Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose Quadrivalent, Influenza Vaccines, 2020-2021 Formulations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
研究概览
简要总结
Primary Objective:
To provide serum samples (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.
详细描述
Study duration per participant was approximately 28 days for participants 6 months to less than (<) 9 years of age, and 21 days for participants greater than or equal to (>=) 65 years of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls, depending on study Group.
The aim of study GRC00101 was to obtain serum samples for submission to CBER to aid in the influenza vaccine strain selection process. There were no outcome measures defined in the protocol; however, the number of collected samples was listed as an outcome for disclosure purposes since outcomes were mandatory for study registration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 84 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to <36 Months
Participants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28.
干预措施: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation (Biological)
Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to <9 Years
Participants aged 3 to <9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
干预措施: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation (Biological)
Group 3: Fluzone High-Dose Quadrivalent Influenza Vaccine: >=65 Years
Participants aged >=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
干预措施: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation (Biological)
结局指标
主要结局
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
时间窗: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.
Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
时间窗: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
次要结局
未报告次要终点