A clinical study to assess the safety of Diptheria, Tetanus, acellular Pertussis, Poliomyelitis and Haemophilus influenzae type b vaccine in healthy adults
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2017/07/009034
- 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
- 24
1. Healthy adult human subjects between 18 and 45 years of age (both
inclusive) .
2. Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive),
calculated as weight in kg/height in m2 with minimum of 50 kg weight.
3. Healthy subjects as established by personal medical history, physical
examination, laboratory investigation during screening and as per the
clinical judgment of the Investigator.
4. Sexually active participants to be using an effective method of
contraception (i.e. intrauterine device or hormonal contraception or
condom, diaphragm, cervical cap).
5. Subjectâ??s willingness and ability to comply with the requirements of the
protocol.
6. Subject willing to sign a written informed consent.
1. History of any allergic diseases or history of a serious reaction to any prior
vaccination or known hypersensitivity to any component of the study
vaccines.
2. History of anaphylactic shock.
3. History of previous vaccination against diphtheria, tetanus, pertussis, polio
or Hib with either the trial vaccine or another vaccine (except Tetanusprone
wound management for adults) in the past 5 years.
4. History of diphtheria, tetanus, pertussis, polio or Haemophilus influenzae
type B infection (confirmed either clinically, serologically or
microbiologically).
5. History of major congenital defects or illness that require medical therapy,
as determined by medical history or clinical assessment.
6. History of any cancer, leukemia, HIV infection, organ transplant or any
other immune system disease.
7. History or presence of any disease or condition which might compromise
the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous,
cardiovascular, immunological, dermatological, gastrointestinal or any
other body system.
8. Ingestion or Use of any medication (including herbal remedies) at any
time in 14 days or immune-modifying drugs in last 3 months prior to IP
administration or planned at any time during the study. In any such case
subject selection will be at the discretion of the Principal Investigator.
9. Any history or presence of asthma (including aspirin induced asthma) or
nasal polyp or NSAIDs induced urticaria.
10. Smokers, who smoke 10 or more than 10 cigarettes/beedis per day or
inability to abstain from smoking during the study.
11. History of significant alcoholism in the past one year.
12. The presence of clinically significant abnormal laboratory values during
screening.
13. Abnormal ECG and chest X-ray.
14. Use of any recreational drugs or history of drug addiction or testing
positive in pre study drug scans.
15. History or presence of psychiatric disorder
16. A positive hepatitis screen including hepatitis B surface antigen and/or
HCV antibodies.
17. A positive test result for HIV antibody.
18. Female participant who is pregnant or breast-feeding, or wanting to fall
pregnant during trial participation.
19. Investigator, site personnel directly affiliated with this study and their
immediate families. Immediate family is defined as a spouse, parent, child
or sibling, whether biological or legally adopted.
20. Acute illness (moderate or severe) and/or fever (oral temperature >=38°C)
at the time of vaccination or during the 7 days prior to the vaccination.
21. History of receipt a blood transfusion or other blood products in the year
prior to screening.
22. Use of any investigational or non-registered drug within 30 days preceding
the study vaccine administration, or planned use during the study period.
23. History of administration of any vaccine within 30 days prior to
administration of study vaccine or planned during the course of study
participation.
24. Participation in a drug research study within past 3 months or planned
participation during the study.
25. Participant has any plans to permanently relocate from the area prior to the
completion of
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method