None listed
Conditions
Interventions
Intervention1: Typhoid bi-valent conjugate vaccine: Subjects will receive single dose of 0.5 mL Typhoid bi-valent conjugate vaccine by intramuscular route in deltoid region in the upper arm. The subje
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male subjects of 18 to 50 years of age. 2.Judged to be in good health on the basis of reported medical history, physical examination, laboratory investigations and clinical judgement of the investigator. 3.Plans to remain in the study area for the entire length of the trial. 4.Subject is literate and has understood and provided written Informed Consent.
Exclusion criteria
Exclusion criteria: 1.Participation in any other clinical trial in the four weeks preceding the trial vaccination. 2.Subjects who have previously received any vaccines against typhoid fever. 3.Subjects who have a previously ascertained or suspected disease caused by S. Typhi or S. Paratyphi A. 4.Any household member having or exposed to an individual with laboratory confirmed S. Typhi or S. Paratyphi A. 5.Planned participation in any other clinical trial during the present trial period. 6.Subject who has a known history of allergy to any component of the vaccine. 7.Known or suspected primary or acquired disease of the immune system. 8.Receiving allergy immunotherapy or immunosuppressive therapy or systemic/oral corticosteroids. 9.History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, diabetes, hypertension, hematologic or hepatic dysfunction and autoimmune disease. 10.Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. asthma, wheezing, shortness of breath). 11.Any fever with temperature Greater than or equal to 38.0°C (100.4oF) in last 3 days prior to the study vaccination 12.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms. 13.Any known history or suspicion of thrombocytopenia or a bleeding disorder. 14.History of alcoholism or drug abuse. 15.Any history of receipt of blood products or immunoglobulins in last 3 months. 16.Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days. 17.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1.Solicited/unsolicited local adverse events after a single dose vaccination and during the 28 days follow-up period. 2.Solicited/unsolicited systemic adverse events after a single dose vaccination and during the 28 days follow-up period. 3.Occurrence of serious adverse events during the study period.Timepoint: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. Serious adverse events for entre study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Seroconversion rates for anti-Vi IgG and anti-Vi IgA antibody titres against S. Typhi on Days 28, 90 and 180 after vaccination. 2.Seroconversion rates for anti-OPS and SBA antibody titres against S. Paratyphi A on Days 28, 90 and 180 after vaccination. 3. GMTs of anti-Vi IgG and anti-Vi IgA antibodies against S. Typhi at pre-vaccination, and on Days 28, 90 and 180 post vaccination. 4.GMTs of SBA for paratyphoid A antigen against S. Paratyphi A at pre-vaccination and on Days 28, 90 and 180 post vaccination. 5.GMTs of anti-O-polysaccharide IgG antibodies measured by ELISA against S. Paratyphi A at pre-vaccination and on Days 28, 90 and 180 post vaccination. Exploratory 1. Seroconversion rates for anti-Vi IgG and anti-Vi IgA antibody titres against S. Typhi on Day 28 after vaccination in subjects with pre-existing seroprotective anti-tetanus antibody titres. 2.Seroconversion rates for anti-OPS and SBA antibody titres against S.Timepoint: 1. Seroconversion rates for anti-Vi IgG and anti-Vi IgA anti body titers against S. Typhi on Days 28, 90 and 180 after vaccination. 2. Seroconversion rates for anti-OPS and SBA antibody titres against S. Paratyphi A on Days 28, 90 and 180 after vaccination. 3.GMT of anti-Vi IgG and anti-Vi IgA anti bodies against S. Typhi at pre-vaccination and on Days 28, 90 and 180 after vaccination. 4. GMT of anti-OPS and SBA antibodies against S. Paratyphi A at pre-vaccination and on Days 28, 90 and 180 after vaccination. | — |
Countries
India
Contacts
Public ContactDr Sai Krishna
Human Biologicals Institute
Outcome results
None listed