Study to Compare Safety and Immunogenicity of Yellow Fever Vaccine of Serum Institute of India with with STAMARI

Phase 3

Recruiting

• Conditions: Yellow Fever

• Registration Number: PACTR202206719871582
• Lead Sponsor: Serum Institute of India Pvt Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1824

Inclusion Criteria

1. Male or female volunteers aged = 1 year
2. Healthy volunteers as determined by medical history and clinical examination
3. Participants willing to adhere to the protocol requirements and to provide informed consent for participants = 18 years of age. For participants < 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants >12 years but <18 years of age in Kenya)
4. Intend to remain residing in study area throughout study participation
5. Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post-vaccination. *Females can be considered not of childbearing potential only if they are pre-menarche and less than 12 years of age, or with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause. **Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label
6. Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.
7. Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study

Exclusion Criteria

1. Fever (> 37.5°C) or any clinically significant acute infection at time of
vaccination [Temporary exclusion criteria – participants may be rescreened
at least 48 hours after the last recorded fever]
2. Use of systemic (oral or parenteral) antibiotics or antiviral agents within
the past 7 days. [Temporary exclusion criteria – participants may be rescreened
at least 7 days after last dose of antibiotics or antiviral agents]
3. Use of traditional/herbal local medications and treatments in the past 7
days [Temporary exclusion criteria – participants may be re-screened
at least 7 days after last consumption of traditional/herbal local
medications and treatment]
4. Previous history of laboratory confirmed infection with yellow fever,
and other flaviviruses e.g., dengue fever, tick-borne-encephalitis
(TBE), Japanese encephalitis (JE), West e virus (WNV), zika virus,
etc.
5. Previous vaccination against yellow fever, TBE, JE, or dengue fever.
6. Receipt of any vaccine within past 28 days or planned vaccination until
completion of Day 28 visit
7. Known or suspected impairment of immunological function based on
medical history and physical examination.
8. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic,
renal, gastrointestinal, hematological, endocrine, immunological,
dermatological, neurological, cancer, or autoimmune disease) as
determined by medical history and / or physical examination which
would compromise the participant’s health or is likely to result in
nonconformance to the protocol
9. History of chronic administration (defined as more than 14 consecutive
days) of immunosuppressant (> 0.5 mg/kg/day of prednisolone or
equivalent) or other immune modifying drugs including the use of
glucocorticoids. The use of topical/inhaled/per nasal glucocorticoids
will be permitted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage seroconversion on Day 28 post-vaccination<br>Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline;Geometric mean titre GMT;Percentage of participants showing seroprotection

Secondary Outcome Measures

Name	Time	Method
Immediate adverse events in all participants;Post-vaccination reactogenicity (in reactogenicity cohort) <br>1. Solicited local adverse events<br>2. Solicited systemic adverse events;All unsolicited adverse events in all participants;Serious adverse events in all participants