EUCTR2014-004498-17-Outside-EU/EEA进行中（未招募）不适用
A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Trivalent Subunit Inactivated Influenza Vaccine (Agriflu™) in Healthy Children and Adolescents 3 to 17 Years of Age. - Safety and Immunogenicity of Trivalent Subunit Inactivated Vaccine Administered to Healthy Children
ovartis Vaccines and Diagnostics0 个研究点目标入组 1,764 人开始时间: 2014年11月13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
- 1,764
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. Males and females aged 3 to 17 years (inclusive) on the day of enrollment.
- •2. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
- •3. Documented consent provided by parents or legal guardians after the nature of the study was explained to them according to local regulatory requirements.
- •4. For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study was explained to them in terms they could understand better.
- •5. Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1386
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Parents/legal guardians and individuals who had to provide assent, who were not able to comprehend and follow all required study procedures for the whole period of the study.
- •2. Parents/legal guardians and individuals who had to provide assent, who could not consent to the retention of the subject’s serum samples after study completion.
- •3. Individuals with behavioral/cognitive impairment/psychiatric disease that, in the opinion of the investigator, interfered with the subject's ability to participate in the study.
- •4. Individuals with history/any illness that, in the opinion of investigator, interfered with the results of the study or posed additional risk to the subjects due to study participation
- •5. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, any excipients, and eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propriolactone, or nonoxynol-9
- •6. History of any serious disease, such as:
- •b. history of serious chronic diseases (cardiac, renal, hepatic, metabolic (including diabetes mellitus), rheumatologic (including autoimmune disease such as rheumatoid arthritis), neurologic (including history of atypical febrile seizure or history of Guillain-Barré disease), and hematologic (including bleeding diathesis).
- •c. history of underlying medical condition such as inborn errors of metabolism, failure to thrive, broncho-pulmonary dysplasia, or any major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome).
- •7. Known/suspected impairment/alteration of immune function, included:
- •a. chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
- •b. received immuno-stimulants within 60 days prior to Visit 1
- •c. received parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
- •d. HIV infection or HIV-related disease
- •e. Heritable immunodeficiency
- •f. Abnormalities of splenic or thymic function
- •8. Pregnant or breast-feeding female
- •9. Any positive or indetermined pregnancy test
- •10. If female, ?of childbearing potential?, sexually active, and did not use any of the
- •?acceptable contraceptive methods for at least 2 months prior to study entry
- •a. Of childbearing potential was defined as status post onset of menarche and not surgically sterile
- •b. Acceptable birth control methods were defined as one or more of the following:
- •i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
- •ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
- •iii. Intrauterine device (IUD)
- •iv. Monogamous relationship with vasectomized partner. Partner had
- •to be vasectomized for at least six months prior to the subject’s
- •study entry
- •11. If female of childbearing potential and sexually active, refused to use an
- •?acceptable contraceptive method? during the first 3 weeks after vaccination
- •12. If female of childbearing potential, refused to submit for pregnancy testing prior to study vaccination
- •13. Received influenza vaccine within 6 months prior to Visit 1
- •14. Laboratory-confirmed or suspected influenza
研究者
相似试验
尚未招募
3 期
Comparison Study of Immunogenicity and Safety of SIBP’s Measles, Mumps and Rubella (MMR) Vaccine versus WHO prequalified GSK Measles, Mumps and Rubella (MMR) VaccinePACTR202405741158761Shanghai Institute of Biological Products Co. Ltd SIBP1,200
已完成
3 期
A clinical trial to evaluate efficacy and safety of two different formulations of topical Calcipotriol in patients with mild to moderate plaque psoriasis.CTRI/2018/08/015360Cadila Pharmaceuticals Limited278
招募中
3 期
CVIA 092Short Title: Phase 3 EuTCV Trial in AfricaTyphoid feverPaediatricsPACTR202112680671189EuBiologics Co Ltd3,255
进行中（未招募）
1 期
A Clinical Study to Assess the Safety and Immunogenicity of the Tetanus, Diphtheria and Pertussis Vaccine SIIPL Tdap in Comparison with Boostrix® in Healthy Adults, Adolescents and ChildreEUCTR2019-002706-46-DEVakzine Projekt Management GmbH1,332
进行中（未招募）
1 期
A study to evaluate the immunogenicity and safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a pediatric population aged 5 through to 17 years of ageProphylaxis for influenza virus infectionMedDRA version: 19.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-004133-25-Outside-EU/EEASeqirus GmbH2,222