Phase
Condition
Pertussis (Whooping Cough)
Treatment
Pertussis containing vaccine
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- An adult participant will be eligible for inclusion if ALL of the following criteriaare met at the time of screening:
Aged 18 to 75 years (less than 76 years full of age) on the day of inclusion;
Can provide written informed consent;
Healthy, as established by pertinent medical history and physical examination;
Capable of complying with the study protocol and procedures;
For women with childbearing potential (i.e., urine pregnancy test will not beperformed in females who have undergone sterilization, hysterectomy or who arepost-menopausal.), must have a negative urine pregnancy test at enrollment.
Exclusion
Exclusion Criteria:
- A participant with ANY of the following criteria at study entry will not be eligiblefor participation:
History of significant medical illness such as but not limited to immunedeficiency, clinically significant psychiatric, hematologic, pulmonary,cardiovascular, or hepatic, renal, splenic or thymic functional abnormality asdetermined by the investigator based on medical history and physicalexamination. For those cases that are clinically stable, the investigator mayinclude them as deemed per medical judgement.
Breastfeeding women or female participants who intend to become pregnant duringthe study period;
History of a severe allergic reaction to any vaccine (including itscomponents);
History of serious adverse event or neurological adverse event to anyvaccination;
Receipt of any investigational product or licensed vaccine within 30 days priorto enrollment (3 months for live-attenuated vaccines);
Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participatein other clinical trial during the study period;
Having experienced physician-diagnosed pertussis within 5 year prior toenrollment;
Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior toenrollment;
Having any progressive or severe neurologic disorder, seizure disorder orrecent history of Guillain-Barré syndrome;
Medically significant cancer (except for benign or localized skin cancer,cancer in remission for ≥10 years);
A known bleeding diathesis or any condition that may be associated with aprolonged bleeding time resulting in a problem with intramuscular injection;
Suspected or known alcoholism and/or illicit drug abuse within the past 5years;
Administration of immunoglobulins and/or any blood products within 3 monthspreceding study entry or planned administration during the study period;
History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5mg/kg of prednisolone or equivalent for more than 14 days) within 3 monthsprior to study entry;
Has any active clinically significant finding or life-threatening disease that,in the opinion of the investigator, would increase the risk of the individual'shaving an adverse outcome by participating in this study.
Study Design
Study Description
Connect with a study center
Chula Clinical Research Center (Chula CRC)
Thailand, Bangkok 10330
ThailandActive - Recruiting
Queen Saovabha Memorial Institute, Thai Red Cross Society
Thailand, Bangkok 10330
ThailandActive - Recruiting
Thai Red Cross AIDS and Infectious Diseases Research Centre
Thailand, Bangkok 10330
ThailandActive - Recruiting
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