To Evaluate the efficacy and Safety of a test vaccine (Tetanus, diphtheria, pertussis) in comparison to a marketed vaccine in healthy Subjects Aged 4-65 years.
- Registration Number
- CTRI/2024/06/068559
- Lead Sponsor
- Techinvention Lifecare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method