Pertussis vaccine Pertussis vaccine
Conditions
Interventions
Acellular pertussis (ap) vaccine given intramuscularly as a single dose (0.5 ml) on day 0,Tetanus toxoid,
diphtheria toxoid and medium dose of recombinant acellular pertussis vaccine given intramuscularly as a single dose (0.5 ml) on day 0,Acellular pertussis (aP) vaccine given intramuscularly as a single
diphtheria toxoid and recombinant acellular pertussis (TdaP) vaccine given intramuscularly as a single dose (0.5 ml) on day 0,Tetanus toxoid,
diphtheria toxoid and acellular pertussis vaccine,
Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
BioNet ap,BioNet Tdap,Licensed aP,Licensed TdaP,Licensed Tdap
Sponsors
Chulalongkorn University
BioNet-
Asia Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentages of participants with post-immunization local and systemic reactions During 7 days following vaccination Self assessment by participant and data record from Diary Card ,Percentages of participants with AEs During 28 days following vaccination AEs reported by participant,Percentages of participants with SAEs From the day of vaccination until Day 28 following vaccination SAEs reported by participant | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion rate of anti-PT and anti-FHA antibodies and PT-neutralizing antibody titers. 28 days after vaccination Proportion achieving response: 4-fold rise (baseline between 5 and 20 IU/mL), 2-fold (baseline from 20 IU/mL) or reaching 20 IU/mL(baseline below 5); anti-PT/FHA by ELISA and PTNA by CHO assay,Seroconversion rate of anti-PT and anti-FHA antibodies and PT-neutralizing antibody titers. 1 year after vaccination Proportion of participants; greater than or equal to 20 IU/mL of anti-PT and anti-FHA antibodies measured by ELISA and PT-neutralizing antibody titers measured by CHO cell assay. ,Seroprotection rate of anti-tetanus and anti-diphtheria antibodies. 28 days and 1 year after vaccination. Proportion of participants with greater than or equal to 0.1 IU/mL of anti-tetanus and anti-diphtheria antibodies measured by ELISA.,Geometric mean concentration (GMC) of anti-PT, anti-FHA, anti-tetanus and anti-diphtheria antibodies and geometric mean titer (GMT) of PT-neutralizing antibody. Baseline (before vaccination), 28 days after vaccination and 1 year after vaccination. Anti-PT, anti-FHA, anti-tetanus and anti-diphtheria antibody concentrations measured by ELISA and PT-neutralizing antibody titers measured by CHO cell assay,Percentage of participant with SAEs. From the day of vaccination until 1 year after vaccination. SAEs reported by participants. | — |
Countries
Thailand
Contacts
Public ContactSouad Mansouri
BioNet-Asia Co., Ltd.
Outcome results
None listed