EUCTR2009-013346-83-FI进行中（未招募）不适用
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 3 to 17 Years - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine
Sanofi Pasteur SA0 个研究点开始时间: 2009年7月1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
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) Provision of Informed Consent Form signed by the subject's the parent(s)/legal
- •representative (and by an independent witness if required by local regulations).
- •In addition, provision of Assent Form signed by subjects aged 6 to 11 years, and
- •of Informed Consent Form signed by subjects =12 years.
- •2) Subject and parent/guardian are able to attend all scheduled visits and to comply
- •with all trial procedures
- •3) Aged 3 to 17 years on the day of inclusion
- •4) For a female of childbearing potential, use of an effective method of
- •contraception or abstinence for at least 4 weeks prior to the first vaccination,
- •until at least 4 weeks after the last vaccination
- •At V05 (M8), for antibody persistence assessment (amendment 2)
- •5) Having received two injections of the 15 µg HA vaccine or of the
- •3.8 µg HA + AF03 vaccine
- •6) Addendum 1 to Informed Consent Form has been signed by the subject's
- •parent(s)/guardian(s) (and by an independent witness if required by local
- •regulations). In addition, provision of addendum 1 to Assent Form signed by
- •subjects aged 6 to 11 years, and of addendum 1 to Informed Consent Form
- •signed by subjects =12 years
- •At V06, for subjects eligible for the Ab persistence evaluation who will receive the TIV (amendment 3):
- •7) Addendum 2 to Informed Consent Form has been signed by the subject and/or subject’s parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 2 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 2 to Informed Consent Form signed by subjects =12 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Participation in another clinical trial investigating a vaccine, drug, medical device,
- •or medical procedure in the 4 weeks preceding the first trial vaccination
- •2) Planned participation in another clinical trial during the present trial period
- •3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •4) Planned receipt of any vaccine prior to the Day 42 blood sample
- •5) Receipt of blood or blood-derived products in the past 3 months, which might
- •interfere with assessment of the immune response
- •6) Known or suspected congenital or acquired immunodeficiency; or receipt of
- •immunosuppressive therapy such as anti-cancer chemotherapy or radiation
- •therapy within the preceding 6 months; or long-term systemic corticosteroid
- •therapy (prednisone or equivalent for more than 2 consecutive weeks within the
- •past 3 months)
- •7) Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or
- •Hepatitis C as reported by parents/legal representative
- •8) Known systemic hypersensitivity to any of the vaccine components, or history of
- •a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
- •containing any of the same substances
- •9) Thrombocytopenia, contraindicating IM vaccination as reported by parents/legal
- •representative
- •10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
- •contraindicating IM vaccination
- •11) Deprived of freedom by an administrative or court order, or in an emergency
- •setting, or hospitalized involuntarily
- •12) Chronic illness that, in the opinion of the Investigator, is at a stage where it might
- •interfere with trial conduct or completion
- •13) Employee of the Investigator or study center, with direct involvement in the
- •proposed study or other studies under the direction of that Investigator or study
- •center, as well as family members of the employees or the Investigator
- •14) Previous participation in a trial investigating a vaccine with the swine-origin
- •A/H1N1 influenza strain
- •15) Confirmed infection with the swine-origin A/H1N1 influenza strain (different
- •from the seasonal strain) in 2009
- •16) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection
- •on the day of vaccination, according to Investigator judgment
- •17) Receipt of any allergy shots and/or seasonal allergy medication in the 7-day
- •period prior to enrollment (vaccination), or scheduled to receive any allergy shots
- •and/or seasonal allergy medication in the 7-day period after enrollment
- •(vaccination)
- •18) Known pregnancy, or a positive urine pregnancy test
- •19) Currently breastfeeding a child
- •20) Current alcohol abuse or drug addiction that might interfere with the ability to
- •comply with trial procedures
- •At V05 (M8), for antibody persistence assessment (amendment 2)
- •21) Subjects who received, in the context of a pandemic immunization program,
- •another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal
研究者
相似试验
进行中（未招募）
1 期
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly subjects - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccinePreventive vaccination in healthy subjects aged 18 years and over against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)EUCTR2009-013344-37-FRSanofi Pasteur SA450
进行中（未招募）
不适用
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccinePreventive vaccination in healthy subjects aged 6 to 35 months against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)EUCTR2009-013858-32-FISanofi Pasteur SA
进行中（未招募）
1 期
Evaluation of immunogenicity and safety of two formulations of human rotavirus (HRV) vaccine, in healthy infants starting at age 6-12 weeks.Rotarix is indicated to prevent infants against gastroenteritis (GE) due to rotavirus (RV).MedDRA version: 19.0Level: LLTClassification code 10039232Term: Rotavirus gastroenteritisSystem Organ Class: 100000004862EUCTR2016-000598-19-FIGlaxoSmithKline Biologicals1,600
进行中（未招募）
1 期
Concomitant administration of the Novavax vaccine and a 20-valent pneumococcal conjugate vaccine in adults aged =60 yearsVaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults (age >60 years). Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the new, Omicron-adapted Novavax (NVX XBB.1.5) vaccine and a 20-valent pneumococcal conjugate vaccine results in lower immunogenicity than the administration of either alone.EUCTR2022-004118-12-ATMedical University of Vienna256
已完成
2 期
Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy InfantsInfections, StreptococcalNCT01616459GlaxoSmithKline953