Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year-Old Children Previously Vaccinated With a 2-Dose or 3-Dose Infants Series and Toddler Dose With Vaxelis® or INFANRIX® Hexa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 754
- 主要终点
- Percentage of Participants Responding to Pertussis Toxin
研究概览
简要总结
This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa
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
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study.
- •Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.
- •Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.
- •Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.
- •Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*.
- •Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*.
- •Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies.
- •Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.
- •Criteria 5 and 6 are temporary exclusion criteria. If a participant meets criteria 5 and/or 6 at the time of Visit 1, a further appointment is to be scheduled to reassess the participant's eligibility.
结局指标
主要结局
Percentage of Participants Responding to Pertussis Toxin
时间窗: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Fimbriae
时间窗: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)
时间窗: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer \>=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
时间窗: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Pertactin
时间窗: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
次要结局
- Geometric Mean Concentration of Antibodies to Pertussis Fimbriae(Day 1 (approximately 4 years after completion of the 2+1 schedule))
- Geometric Mean Concentration of Antibodies to HBsAg(Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule))
- Geometric Mean Concentration of Antibodies to Pertussis Toxin(Day 1 (approximately 4 years after completion of the 2+1 schedule))
- Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin(Day 1 (approximately 4 years after completion of the 2+1 schedule))
- Geometric Mean Concentration of Antibodies to Pertussis Pertactin(Day 1 (approximately 4 years after completion of the 2+1 schedule))