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임상시험 NCT01561768은(는) 인플루엔자에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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노바백스A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults 2상 500 백신
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT01561768은(는) 예방을(를) 알아보기 위한 연구였습니다. 이 연구는 인플루엔자에 대한 것이었으며, 완료 된 2상 중재연구이었습니다. 연구는 2012년 3월 1일에 시작되어 500명의 참여자와 함께 진행되었습니다. 노바백스이(가) 진행한 이 연구는 2013년 1월 1일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2013년 7월 18일에 갱신되었습니다.
간단한 개요
The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and G...더 보기
공식 제목
A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-64) Adults
질환명
인플루엔자기타 연구 식별자
- NVX 778.S205
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Group 1 | Novavax Quadrivalent vaccine Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid |
실험적Group 2 | Novavax Quadrivalent vaccine Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid |
실험적Group 3 | Novavax Quadrivalent vaccine Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid |
실험적Group 4 | Novavax Trivalent vaccine Trivalent Dose; intramuscular injection, deltoid |
실험적Group 5 | cTIV Preconfigured dose; intramuscular injection, deltoid |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses | Day 21 | |
Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine | 6 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults | Based on criteria of greater than or equal to 40% HAI seroconversion and greater than or equal to 70% of subjects with HAI titers greater than or equal to 1:40 post-vaccination. | Day 21 |
Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains | Based on comparison to a trivalent NovaFlu formulation tested at the 22.5ug of HA (per strain) dose level. | Day 21 |
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Healthy adult male or females, 18-64 years of age
- Willing and able to give informed consent prior to study enrollment
- Able to comply with study requirements
- Women who are not post-menopausal (≥ 50 years of age and at least one year post last menses) or surgically sterile must have a negative urine pregnancy test at vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD)
- Participation in research involving investigational product (drug/biologic/device) within 45 days before planned date of first vaccination
- History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed TIV (e.g., egg proteins) or polysorbate-80
- History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine
- Received any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within six months preceding the study vaccination
- Any know or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration)
- Presence of chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a "high-risk" category for influenza and/or its complications
- Known disturbance of coagulation
- Women who are breastfeeding or plan to become pregnant during the study
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting)
노바백스Department of Health and Human Services연락처 정보가 없습니다.
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