Pertussis Pertussis
Conditions
Interventions
BioNet ap,BioNet Tdap (low dose),BioNet Tdap (medium dose),Boostagen,Boostrix
Sponsors
BioNet-Asia Co.,Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-40 years (inclusive) at the time of enrollment; 2. Willing and able to provide written informed consent prior to any study procedure; 3. Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening; 4. Must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for 1 month after vaccination; 5. Able to attend all scheduled visits and to understand and comply with the study procedures in the principal investigator's judgment.
Exclusion criteria
Exclusion criteria: 1. Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam; 2. Pregnant or breast-feeding women or female who intends to become pregnant during the study period; 3. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions; 4. Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients); 5. Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial; 6. Receipt of licensed vaccines within 30 days prior to enrollment (3 months for live attenuated vaccines) or plan to receive other vaccine during the study period; 7. Receipt of diphtheria or tetanus or pertussis vaccine within 1 year prior to enrollment; 8. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination; 9. Any chronic or active neurologic disorder, including seizures, and epilepsy; 10. Has a known history of Guillain-Barre Syndrome; 11. Has an active malignancy or recent (<10 years) history of metastatic or hematologic malignancy; 12. Suspected or known alcohol and/or illicit drug abuse within the past 5 years; 13. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period; 14. 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; 15. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity endpoint 28 days after vaccination Seroresponse rate of anti-PT ELISA IgG antibody | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity endpoints at 28 days after vaccination Seroresponse rate of anti-FHA ELISA IgG antibody, Seroprotection rate of anti-tetanus and anti-dipht,Safety endpoints at 7 days after vaccination for solicited AEs and 28 days after vaccination for Unsolicited AE,SAE solicited local and systemic adverse events (AEs)/ Unsolicited AEs/ serious adverse events (SAEs) | — |
Countries
Thailand
Contacts
Public ContactSouad Mansouri
Bionet-Asia Co., Ltd.
Outcome results
None listed