Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in 11-12 Year Old Children, Previously Vaccinated With DTPa-HBV-IPV/Hib Vaccine in Study 217744/031
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 11
- 主要终点
- Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
研究概览
简要总结
This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.
详细描述
Subjects who participated in the primary study 217744/031 (NCT01457495) will be invited at the age of 11-12 years to participate in this follow-up study.
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
- 11 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
- •Written informed consent obtained from the parent or Legally Acceptable Representative of the subject.
- •Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
- •Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative (s).
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study 217744/031 (NCT01457495).
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
排除标准
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Child in care.
- •Use of any investigational or non-registered product drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
- •Receipt of hepatitis B (containing) vaccine after vaccination in the primary study 217744/031 (NCT01457495).
- •History of hepatitis B disease.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
研究组 & 干预措施
Infanrix-hexa/Engerix-B Group
Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
干预措施: Engerix™-B (Biological)
Infanrix-IPV+Hib/Engerix-B Group
Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
干预措施: Engerix™-B (Biological)
结局指标
主要结局
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
时间窗: One month after a challenge dose of Engerix-B vaccine
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
次要结局
- Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL(Before and one month after a challenge dose of Engerix-B vaccine)
- Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL(Before and one month after a challenge dose of Engerix-B vaccine)
- Number of Subjects With an Anamnestic Response to a Challenge Dose(Before and one month after a challenge dose of Engerix-B vaccine)
- Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL(Before the challenge dose of Engerix-B vaccine)
- Number of Subjects Reporting Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine)
- Number of Subjects Reporting Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(After the challenge dose of Engerix-B vaccine up to the study end)