Safety and Antibody Responses in Adults and Elderly after Immunization with a Recombinant Pertussis Booster Dose

Phase 3

Completed

• Conditions: Pertussis vaccine

• Registration Number: TCTR20190927006
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-27
• Study Completion: 2021-08-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 734

Inclusion Criteria

1. Aged 18 to 64 years (less than 65 years full of age) or 65 to 75 years (less than 76 years full of age) on the day of inclusion;
2. Can provide written informed consent;
3. Healthy, as established by pertinent medical history and physical examination;
4. Capable of complying with the study protocol and procedures;
5. For women who have not had menopause, must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for two months after vaccination.

Exclusion Criteria

1. History of significant medical illness such as but not limited to immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participations safety and the evaluation of investigational vaccines in this study;
2. Breastfeeding women or female participants who intend to become pregnant during the study period;
3. History of a severe allergic reaction to any vaccine (including its components);
4. History of serious adverse event or neurological adverse event to any vaccination;
5. Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines);
6. Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period (approximately one year);
7. Having been experienced physician-diagnosed pertussis within 1 year prior to enrollment;
8. Receipt of diphtheria or tetanus or pertussis vaccine within 1 year prior to enrollment;
9. Any chronic or active neurologic disorder, including seizure, and epilepsy;
10. Has a known history of Guillain-Barr Syndrome;
11. Has an active malignancy or recent (<10 years) history of metastatic or hematologic malignancy;
12. Any bleeding disorder indicated;
13. Suspected or known alcoholism and/or illicit drug abuse within the past 5 years;
14. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
15. History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to study entry;
16. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual having an adverse outcome by participating in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified