None listed
Conditions
Interventions
Intervention1: BoostagenREDTM: (combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine) by BioNet-Asia Co. Ltd. Thaialand.
A single dose (0.5 mL) of the vaccine wi
Sponsors
Techinvention Lifecare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects aged 4-65 years at the time of enrolment. 2. Subjects with good health as determined by personal medical history and physical examination during screening as determined by the investigator. 3. Subjects who require booster vaccination against diphtheria, tetanus, and pertussis and have previously received at least 4 doses of DPT within the first 2 years of life (inclusive of 3 primary vaccinations and 1 booster dose of DPT) 4. Subject and/or his/her parent/LAR who are willing to give written informed consent/assent before any study procedure 5. Female subjects (subjects of childbearing potential and married or sexually active) must have a negative urine pregnancy test at enrollment and be willing to take reliable birth control measures for 1 month after vaccination 6. Able to attend all scheduled visits and to understand and comply with the study procedures in the investigator’s judgment
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of previous vaccination against diphtheria, tetanus, and pertussis with either study vaccine or another licensed vaccine in the past 12 months in subjects aged 4-7 years of age 2. Subjects with a history of previous vaccination against diphtheria, tetanus, and pertussis with either study vaccine or another vaccine (except tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 years in subjects aged = 8 years 3. Subjects who have a history of a previous disease potentially related to any of the agents targeted by the DPT vaccine 4. Subjects with known hypersensitivity to any component of the study vaccine (including excipients) or a history of life threatening local or systemic reactions after previous administration of the vaccine or a vaccine containing the same substances 5. Subject with acute severe febrile illness on the day of the vaccination and/ or with evidence of acute illness within the past 7 days requiring systemic antibiotic or antiviral therapy. 6. Pregnant or lactating women should be excluded by performing urine pregnancy test during screening 7. Subjects with any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination 8. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization 9. If the subject has experienced any of the following events in temporal relationship to previous vaccination with pertussis-containing vaccine: a. Temperature of greater than or equals to 40.0 degree Celsius within 48 hours of vaccination, not due to another identifiable cause b. Collapse or shock-like state (hypotonic – hypo - responsiveness episode) within 48 hours of vaccination c. Convulsions with or without fever, occurring within 3 days of vaccination d. Encephalopathy of unknown origin occurring within 7 days of vaccination 10. Subjects with any chronic or active neurologic disorder, including seizures and epilepsy 11. Presence of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/narrowing of airways), gastrointestinal, endocrine, dermatological, neurological, or psychiatric disease or disorder, cancer, or autoimmune disease under treatment that in the opinion of the investigator, are likely to interfere with study outcome or study subject safety 12. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants, or other immune-modifying drugs in the past or any time during the study or intake of any other medications which may interfere with study volunteers’ self-assessing ability/safety 13. Known history of administration of blood or blood-derived products in the past 3 months 14. Significant alcoholism or drug abuse which may interfere with study volunteers’ self- assessing ability/safety 15. Subjects with a known history of Guillain-Barré syndrome 16. Subjects who have received any other vaccines within 28 days before recruitment (3 months for live attenuated vaccines) 17. Planned participation in another clinical study during the study period 18. Subjects p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentages of subjects achieving a significant booster response in anti-PT IgG and anti-FHA IgG antibody concentrations at Day 29 after vaccination in BoostagenREDTM and ADACEL® vaccine groups.Timepoint: at Day 29 after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 GMCs of anti-PT IgG & anti-FHA IgG antibody concentrations as measured by ELISA. 2 Percentage of subjects with seroprotection against DT as defined by anti-DT IgG antibody concentrations = 0.1 IU/mL measured by ELISA 3 Percentage of subjects with seroprotection against TT as defined by anti-TT IgG antibody concentrations = 0.1 IU/mL measured by ELISA 4 GMCs of anti-DT IgG & anti-TT IgG antibody concentrations as measured by ELISA 5 GMTs of PT-neutralizing antibodies as assessed by PT neutralization assay in CHO cells 6 Percentage of subjects achieving a booster response against PT as assessed by PT neutralization assay in CHO cells Safety endpoints 7 Percentage of subjects with solicited local & systemic ADRs reported within 7 days after vaccination 8 Percentage of subjects with unsolicited AEs & SAEs from study vaccine administration until Day 29Timepoint: at pre vaccination & Day 29 after vaccination. | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Clinical Research Network India Pvt. Ltd.
Outcome results
None listed