To evaluate the Safety and Immunogenicity of a single dose â??Dengue Tetravalent Vaccine in healthy subjects.
- Registration Number
- CTRI/2017/02/007923
- Lead Sponsor
- Panacea Biotec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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
of 3 years
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
AND
--Subject is willing to avoid pregnancies up to 180 days post vaccination by use of an effective method of contraception or abstinence
AND
--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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: <br/ ><br>â?¢Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency <br/ ><br> <br/ ><br>Timepoint: Safety: <br/ ><br>â?¢Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to DEN1, DEN2, DEN3, and DEN4 viruses for each subject at Study Day 0, 28, and 90 post vaccination. <br/ ><br>â?¢Determination of the seroconversion rate (for subjects with preexisting antibodies) and seropositivity rate (for all subjects) by PRNT50 test to DENV-1, DENV-2, DENV-3, and DENV-4 viruses on Study Days 28 and 90 post vaccination <br/ ><br>Timepoint: Day 0, 28 and 90