Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BE Td Vaccine: 0.5mL administered intramuscularly as a single booster dose on 0 day.
Control Intervention1: Sii Td-Vac Vaccine: 0.5mL administered intramuscularly as a single booster do
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Written informed consent from the subject or subjectâ??s parent/guardian or subjectâ??s legally acceptable representative 2.Informed assent directly from the child/adolescent aged between >=7 to 3.Healthy Indian subjects of either gender between >=7 to =18 years of age in adult age subset at the time of vaccination. 4.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >103.5°F [ >39.5°C]). 5.History of previous primary immunisation with DTP vaccine at childhood. 6.Willingness of subject or subjectâ??s parent/guardian or their legally acceptable representative not to participate in any other clinical trial during the course of study. 7.Subject or subjectâ??s parent/guardian or subjectâ??s legally acceptable representative willing to comply with the protocol requirements. 8.Subjects who were not receiving any immunosuppressive therapy. 9.Subjects without contraindications or precautionary circumstances.
Exclusion criteria
Exclusion criteria: 1.History of Tetanus (TT) or Tetanus with reduced diphtheria (Td) booster vaccination within last 5 years. 2.Subjects with acute disease at the time of enrolment, defined as â??presence of a moderate or severe illnessâ??. 3.Life-threatening or serious cardiac, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematologic or immunologic disorder. 4.Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. 5.Pregnant women and women with childbearing potential not following proven contraceptive methods. 6.Subjects on immunosuppressive or immunostimulant therapy. 7.Any confirmed or suspected immunosuppressive or immunodeficient condition. 8.Known case of hypersensitivity to any of the components of Td vaccine. 9. Known history of any serious adverse reaction/event (SAR/SAE) with previous Tetanus and Diphtheria immunizations. 10.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number and percentage of subjects achieving seroprotection levels of anti-Tetanus and anti-Diphtheria antibodies. 2.Two sided 95% confidence intervals for the difference in proportions of subjects achieving seroprotection rates of anti-Tetanus and anti-Diphtheria antibody titresTimepoint: 1.At day 30 in both the treatment arms across target age subsets 2.At day 30 post single booster dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Geometric Mean Titres (GMT) 2.Two fold and four fold rise in anti-Tetanus and anti-Diphtheria antibody titres. 3.Occurrence of solicited local adverse events 4.Occurrence of both solicited and unsolicited local and systemic adverse events (AEs) 5.Occurrence of serious adverse events (SAEs)Timepoint: 1.At day 30 estimated in both treatment arms across targeted age subsets and compared 2. 30 days after the booster dose 3.Within 30 minutes post vaccination 4.a. During 7-day (Day 0-6) follow up period after single booster dose 4.b.During the subsequent follow up period from Day 7 to day 30 5.Over the entire course of the study | — |
Countries
India
Contacts
Public ContactMr Shekhar Gupta
Biological E. Limited
Outcome results
None listed