CTRI/2010/091/000020已完成3 期
Bridging Study on Safety and Immunogenicity of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
Sanofi Pasteur SA0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) 18 years of age and above on the day of inclusion.
- •2) Provision of informed consent form signed by the participant. If the participant is illiterate, an independent witness is required to sign the consent form.
- •3) Participant able to attend all scheduled visits and comply with all trial procedures.
- •4) For a female, if sexually active, 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.
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 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 trial vaccination.
- •4) Planned receipt of any vaccine during the study period (except 6 months follow up).
- •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) Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C as reported by the participant / parent or legal representative and/or based on medical history.
- •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) Known thrombocytopenia, contraindicating intramuscular vaccination.
- •10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular 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) History of influenza infection in 2009-2010.
- •16) 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).
- •17) Known pregnancy, or a positive urine pregnancy.
- •18) Currently breastfeeding a child.
- •19) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures.
- •Temporary contraindication to be resolved before vaccination:
- •20) Febrile illness (temperature >= 38.0°C) or moderate or severe acute illness/infection on the day of vaccination.
研究者
相似试验
已完成
1 期
Reactogenicity and Immunogenicity of the pentavalent vaccine DPT-HB+Hib. Schedule 2-4-6 months.Prophylaxis against infections diseases: Diphtheria, Tetanus, B. pertussis, H. influenzae type b and hepatitis B.RPCEC00000103Center for Genetic Engineering and Biotechnology (CIGB).624
尚未招募
1 期
ABDALA Clinical StudyCOVID-19SARS-CoV2Disease PreventionCoronavirus InfectionsSARS VirusCoronaviridae InfectionsBetacoronavirusRPCEC00000346Center for Genetic Engineering and Biotechnology (CIGB), in Havana
尚未招募
1 期
Safety and immunogenicity of VCN7-T in infants of 2 and 3 months. Phase I/II.Pneumococcal diseaseHealthy VolunteersPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsRPCEC00000243Finlay Institute Vaccine880
已完成
不适用
Study for effects of Haemophilus Influenzae type b conjugate vaccine in childreChildren Haemophilus Meningitis.Meningitis due to Haemophilus influenzaeIRCT201008084536N1Masoondarou Co.50
已完成
1 期
Investigating of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Related to Human Papillomavirus Type 16IRCT20190504043464N1Iran University of Medical Sciences200