EUCTR2006-001300-37-BE进行中（未招募）不适用
Immunogenicity and reactogenicity of the trivalent influenzasubunit vaccine Influvac® for the season 2006/2007. An open,baseline-controlled study in two groups of healthy subjects:adult subjects greater than or equal to 18 and less than or equal 60 years and elderly subjects greater than or equal to 61 yearsof age. - Influvac annual update 2006
Solvay Pharmaceuticals B.V.0 个研究点目标入组 120 人开始时间: 2006年5月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed and dated informed consent.
- •2. Healthy and aged greater than or equal to 18 and less than or equal to 60 years or greater than or equal to 61 years of age.
- •3. Mental health good enough to understand the study and the informed consent form and to fill in
- •the questionnaire.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the
- •2. Having fever and/or presenting with an acute infectious episode of the upper and/or lower
- •respiratory airways.
- •3. Having experienced a documented serious systemic reaction after previous influenza
- •vaccination.
- •4. Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other
- •disorders affecting the immune system, taking immunosuppressive medication (such as
- •systemic corticosteroids) including the four weeks preceding the start of the study (date of
- •informed consent), or having a disease in a terminal stage.
- •5. Having received vaccination against influenza within the previous six months before Visit 1.
- •Exclusion criteria only for female subjects aged greater than and equal to 18 and less than or equal to 60 years and of childbearing
- •6. Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
- •7. Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra
- •Uterine Device, double barrier method).
- •The rationale for the above exclusion criteria 1 and 3 is that of safety; exclusion criteria 2, 4 and 5
- •are necessary for eligibility, as they prevent interference with this study’s primary objective
- •(immunogenicity against hemagglutinin of the specified strains of influenza ; also see section 7.8);
- •and although allowed as per label, exclusion criteria 6 and 7 are standard for these clinical studies
- •due to administrative reasons.
研究者
相似试验
进行中（未招募）
不适用
Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2006/2007. An open, baseline-controlled study in two groups of healthy subjects: adult subjects greater than or equal to 18 and less than or equal 60 years and elderly subjects greater than or equal to 61 years of age. - Influvac annual update 2006Prophylaxis of influenza, especially in those who run an increased risk of associated complications.EUCTR2006-001300-37-DESolvay Pharmaceuticals B.V.120
进行中（未招募）
不适用
Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2005/2006. An open, baseline controlled study in twogroups of healthy subjects: adult subjects aged = 18 and =60 years and elderly subjects = 61 years of age.(Extension to protocol S206.3.010) - InvivacProphylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.EUCTR2005-003791-38-DESolvay Pharmaceuticals B.V.120
进行中（未招募）
不适用
Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2005/2006. An open, baseline controlled study in two groups of healthy subjects: adult subjects aged =18 and =60 years and elderly subjects =61 years of age. - InvivacEUCTR2005-000341-11-DESolvay Pharmaceuticqals B.V.120
进行中（未招募）
不适用
Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2007/2008. An open, baseline-controlled multi-centre study in two groups of healthy subjects: Adult subjects aged greater than or equal to 18 and less than or equal to 60 years and elderly subjects greater than 61 years of age. - Influvac Annual Update 2007/2008EUCTR2007-000875-40-DESolvay Pharmaceuticals B.V.120
进行中（未招募）
1 期
Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2007/2008. An open, baseline-controlled multi-centre study in two groups of healthy subjects: Adult subjects aged greater than or equal to 18 and less than or equal to 60 years and elderly subjects greater than 61 years of age. - Influvac Annual Update 2007/2008Prophylaxis of influenza.MedDRA version: 9.1Level: HLTClassification code 10022005Term: Influenza viral infectionsEUCTR2007-000875-40-BESolvay Pharmaceuticals B.V.120