NCT03189745已完成3 期
A PHASE IIIB, OPEN STUDY TO EVALUATE THE IMMUNOGENICITY, REACTOGENICITY AND SAFETY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER HEALTHY SUBJECTS AGED 11-17 YEARS RECEIVED EITHER MENACWY-TT VACCINE (NIMENRIX(REGISTERED)) OR MENCEVAX ACWY(REGISTERED).
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination
研究概览
简要总结
This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- •Written informed consent obtained from the subject prior to performing any study specific procedure.
- •Healthy male or female subjects as established by medical history and history-directed physical examination before entering into the study.
- •Having completed the vaccination in study MenACWY-TT-036 (109069) as per protocol.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral ovariectomy or post-menopause.
- •Please refer to the GLOSSARY OF TERMS for the definitions of menarche and post-menopause.
- •Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk for pregnancy 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 (for females only), and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will be 10 mg/day prednisone, or equivalent. Inhaled, topical, and intra-articular steroids are allowed.
- •Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2).
- •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 vaccine/product (pharmaceutical product or device).
- •Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the MenACWY-TT-036 study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus infection, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted.
- •Acute disease and/or fever at the time of vaccination.
- •Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be vaccinated at the discretion of the investigator.
- •Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Male subjects able to father children who are planning to discontinue contraceptive precautions.
结局指标
主要结局
Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination
时间窗: 1 month after booster vaccination
Serogroups included: Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). The rSBA titer levels greater than or equal to (\>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer \>=1:8. Data reported below is including both seropositive and seronegative participants.
次要结局
- rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination(Before booster vaccination, 1 month after booster vaccination)
- Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination(Before booster vaccination, 1 month after booster vaccination)
- Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination(Before booster vaccination, 1 month after booster vaccination (Vac))
- Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination(Before booster vaccination, 1 month after booster vaccination)
- Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination(Within 4 days post booster vaccination (Day 0 to Day 3))
- Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination(31 days after booster vaccination (Day 0 to Day 30))
- Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination(Within 31 days after booster vaccination (Day 0 to Day 30))
- Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination(10 years after primary vaccination)
研究者
研究点 (2)
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