A clinical study to assess the continued immunological existence of antibodies at 12, 24 and 36 months after receiving the primary dose.
- Conditions
- Preventive protection against Typhoid feverEncounter for immunization,
- Registration Number
- CTRI/2020/03/023712
- Lead Sponsor
- Biological ELimited
- Brief Summary
This is a multicentre phase-III follow-up study to assess the immunological persistence of anti-Vi IgG antibodies at or above 12, 24 and 36 months respectively. This follow up study is also designed to evaluate the immune response to a booster dose of respective typhoid Vi conjugate vaccine administered at 36 months in 6 months to 45 year old subjects who have participated in BECT053 study in both arms.
A total of 576 primed 6 months to 45-year-old subjects of either gender who have successfully completed participation in a previous phase-II/III study bearing No. BECT053 would be enroled in this study. A single booster dose of respective typhoid Vi conjugate vaccine would be administered at 36 months and subjects would be followed up to day 42+7 for safety and immunogenicity assessment.
The study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 576
- Healthy primed children, adolescents and adults of either gender between 6 months to 45 years (both inclusive) of age, who participated in a previous phase-II/III study bearing No.BECT053.
- Subjects who are willing to participate and who would be expected to comply with the requirements of the protocol.
- Written voluntarily given informed consent given by the subject or subject’s parent / legally acceptable representative prospectively.
- Subjects who did not receive a single dose of Typhoid conjugate vaccine in previous study bearing No. BECT053.
- Subjects for whom blood samples could not be collected either at baseline or at post vaccination period in the previous study bearing No. BECT053.
- Female subjects with UPT (Urine Pregnancy Test) positive at Visit 3 (pre-booster at Day 730).
- History of documented hypersensitivity to any component of the vaccine.
- History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- Receipt of any other investigational intervention or blood products in the last 3 months or anticipated during the course of the study.
- Any confirmed or suspected immunosuppressive or immune-deficient condition or receipt of systemic immunosuppressant or systemic corticosteroids in the last 3 months based on medical history and physical examination; 8.
- Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness.
- Any condition determined by the investigator likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number and percentage of subjects with anti-Vi IgG antibodies At or above 12, 24 and 36 months post primary vaccination.
- Secondary Outcome Measures
Name Time Method Number and percentage of subjects with anti-Vi IgG antibodies At day 42 post booster dose Geometric mean concentrations of anti-Vi IgG antibodies and proportion of subjects with ≥4-fold rise of antibodies At day 42 post booster dose Number and percentage of subjects with solicited adverse reactions during first 30 minutes of post booster vaccination observation period and for subsequent 7 consecutive days Number and percentage of subjects with unsolicited adverse events (AEs) during the follow up period until day 42 post booster vaccination »Number and percentage of subjects with medically attended and/or serious adverse events (SAEs), if any during the 42 days follow up period after booster vaccination.
Trial Locations
- Locations (9)
Father Muller Medical College & Hospital
🇮🇳Kannada, KARNATAKA, India
Gandhi Medical College and Hospital
🇮🇳Hyderabad, TELANGANA, India
Guru Teg Bahadur Hospital
🇮🇳East, DELHI, India
J.S.S. Hospital
🇮🇳Mysore, KARNATAKA, India
Jay Kay Lon Hospital attached to S.M.S. Medical College
🇮🇳Jaipur, RAJASTHAN, India
Kalinga Institute of Medical Sciences (KIMS)
🇮🇳Khordha, ORISSA, India
Oriana Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
PT. B D Sharma Post Graduate Institute of Medical Sciences & Hospital
🇮🇳Rohtak, HARYANA, India
Sant Dnyaneshwar Medical Education & Research Centre
🇮🇳Pune, MAHARASHTRA, India
Father Muller Medical College & Hospital🇮🇳Kannada, KARNATAKA, IndiaDr Pavan HegdePrincipal investigator09845088116pavanhegde@hotmail.com