Journal Article

Immunogenicity and Safety Results of a Randomized, Three-Arm, Phase IV Clinical Trial of Concomitant Administration of Typhoid Vi Conjugate Vaccine with Measles and Rubella Vaccine in Healthy Infants

Faridi, Mohammad Moonis Akbar, Maithal, Kapil, Elaiyaraja, Manickam, Desai, Samir, Rao, Songa Narayana, Kunnathamman, Radhakrishnan, Mankar, Sanjay Vasant, Mahajan, Manish, Mittal, Ravindra, Dutta, Trayambak, Preeti, Godatwar, Deshmukh, Bhaskar Jedhe, Daultani, Pavankumar, Hanumante, Neeta, Verma, Nishant, Kansagra, Kevinkumar, Patil, Mahantesh, Sarangi, Lisa, Parmar, Deven V., Ambike, Deepali, Nanoti, Girish, Mitra, Monjori

2025

Overview

Typhoid fever, measles, and rubella continue to contribute significantly to childhood morbidity and mortality in India. In line with WHO recommendations for co-administration of Typhoid Conjugate Vaccine (TCV) and measles–rubella (MR) vaccine at 9 months of age, this phase IV, randomized, open-label, multicenter clinical trial was conducted to assess their immunological compatibility and safety when administered concomitantly. A total of 900 healthy Indian infants aged 9–10 months were randomized into three groups: Group A received TCV and MR vaccine concomitantly; Group B received MR on Day 0 and TCV on Day 28; Group C received TCV on Day 0 and MR on Day 28. Subjects were followed for 6 months after concomitant/last vaccination. Seroconversion rates (SC) in Groups A/B/C at Day 28 were 90.2%/75.3%/89.5% for anti-Vi; 80.4%/75.2%/77.7% for anti-measles, and 87.7%/84.0%/85.2% for anti-rubella antibodies. By study end, SC for anti-Vi was 87.1%/71.6%/83.0%, while SC for anti-measles and anti-rubella reached ~90% and ≥98%, respectively, across all groups. Geometric mean titers increased significantly for all antigens, with no evidence of immunological interference. Safety assessments showed adverse events in 23.9%/32.0%/32.7% participants in Group A/B/C. Most adverse events were mild, and only one serious adverse event was reported. These findings support the co-administration of TCV and MR vaccine as a safe and effective strategy.

• Publisher: MDPI AG,Multidisciplinary Digital Publishing Institute (MDPI)
• Subject: Adverse events / Age / Antibodies / Antibodies, Bacterial - blood / Antibodies, Viral - blood / Antigens / Children / Clinical trials / concomitant vaccination / Demographic aspects / Dosage and administration / Enrollments / Female / Health aspects / Health care / Healthy Volunteers / Humans / Immunogenicity / Immunogenicity, Vaccine / Immunology / India / Infant / Infants / Male / Measles / Measles - immunology / Measles - prevention & control / Measles Vaccine - administration & dosage / Measles Vaccine - adverse effects / Measles Vaccine - immunology / Measles-mumps-rubella vaccine / measles–rubella vaccine / Morbidity / Polysaccharides, Bacterial - administration & dosage / Polysaccharides, Bacterial - immunology / Prevention / public health vaccination / Risk factors / Rubella / Rubella - immunology / Rubella - prevention & control / Rubella Vaccine - administration & dosage / Rubella Vaccine - adverse effects / Rubella Vaccine - immunology / Salmonella / Schedules / Seroconversion / Testing / Typhoid / typhoid conjugate vaccine / Typhoid fever / Typhoid Fever - immunology / Typhoid Fever - prevention & control / Typhoid-Paratyphoid Vaccines - administration & dosage / Typhoid-Paratyphoid Vaccines - adverse effects / Typhoid-Paratyphoid Vaccines - immunology / Vaccination / Vaccines / Vaccines, Combined - administration & dosage / Vaccines, Combined - immunology / Vaccines, Conjugate - administration & dosage / Vaccines, Conjugate - adverse effects / Vaccines, Conjugate - immunology