A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 Concomitantly Administered With Seasonal Influenza Vaccine in Healthy Subjects 50 Years of Age and Older
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,390
- 试验地点
- 25
- 主要终点
- For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of opsonophagocytic activity (OPA) geometric mean titers (GMT) in evaluable participants
研究概览
简要总结
This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥50 years of age (inclusive) at the time of randomization into the study.
- •Able and willing to complete the informed consent process.
- •Available for clinical follow-up through the last study visit at 7 months after the first study vaccination.
- •In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator.
- •Willing to have blood samples collected and used for research purposes.
- •Able to provide proof of identity to the satisfaction of the study site personnel completing the enrollment process.
- •Female subjects of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test at Screening and immediately prior to each vaccination and agree to use acceptable contraception, if heterosexually active. Female subjects who are not abstinent from heterosexual intercourse must agree to consistently practice contraception at least 7 days prior to vaccination and through their last study visit. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method ([use condoms with or without spermicide] or have undergone a vasectomy) from Day 1 through their last study visit. Note: A history of amenorrhea for at least 12 months without an alternative medical cause is required for a female to be considered postmenopausal in the study.
- •Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
排除标准
- •History of IPD or pneumococcal pneumonia (either confirmed or self-reported) at any age.
- •Previous receipt of a licensed or investigational pneumococcal vaccine at any age.
- •Previous receipt of an influenza vaccine from the current season; receipt of any influenza vaccine (licensed or investigational) within 6 months prior to Day 1; or receipt/planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
- •Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- •Planned or actual administration of any licensed vaccine within 30 days prior to Day
- •Body temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (participant may be rescreened).
- •Current diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
- •History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
- •History of Guillain-Barré syndrome.
- •Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
- •Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
- •Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
- •Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to Day
- •Receiving immunosuppressive therapy.
- •Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent >10 mg/day) within 14 days of study vaccinations. Note: Receipt of a ≥14-day course of systemic corticosteroids equivalent to ≤10 mg/day is permitted, as are inhaled, nebulized, topical, intra-articular, and intrabursal corticosteroids.
- •History of malignancy ≤5 years before to Day 1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
- •Employee of, or first-degree relative of any person employed by the Sponsor, the contract research organization (CRO), the Investigator, study site personnel, or site.
研究组 & 干预措施
VAX-31 + SIV
Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1.
干预措施: Seasonal Influenza Vaccine (SIV) (Flublok) (Biological)
VAX-31 + SIV
Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1.
干预措施: Placebo (Biological)
Placebo + SIV
Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1.
干预措施: 31-valent pneumococcal conjugate vaccine (Biological)
Placebo + SIV
Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1.
干预措施: Seasonal Influenza Vaccine (SIV) (Flublok) (Biological)
Placebo + SIV
Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1.
干预措施: Placebo (Biological)
VAX-31 + SIV
Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1.
干预措施: 31-valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of opsonophagocytic activity (OPA) geometric mean titers (GMT) in evaluable participants
时间窗: 1 Month after VAX-31 vaccination
For each of the strains in SIV, the ratio (co-administration group to sequential administration group) of hemagglutination inhibition (HAI) GMT in evaluable participants
时间窗: 1 Month after SIV administration
Percentage of participants reporting solicited local adverse events (AE) within 7 days after Day 1 and Month 1 vaccination (redness, swelling, and pain at injection site) in each group
时间窗: 7 days after each vaccination
Percentage of participants reporting solicited systemic AE within 7 days after Day 1 and Month 1 vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each group
时间窗: 7 days after each vaccination
Percentage of participants reporting unsolicited AE within 1 month after Day 1 and Month 1 vaccination in each group
时间窗: 7 days after each vaccination
Percentage of participants reporting NOCI, MAAE, and SAE within 6 months after last vaccination in each group
时间窗: 6 Months after last vaccination
次要结局
- For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of IgG geometric mean concentrations (GMC) in evaluable participants(1 month after VAX-31 administration)