A clinical study to assess safety and tolerability of tetanus, diptheria, and pertussis vaccine in adults.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2017/03/008003
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
1. Healthy adult male or female aged between 18-45 years and normal
Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg
weight.
2. Healthy subjects as established by personal medical history, physical
examination, laboratory investigation during screening and as per the
clinical judgment of the Investigator.
3. Sexually active participants to be using an effective method of
contraception (i.e. intrauterine device or hormonal contraception or
condom, diaphragm, cervical cap).
4. Subjectâ??s willingness and ability to comply with the requirements of
the protocol.
5. Subject willing to sign a written informed consent.
1. History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except
Tetanus-prone wound management for adults) in the past 5 years.
2. History of Tetanus, diphtheria or pertussis infection.
3. Female participant who is pregnant or breast-feeding, or wanting to fall pregnant during study.
4. History of any major illness.
5. History of major congenital defects or illness.
6. Investigator, site personnel directly affiliated with this study and their immediate families.
7. Acute illness and/or fever at the time of vaccination or during the past 7 days.
8. Chronic administration high doses of
corticosteroids, cytotoxic agents or radiotherapy or immune-modifying drugs in last 3 months.
9. Receipt of any oral or injectable antibiotics and/or antiviral from 5 days before screening through to enrollment.
10. History of receipt a blood transfusion or other blood products in the past one year.
11. Use of any investigational or non-registered drug.
12. History of administration of any vaccine within past 30 days or during the study
13. History of any major illness.
14. Participant having any allergies to medication and food.
15. History of anaphylactic shock
16. History or presence of significant alcoholism or drug abuse in the past one year.
18. History or presence of significant smoking.
19. Reactive serology for HIV, hepatitis B and hepatitis C viruses
20. Abnormal ECG and chest X-ray
21. Participation in a drug research study within past 3 months or planned participation during the study.
22. Participant has any plans to relocate from the area prior to the completion of the study.
23. Any other condition which in the opinion of the investigator will
jeopardize the safety of the subject due to participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Occurrence of immediate adverse events after single dose. <br/ ><br>2. Occurrence of solicited adverse reactions within 7-day post-vaccination <br/ ><br>follow-up period. <br/ ><br>3. Occurrence of solicited adverse events, including serious adverse <br/ ><br>events within 30 days after vaccination.Timepoint: 1. Blood and Urine samples for safety assessment to be drawn at screening, day 7 and day 30.
- Secondary Outcome Measures
Name Time Method Occurrence of unsolicited adverse events, including serious adverse <br/ ><br>events within 30 days after vaccination.Timepoint: Blood and Urine samples for safety assessment to be drawn at screening, day 7 and day 30.