Phase I Clinical Trial of SII Yellow Fever Vaccine

Phase 1

Completed

Registration Number: CTRI/2020/09/027594

Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

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 e Virus (WNV)

5. Positive ELISA for YF virus antibodies.

6. Woman who is pregnant or breast feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Occurrence of immediate adverse events. <br/ ><br> <br/ ><br>2) Occurrence of solicited local and systemic reactions <br/ ><br> <br/ ><br>3) Occurrence of unsolicited adverse events. <br/ ><br> <br/ ><br>4) Occurrence of serious adverse events.Timepoint: within 60 minutes <br/ ><br> <br/ ><br>within 10-day post vaccination follow-up period <br/ ><br> <br/ ><br> <br/ ><br>within 28 days post- vaccination <br/ ><br> <br/ ><br>within 90 days post -vaccination

Secondary Outcome Measures