A Clinical Trial to Assess the safety and immunogenicity of a combined Tetanus, Diphtheria, Acellular Pertussis and Poliomyelitis Vaccine (SIIPL Tdap-IPV) compared with Boostrix-IPV in Healthy Adults, Adolescents and Childre
- Conditions
- TetanusDiphtheriaPertussisPolioInfection - Other infectious diseases
- Registration Number
- ACTRN12620000848909
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 107
Phase 1:
1. Healthy male and female adults aged between 18 years and 65 years on the day of vaccination, who have received primary immunization series of the DTP vaccine.
2. Subjects willingness and ability to comply with the requirements of the protocol.
3. Women of childbearing potential (any female who has experienced menarche and who has not undergone surgical sterilization [including hysterectomy or bilateral oophorectomy]
or who is not postmenopausal) and their partners must agree to use a highly effective method of contraception for the duration of the study (from signing of the informed consent form), and for 30 days after the last dose of study drug, unless the subject has
undergone surgical sterilization or her partner has undergone vasectomy (both >6 months prior to study), or is a postmenopausal female (no menstrual period for 2 years prior
to study).
Males must agree to use a condom with the partner using a highly effective method of contraception.
Phase 2:
1. Healthy male and female adults, adolescents and children aged between 4 years and 65 years on the day of vaccination, who have received primary immunization series of the DTP vaccine.
2. Subjects/legal guardian’s willingness and ability to comply with the requirements of the protocol.
3. Women of childbearing potential (any female who has experienced menarche and who has not undergone surgical sterilization [including hysterectomy or bilateral oophorectomy]
or who is not postmenopausal) and their partners must agree to use a highly effective method of contraception for the duration of the study (from signing of the informed consent form), and for 30 days after the last dose of study drug, unless the subject has
undergone surgical sterilization or her partner has undergone vasectomy (both >6 months prior to study), or is a postmenopausal female (no menstrual period for 2 years prior
to study).
Males must agree to use a condom with the partner using a highly effective method of contraception.
1. Children: History of previous vaccination against diphtheria, tetanus and pertussis with either the study vaccine or another vaccine in the past 2 years.
2. Adolescents and adults: History of previous vaccination against diphtheria, tetanus, pertussis or poliomyelitis (excluding tetanus- or Td-prone wound management for adults and/or for tetanus or Td vaccination in pregnant women) in the past 4 years.
3. History of tetanus, diphtheria, pertussis or poliomyelitis infection (confirmed either
clinically, serologically or microbiologically).
4. Administration of any investigational drug, or any vaccine within 30 days prior to vaccination.
5. History of a severe allergic reaction or hypersensitivity after a previous dose of any DT-, TT-, pertussis antigen or inactivated poliovirus types 1, 2 and 3 containing vaccine or to any component of the study vaccines.
7. History of adverse event known to have occurred in temporal relation to receipt of pertussis-containing vaccine.
8. History of Guillain-Barré syndrome or brachial neuritis that occurred within 6 weeks of receipt of a prior tetanus vaccine.
9. History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause.
10. History of transient thrombocytopenia or a bleeding disorder following an intramuscular administration.
11. History of neurological complications following an earlier vaccination against diphtheria and/or tetanus.
12. History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastrointestinal, hepato-biliary, hematological functional abnormality, or mental disability.
13. History of surgery done within 30 days prior to the vaccination.
14. History of progressive or unstable neurologic conditions (e.g. cerebrovascular events).
15. Acute illness (moderate or severe) and/or fever (axillary temperature =38°C) at the time of vaccination or during the 72 hours prior to the vaccination.
16. History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination, or planned administration during the active study period
17. Subjects with altered immunocompetence such as subjects with ongoing cancer treatment, human immunodeficiency virus (HIV) infection or any other active immune system disorder.
18. Subjects who have undergone organ transplant surgery.
19. Chronic administration of immunosuppressant or other immune modifying drugs during the period starting 6 months prior to the study vaccine dose, excluding inhaled or topical steroids.
20. Females who are pregnant or breastfeeding.
21. Subject has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
22. Concurrent participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure in the preceding 30 days from enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method