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Clinical Trials/CTRI/2024/03/063471
CTRI/2024/03/063471
Recruiting
Phase 2/3

A Phase 2/3 Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL in Adults

Dr Prasad Kulkarni MD5 sites in 1 country580 target enrollmentStarted: March 15, 2024Last updated:
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Overview

Phase
Phase 2/3
Status
Recruiting
Sponsor
Dr Prasad Kulkarni MD
Enrollment
580
Locations
5
Primary Endpoint
To demonstrate the non-inferiority between the SII-Yellow Fever vaccine and Stamaril with respect to seroconversion rates (four fold rise to baseline PRNT50 titres) post-vaccination
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The study is designed as a multi center, double-blind, randomized clinical study to compare safety and immunogenicity of SII yellow fever vaccine with STAMARIL in healthy adults. 

The participants will be screened after informed consent and those eligible will be enrolled.

A total of 580 participants will be randomized to the two groups in a ratio of 1:1 and will receive either a single dose of SII Yellow Fever Vaccine or STAMARIL via subcutaneous route.

During the entire study, a participant will have three scheduled visits – Screening, Vaccine administration on Day 0, and post-vaccination visits on Day 28 (+14), 180 (+28).

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Male or female volunteers aged ≥ 18 years
  • •Healthy volunteers as determined by medical history and clinical examination
  • •Participants willing to adhere to the protocol requirements and to provide informed consent.
  • •Intend to remain residing in study area throughout study participation
  • •Female participants of childbearing potential having a negative pregnancy test within 24 hours prior to IP administration and agreeing to practice.

Exclusion Criteria

  • •Fever Axillary Temperature more than 37.5 C or any clinically significant acute infection at time of vaccination Temporary exclusion criteria participants may be reassessed for eligibility at least 48 hours after the last recorded fever
  • •Previous history of infection with yellow fever, and other flaviviruses dengue fever, tick-borne-encephalitis, Japanese encephalitis, West Nile virus, zika virus, etc.
  • •Previous vaccination against yellow fever, TBE, JE, or dengue fever.
  • •A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.
  • •Receipt of any immunoglobulin therapy and or blood products in the past 60 days or planned administration until completion of Day 28 visit.
  • •Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period.
  • •Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit
  • •Pregnant or lactating women
  • •Requirement of Yellow Fever vaccination certificate for travelling purpose
  • •Major congenital or genetic defect.

Outcomes

Primary Outcomes

To demonstrate the non-inferiority between the SII-Yellow Fever vaccine and Stamaril with respect to seroconversion rates (four fold rise to baseline PRNT50 titres) post-vaccination

Time Frame: PRNT50 titres will be measured at baseline pre-vaccination and post-vaccination at Day 28

Secondary Outcomes

  • safety, solicited and unsolicited events(solicited till day 10 post vaccination and unsolicited day 28 post vaccination and SAE till day 180 post vaccination)

Investigators

Sponsor
Dr Prasad Kulkarni MD
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Prasad Kulkarni

Serum Institute of India Pvt Ltd

Study Sites (5)

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