Ritabrata Kundu1, Ambrose Kumar Kandulna2, Uma Nayak3, Sanjay Kumar Jangid4, T Ramesh Babu5, Rajesh Vukkala6, Shrikant Sharma7, Vimal Kant Goyal8, Pavankumar Daultani9, Ravindra Mittal10, Pradip Patel11. 1. Department of Pediatrics, Institute of Child Health, Kolkata, West Bengal, India. 2. GCS Medical College, Hospital and Research Centre, Ahmedabad, Gujarat, India. 3. GMERS Medical College and General Hospital, Vadodara, Gujarat, India. 4. Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha, India. 5. Gandhi Medical College and Hospital, Secunderabad, Telangana, India. 6. Indo-US Superspeciality Hospital, Hyderabad, Telangana, India. 7. SMS Medical College and Hospital, Jaipur, Rajasthan, India. 8. Panchsheel Hospital Pvt Ltd, New Delhi, India. 9. Department of New Product Development, Cadila Healthcare Ltd, Ahmedabad, Gujarat, India. Correspondence to: Dr Pavankumar Daultani, Senior Manager, Department of New Product Development, Cadila Healthcare Ltd., Sigma CommerZone, Opp. ISCON Temple BRTS Stand, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad 380 015, Gujarat, India. drpavandaultani@gmail.com. 10. Department of New Product Development, Cadila Healthcare Ltd, Ahmedabad, Gujarat, India. 11. Vaccine Manufacturing, Cadila Healthcare Ltd, Ahmedabad, Gujarat, India.
Abstract
OBJECTIVE: To compare the immunogenicity and safety of an investigational typhoid Vi conjugate vaccine (Test TCV) with a marketed typhoid Vi conjugate vaccine (Comparator TCV). DESIGN: Randomized, controlled trial. SETTING: Tertiary care and multispecialty hospitals. PARTICIPANTS: 240 healthy subjects of 6 months to 45 years. Pediatric (<18 years) subjects were enrolled after day 21 safety assessment of adult subjects. INTERVENTION: Participants received a single-dose of test TCV or comparator TCV at baseline and were followed up for 6 weeks post-vaccination. MAIN OUTCOME MEASURE: Primary variable was to demonstrate non-inferiority of the test TCV with the comparator TCV for seroconversion post-vaccination (³4-fold rise in antibody titre). Secondary variables were seroconversion in the adult and pediatric cohorts, and geometric mean titre of antibodies while the safety was based on reported adverse events. RESULTS: A total of 117 subjects (Adult-58, Pediatric-59) and 119 subjects (Adult-60, Pediatric-59) in test and comparator group, respectively completed the study. The seroconversion rate with test TCV (overall-94.8%, adult-96.6% and pediatric-93.1%) was non-inferior to comparator TCV (overall-91.6%, adult-91.7% and pediatric-91.5%). The geometric mean titres of antibodies (EU/mL) at baseline (test TCV: overall-7.6, adult-10.0, and pediatric-5.7; and comparator TCV: overall-8.0, adult-12.0, and pediatric-5.3) and at end of study (test TCV: overall-1121.0, adult-1411.0 and pediatric-891.1; and comparator TCV: overall-1104.0, adult-1199.0 and pediatric-1014.0) were also comparable between the groups (P>0.05 for all). The most common adverse event was injection-site pain followed by fever in both the groups. CONCLUSIONS: The immunogenicity and safety of test TCV is comparable to already marketed comparator TCV.
RCT Entities:
OBJECTIVE: To compare the immunogenicity and safety of an investigational typhoid Vi conjugate vaccine (Test TCV) with a marketed typhoid Vi conjugate vaccine (Comparator TCV). DESIGN: Randomized, controlled trial. SETTING: Tertiary care and multispecialty hospitals. PARTICIPANTS: 240 healthy subjects of 6 months to 45 years. Pediatric (<18 years) subjects were enrolled after day 21 safety assessment of adult subjects. INTERVENTION: Participants received a single-dose of test TCV or comparator TCV at baseline and were followed up for 6 weeks post-vaccination. MAIN OUTCOME MEASURE: Primary variable was to demonstrate non-inferiority of the test TCV with the comparator TCV for seroconversion post-vaccination (³4-fold rise in antibody titre). Secondary variables were seroconversion in the adult and pediatric cohorts, and geometric mean titre of antibodies while the safety was based on reported adverse events. RESULTS: A total of 117 subjects (Adult-58, Pediatric-59) and 119 subjects (Adult-60, Pediatric-59) in test and comparator group, respectively completed the study. The seroconversion rate with test TCV (overall-94.8%, adult-96.6% and pediatric-93.1%) was non-inferior to comparator TCV (overall-91.6%, adult-91.7% and pediatric-91.5%). The geometric mean titres of antibodies (EU/mL) at baseline (test TCV: overall-7.6, adult-10.0, and pediatric-5.7; and comparator TCV: overall-8.0, adult-12.0, and pediatric-5.3) and at end of study (test TCV: overall-1121.0, adult-1411.0 and pediatric-891.1; and comparator TCV: overall-1104.0, adult-1199.0 and pediatric-1014.0) were also comparable between the groups (P>0.05 for all). The most common adverse event was injection-site pain followed by fever in both the groups. CONCLUSIONS: The immunogenicity and safety of test TCV is comparable to already marketed comparator TCV.