A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 704
- 试验地点
- 38
- 主要终点
- Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
研究概览
简要总结
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
详细描述
This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and immunogenicity of Menveo after a single vaccination in healthy individuals who were vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals. Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to participation to this clinical trial.
Subjects will be randomised into one of the two different blood draw schedules according to a 1:1 ratio.
- Blood draws at Day 1, Day 4 and Day 29
- Blood draws at Day 1, Day 6 and Day 29
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
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals of 15 through 55 years of age on the day of informed consent or assent.
- •Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine.
- •Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
- •Individuals who can comply with study procedures including follow-up.
- •Males Or Females of non-childbearing potential Or
- •Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
排除标准
- •Each subject must not have:
- •History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR History of any meningococcal vaccine administration.
- •Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
- •Progressive, unstable or uncontrolled clinical conditions.
- •Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
- •Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws.
- •Abnormal function of the immune system resulting from:
- •Clinical conditions.
- •Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
- •Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
- •Received immunoglobulins or any blood products within 180 days prior to informed consent.
- •Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
- •Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
- •Study personnel as an immediate family or household member.
- •Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
- •Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
结局指标
主要结局
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
时间窗: At Day 29
Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers\< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo \&,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W \& Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo \& Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
次要结局
- Number of Subjects Reporting Solicited Local and Systemic AEs(From Day 1 (6 hours) through Day 7 after vaccination)
- Number of Subjects Reporting Other Indicators of Reactogenicity(From Day 1 (6 hours) through Day 7 after vaccination)
- Number of Subjects Reporting All Unsolicited AEs(From Day 1 through Day 29 after vaccination)
- Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C(At day 1(pre-vaccination) , day 4, day 6 and day 29)
- Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A(At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)(Within 30 minutes after vaccination)
- Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C(At day 1(pre-vaccination) , day 4, day 6 and day 29)
- Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y(At day 1(pre-vaccination), day 4, day 6 and day 29)
- Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W(At day 1(pre-vaccination), day 4, day 6 and day 29)
- Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y(At day 1(pre-vaccination) , day 4, day 6 and day 29)
- hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.(At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29)
- Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)(From Day 1 through Day 181 (entire study period))
- Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A(At day 1(pre-vaccination), day 4, day 6 and day 29)
- Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y(At Day 4 and Day 6)
- Within Group hSBA Geometric Mean Ratios (GMRs)(At Day 4, Day 6, Day 29 compared to Day 1)
- Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W(At day 1(pre-vaccination), day 4, day 6 and day 29)