A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 324
- 试验地点
- 8
- 主要终点
- Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination
研究概览
简要总结
The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female older than 50 years of age
- •Eligibility must be determined by medical history, physical exam and clinical judgment
- •Able to complete an electronic diary
- •Available for duration of study
- •Negative pregnancy test for subjects in group 2 age 50 to 64 years
- •Practice abstinence or use reliable birth control if age is 50 to 64 years
排除标准
- •History of allergic reaction to any vaccine
- •Previous vaccination with licensed or experimental pneumococcal vaccine
- •S. pneumonia infection within past 5 years before investigational product administration
- •Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
- •Receipt of plasma products or immunoglobulins within 60 days
- •Bleeding conditions or diathesis
- •Receipt of investigational product within 28 days before study entry
- •Other severe acute or chronic medical or psychiatric condition
结局指标
主要结局
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination
时间窗: One month (28 to 42 days) after vaccination
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5\*limit of detection (LOD \[8\]) = (titer of 4) for the purpose of calculating the OPA GMT.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination
时间窗: Within 14 days after vaccination
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters \[cm\]), Moderate (5.1 to 10.0 cm), Severe (\>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination
时间窗: Within 14 days after vaccination
Systemic events reported using electronic diary. Fever-Any:\>=38 degrees Celsius (C), Mild (M):\>=38 to \<38.5 degrees C, Moderate(Mod):\>=38.5 to \<39 degrees C, Severe (S):\>=39 to \<=40 degrees C, Potentially life threatening:\>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:\>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:\>=6/d. All reports of fever \>40 degrees C were confirmed as data entry errors.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Baseline up to 1 Month (28 to 42 days) after vaccination
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.
次要结局
- Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination(One month (28 to 42 days) after vaccination)
- Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination(Pre-vaccination to 1 month (28 to 42 days) after vaccination)