None listed
Conditions
Interventions
Intervention1: SII TYPHOID CONJUGATE VACCINE (BIVALENT): SII Typhoid Conjugate Vaccine (Bivalent) is a bivalent conjugate vaccine manufactured by SIIPL that contains conjugated antigens from S. Typhi
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult male or female participants aged between 18-45 years [both inclusive] and normal Body Mass Index (18.50 to 24.99 kg/m2) [both inclusive] with minimum of 50 kg body weight. 2. Normal health as determined by medical history, clinical examination and laboratory assessment. 3. Participants willing to adhere to the protocol requirements and to provide written informed consent 4. Participants residing in and around the study area during the study participation period.
Exclusion criteria
Exclusion criteria: 1. A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the similar components. 2. Any serious adverse event with previous receipt of tetanus and/or diphtheria toxoid containing vaccines. 3. History of suspected / laboratory confirmed S. Typhi or S. Paratyphi A infection. 4. Previous vaccination for typhoid fever (either oral live attenuated or injectable vaccines). 5. Household contact with known exposure to an individual with laboratory confirmed S. Typhi or S. Paratyphi A. 6. Reactive serology for HIV, hepatitis B and hepatitis C viruses. 7. Positive RPR test. 8. History or presence of asthma, urticaria or other allergic reaction. 9. Experienced significant acute, or chronic infections requiring systemic antibiotic treatment within the past 14 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Immediate adverse events 2. Solicited local and systemic adverse events 3. Unsolicited adverse eventsTimepoint: 1. within 60 minutes post-vaccination 2. up to Day 8 post-vaccination 3. up to Day 29 post-vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| GMTs of anti-Vi specific IgG serum antibodies measured by ELISA at pre-vaccination, and post-vaccinationTimepoint: on Days 29 and 181.;GMTs of IgG anti-lipopolysaccharide serum antibodies measured by ELISA at pre-vaccination, and post-vaccinationTimepoint: on Days 29 and 181;GMTs of SBA for paratyphoid A antigen at pre-vaccination, and post-vaccinationTimepoint: on Days 29 and 181;Percentage of participants showing seroconversion for anti-Vi IgG antibody titres at post-vaccinationTimepoint: on Days 29 and 181 | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Pvt. Ltd.
Outcome results
None listed