A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 263
- 试验地点
- 26
- 主要终点
- Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine
研究概览
简要总结
This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months
排除标准
- •Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
- •History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
- •Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination
结局指标
主要结局
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine
时间窗: One month after vaccination
Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Percentage of Participants With Prespecified Local Reactions
时间窗: Seven days after vaccination
Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (\>7.0 cm; \>14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.
Percentage of Participants With Prespecified Systemic Events
时间窗: Seven days after vaccination
Systemic events (any fever \>= 38 degree celsius \[C\], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as \>=38 to \<=39 degree C; \>39 to \<=40 degree C; \>40 degree C. Vomiting: mild (1-2 times/day ); moderate (\>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (\>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.
次要结局
- Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine(Up to 7 days before vaccination)
- Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine(Four to seven days after vaccination)
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine(Up to 7 days before vaccination)
- Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine(One month after vaccination)
- Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine(One month after vaccination)
- Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine(One month after vaccination)