None listed
Conditions
Interventions
Intervention1: Dengue Tetravalent Vaccine: Attenuated (Recombinant, Lyophilized). The Vaccine is to be reconstituted with diluent (Sterile Water for Injection) before administration.
Single dose of 0.
Sponsors
Panacea Biotec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy subjects in step wise two cohorts will be enrolled for the study: Cohort 1 subjects >= 18 to Cohort 2 subjects >= 02 to 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 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 Timepoint: Safety: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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 Timepoint: Day 0, 28 and 90 | — |
Countries
India
Contacts
Public ContactDr Lalitendu Mohanty
Panacea Biotec Ltd
Outcome results
None listed