A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 7
- 主要终点
- Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.
研究概览
简要总结
This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent.
- •Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Infants whose parents or legal guardians can comply with study procedures including follow-up
排除标准
- •Previously received any meningococcal A, C, W and Y vaccines.
- •Previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth.
- •Progressive, unstable or uncontrolled clinical conditions.
- •A history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy.
- •Experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth
- •Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study.
- •Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
- •Any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- •Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study.
- •Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops).
- •Relatives of site research staff working on this study.
结局指标
主要结局
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.
时间窗: From Day 1 to Day 7 after each vaccination
Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age
时间窗: At 24 months of age (Visit 6)
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.
时间窗: Within 30 minutes of each vaccination
Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None \[\<10mm\], Any\[\>=10 mm\]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever\[ body temperature \>=38°C measured preferably via tympanic route\]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination
时间窗: From Day 1 to Day 7 after each vaccination
Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (\<10 mm), Any (\>=10 mm)
Number of Subjects With Serious AEs (SAEs)
时间窗: From Day 1 to Visit 6 (At 24 months of age)
Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age.
时间窗: At 24 months of age (Visit 6)
To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal
时间窗: From Day 1 to Visit 6 (at 24 Months of age)
An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)\] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age
时间窗: At 24 months of age (Visit 6)
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
次要结局
- Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age(At 13 months of age (Visit 5))
- Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age(At 13 months of age (Visit 5))
- hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age(At 24 months of age (Visit 6))
- Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age(At 13 months of age (Visit 5))
- rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age.(At 13 months of age (Visit 5))
- rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age(At 24 months of age (Visit 6))
- hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age(At 13 months of age (Visit 5))