A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze Dried IP) of M/s Cadila Healthcare Limited compared to a marketed Varicella vaccine in healthy paediatric subjects aged 1 to 12 years
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 256
- Locations
- 5
- Primary Endpoint
- Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study
Study Overview
Brief Summary
This is a randomized, single blind, parallel group, multicentre, non-inferiority phase II / III clinical trial to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited compared to Variped Vaccine Live I.P. (Oka / Merck strain, Manufactured by Merck (USA) in healthy paediatric subjects aged 1-12 years. Two hundred and fifty six subjects will be randomized to receive either Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited or Variped Vaccine Live I.P. (Oka / Merck strain, Manufactured by Merck (USA) according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine IgG antibody titres to Varicella Zoster virus using gpELISA kit manufactured by The Binding Site Group Ltd, UK (VaccZymeTM). The primary efficacy end point will be the Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study. The study will be conducted in sequential manner wherein subject aged >6-12 years will be enrolled before subjects aged 1-6 years.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy paediatric subjects of either sex aged 1 year to 12 years
- •Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child
- •Parents/guardians with adequate literacy to fill the diary cards.
Exclusion Criteria
- •Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin
- •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
- •Subjects with a history of convulsions, seizures, other central nervous system diseases, severe disease of haematopoietic system, cardiovascular system, liver or kidney
- •Subjects with an acute febrile illness at the time of randomization
- •A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
- •Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned during the study period
- •Subjects with any other clinically significant concurrent illness affecting immune response after vaccination.
Outcomes
Primary Outcomes
Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study
Time Frame: 42 days following vaccination
Secondary Outcomes
- Sero-conversion rate at the end of the study for Varicella in the two groups(42 days following vaccination)