To assess Immunogenicity And Safety Of Live Attenuated Varicella Vaccine Of Novo Medi Sciences Pvt. Ltd In Healthy Subjects
- Registration Number
- CTRI/2023/12/060869
- Lead Sponsor
- ovo Medi Sciences Pvt Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 424
1. Healthy subjects of either sex aged 1 year to 60 years.
2. Informed consent/assent of the subject/parents/LAR and their
willingness to be followed up for entire study period.
3. Subject/Parents/LAR with adequate literacy to fill the subject diary
cards.
4. Female participants of reproductive potential must:
Have a negative urine pregnancy test prior to each study
vaccination (on the day the participant is vaccinated and
before vaccine is administered).
Agree to remain abstinent, or use (or have their partner use)
2 acceptable methods of birth control. Abstinence or 2
acceptable methods of birth control must be practiced or
used from the day of enrolment, throughout the duration of
the study, and continued until 3 months following the last
study vaccination.
Age of subject should be at least 12 completed months
1. Subjects with a history of anaphylaxis or serious reactions to other
vaccines,
2. Subjects with a history of previous varicella infection or vaccination,
or if they had been exposed#
to the disease within 30 days of trial
commencement.
3. Subjects with a history of convulsions, seizures, other central
nervous system diseases, severe disease of hematopoietic
system, cardiovascular system, liver or kidney
4. Subjects with an acute febrile illness at the time of randomization
5. Any other vaccine administration within 30 days of initiation of the
study or planned during the study period.
6. A history of serious chronic illness, major congenital defects,
immunosuppression (immunosuppressive illness or therapy)
7. Subjects who have received blood, blood products or
immunoglobulins during the preceding 6 months or have planned.
during the study period.
8. Subjects with any other clinically significant concurrent illness
affecting immune response after vaccination.
#Close contact (family member or neighbour) with a diagnosed case of vericella infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Sero-conversion rate at 6 weeks post vaccination for children & at 6 weeks <br/ ><br>post dose 2 for adolescents/adults in test & reference arm. <br/ ><br>2.Geometric mean titre of IgG antibodies to Varicella Zoster virus at 6 weeks <br/ ><br>postvaccination for children and at 6 weeks post dose 2 for adolescents/adults in <br/ ><br>test and reference arm. <br/ ><br>Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method 1.4- Fold Seroconversion (antibody rise) rate at 6 weeks post vaccination for children & <br/ ><br>at 6 weeks post dose 2 for adolescents/adults in test and reference arm. <br/ ><br>2.Geometric mean fold rise (GMFR) from day 0 (pre-vaccination) to 6 weeks post <br/ ><br>vaccination for children and to 6 weeks post dose 2 for adolescents/adults. <br/ ><br>Timepoint: 6 weeks