Study on Yellow Fever Vaccine developed by Serum Institute of India Pvt. Ltd. for comparison of safety and immunogenicity with other vaccine (STAMARIL) In Healthy Infants

Phase 3

Recruiting

• Conditions: Yellow Fever

• Registration Number: PACTR202206910703861
• 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: 2022-04-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2216

Inclusion Criteria

1. Healthy infants as established by medical history and clinical examination
2. Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age)
3. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
4. Intend to remain residing in the study area throughout study participation
5. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants 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 by the prospective participant [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, measles, mumps, rubella, Neisseria meningitidis serogroup A, 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, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.
6. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit
7. Presence of significant malnutrition (weight-for-height z-score < -3SD)
8. Known or suspected impairment of immunological function based on medical history and physical examination
9. 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
10. Have a history of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5mg/kg/day of prednisolone
or equivalent) or other immune modifying drugs including the use of glucocorticoids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified