A Phase I/II, Double Blind, Placebo controlled, Randomized, Multicenter, prospective study to evaluate the Safety and Immunogenicity of a single dose â??Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized)â?? in healthy subjects.

Panacea Biotec Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Healthy subjects in step wise two cohorts will be enrolled for the study:
•Cohort 1 subjects >= 18 to <= 60 years old
•Cohort 2 subjects >= 02 to <18 years old
•Subjects â??With previous exposure to dengueâ?? as well as â??Without previous exposure to dengueâ?? will be enrolled in both the Cohorts.
•2. Subject in good health, based on medical history, Clinical laboratory tests and physical examination.
•3. Willingness to participate throughout the study period
•Inclusion criteria for females:
•4.1 Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal (12 months of amenorrhea after the last menstrual period) or are pre-menarche girls)
•4.2 Female with child bearing potential is eligible if:
•-- Subject has used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination
•--Subject is willing to avoid pregnancies up to 180 days post vaccination by use of an effective method of contraception or abstinence
•--Subject has negative serum pregnancy test on the screening day and negative urine pregnancy test on the day of vaccination

•1.Breastfeeding woman
•2.Subjects who have any clinically significant chronic disease, which, in the opinion of the investigator would endanger the volunteerâ??s well-being or interfere with the evaluation of the study objectives.
•3.Known impairment of the immune function, including, but not limited to: Diabetes Mellitus, Cancer, Autoimmune diseases, asthma, Asplenia etc.
•4.Known seropositivity for HIV, hepatitis B, and hepatitis C reported by the subject.
•5.History of any Bleeding Disorder
•6. History of severe allergic reactions or anaphylaxis. History of allergy to any of the component of Investigational product.
•7. Any evidence of clinically significant acute illness or infection or fever within past 3 days of study participation (Screening).
•8.Any evidence of clinically significant

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