Phase I Clinical Trial of SII Yellow Fever Vaccine

An Open-Label, Randomized, Active Controlled, Phase I Clinical Study to Assess the Safety and Tolerability of SII Yellow Fever Vaccine in Healthy Adults.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027594

Enrollment

Registered

2020-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Stamaril: Live attenuated Yellow Fever Virus (17D-204 Strain) not less than 1000 IU/dose produced in specified pathogen-free chick embryos Intervention2: SII Yellow Fever Vaccine : Liv

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy adult male or non-pregnant female participants aged between 18-45 years. 2.Normal health as determined by medical history, clinical examination and laboratory assessment. 3.Participants willing to adhere to the protocol requirements and to provide written informed consent 4.Availability for clinical follow up through period of the study. 5.Female participants with negative pregnancy test during screening and prior to vaccine administration and agree to avoid pregnancy during participation in the study.

Exclusion criteria

Exclusion criteria: 1.Fever or any acute infection at time of immunization(Temporary exclusion criteria). 2.A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances. 3.Travel to a YF endemic area [Africa or South America including participants who plan to travel to these areas prior to completion of the study]. 4.Known history of infection with YF, dengue fever, TBE, JE, or West Nile Virus (WNV) 5. Positive ELISA for YF virus antibodies. 6. Woman who is pregnant or breast feeding.

Design outcomes

Primary

Measure	Time frame
1) Occurrence of immediate adverse events. 2) Occurrence of solicited local and systemic reactions 3) Occurrence of unsolicited adverse events. 4) Occurrence of serious adverse events.Timepoint: within 60 minutes within 10-day post vaccination follow-up period within 28 days post- vaccination within 90 days post -vaccination	—

Secondary

Measure	Time frame
GMTs of YF neutralizing antibody levels. Timepoint: at baseline,10,14 & 28 days of vaccination	—

Countries

India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Pvt Ltd

drpsk@seruminstitute.com020-26602384

Outcome results