure.
- •Participant is approximately 2 Months of Age [MOA (42 to 90 days, inclusive)] at time of first study intervention administration.
- •Healthy participants as established by medical history and clinical examination before entering the trial.
- •Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of >2.5 kg.
排除标准
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- •Hypersensitivity to latex.
- •History of microbiologically proven Invasive pneumococcal Disease (IPD).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Major congenital defects, as assessed by the investigator.
- •Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.
- •Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- •Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period.
- •Previous vaccination with any pneumococcal vaccine.
- •Planned administration/administration of any inactivated or otherwise non live vaccine in the period starting 14 days before and ending 14 days after each dose of study intervention administration or planned administration/administration of any live vaccine in the period starting 28 days before and ending 28 days after each dose of study intervention(s) administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention.
- •Receipt of blood or plasma products or immunoglobulins, since birth, or planned receipt during the trial up to 30 days after last study intervention administration.
- •Chronic administration of immune-modifying drugs and/or planned use of long-acting immune-modifying treatments at any time up to the end of the trial since birth. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day. Inhaled and topical steroids are allowed.
- •Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.
- •Any child of trial personnel or their immediate dependents, family, or household members.
- •Child in care.
研究组 & 干预措施
PCV20 Group
Participants receive three primary doses of PCV20 on Day 1, Day 61, Day 121 and a booster dose on Day 301.
干预措施: PCV20 (Combination Product)
Pn-MAPS30plus Group
Participants receive three primary doses of Pn-MAPS30plus on Day 1, Day 61, Day 121 and a booster dose on Day 301.
干预措施: Pn-MAPS30plus (Biological)
结局指标
主要结局
Number of participants with solicited administration site adverse events (AEs)
时间窗: Day 1 to Day 7
The AEs considered are tenderness, redness, and swelling.
Number of participants with solicited systemic adverse events (AEs)
时间窗: Day 1 to Day 7
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
Number of participants with unsolicited AEs
时间窗: Day 1 to Day 30
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
时间窗: Day 1 up to trial end (Month 16)
次要结局
未报告次要终点