A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults Aged 18 Years and Over
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2,364
- 试验地点
- 7
- 主要终点
- Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
研究概览
简要总结
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over. To assess the effect of MVA-NP+M1 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine (QIV) in adults
详细描述
This is a Phase 2b, multicentre, randomised, single-blind study in up to 6000 adults to compare the efficacy, safety and immunogenicity of MVA-NP+M1 when given as an adjunct to a standard, licensed adult dose of QIV. The study will be conducted on an outpatient basis and will run over two consecutive influenza seasons. It is aimed to recruit 2200 participants in Season 1 and 2800-3800 participants in Season 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults aged 18 years and over
- •Receipt of a standard-dose licensed influenza QIV vaccine on the day of, or within 28 days prior to, randomisation
- •A female participant is eligible for this study if she is not pregnant or breast feeding and one of the following:
- •Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year)
- •Of childbearing potential but agrees to practice effective contraception 8 weeks post-vaccination and has a negative urine pregnancy test pre-vaccination. Acceptable methods of contraception include one or more of the following:
- •i. Male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant ii. Implants of levonorgestrel iii. Injectable progestogen iv. An intrauterine device with a documented failure rate of <1% v. Oral contraceptives vi. Double barrier methods including diaphragm or condom vii. Abstinence as long as it is line with the usual and preferred lifestyle of the participant
- •Participant is willing and has capacity to provide written informed consent for participation in the study (in the Investigator's opinion)
- •Able and willing (in the Investigator's opinion) to comply with all study requirements
- •Willing to allow the Investigators to discuss the participant's medical history with their healthcare provider
- •Present and able to visit the clinic in the event of an ILI episode during the influenza season
排除标准
- •Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigator, would either put the participant at risk because of participation in the study, or may influence the result of the study
- •Receipt of any investigational product within 6 months prior to study, or prior participation in a clinical study of any Influenza vaccine and agreement not to participate in another clinical study for the duration of study follow-up
- •Prior receipt of an investigational vaccine likely to impact on interpretation of the study data
- •Active infection with HIV, Hepatitis B or Hepatitis C (from patient history or medical records)
- •History of severe allergic reactions (e.g. anaphylaxis)
- •History of auto-immune disease e.g. Guillain-Barré syndrome
- •Not willing to comply with study procedures
- •Immunosuppressed or taking immunosuppressive medications
- •Use of warfarin or other blood thinning medications (aspirin is acceptable)
- •Tattoos or birthmarks at the vaccination site
- •Participant bruises easily, has haematoma or keloid scarring
- •Receipt of a licenced inactivated vaccine (e.g. pneumococcal vaccine) within 2 weeks prior to vaccination
- •Receipt of an off licensed live vaccine (e.g. herpes zoster vaccine) within 4 weeks prior to vaccination
研究组 & 干预措施
MVA-NP+M1
Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.)
干预措施: MVA-NP+M1 (Biological)
Saline Placebo
Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%)
干预措施: Saline (Drug)
结局指标
主要结局
Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
时间窗: 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) in line with official Australian influenza season.
The measure used reverse transcription polymerase chain reaction (RT-PCR) on deep nasal/mid-turbinate swab samples to record confirmed cases of influenza. If influenza symptoms are experienced at any time during the Follow Up period, after the vaccination, participants will attend the clinic on two occasions, the first as soon as possible and at least within 72 hours of the onset of symptoms for deep nasal swabs to be taken. Both swabs must be taken within 96 hours of symptom onset. The incidence rate of laboratory confirmed influenza using RT-PCR will be estimated for each vaccine group. The 95% CI for the incidence rate will be estimated by mid-p exact method. The difference in incidence rate between vaccine groups will be compared by Fisher's exact method.
次要结局
- Number of Participants With Immunogenic Response (Immunogenicity of MVA-NP+M1 in Adjunction With Licensed QIV as Assessed Via Titres of Influenza-specific Neutralizing Antibodies)(Day 28 and Week 26)
- Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary(210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019))
- Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs)(7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October))
- Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary(210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019))
- Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC(210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019))
- Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells)(Day 28 and Week 26)