Pertussis acellular pertussis vaccine (aP) and Tetanus Toxoid,
Conditions
Interventions
acellular Pertussis vaccine given intramuscularly as a single dose on Day 0,Adacel Tetanus-
acellular pertussis vaccine given intramuscularly as a single dose on Day 0
aP vaccine,TdaP vaccine,Adacel
Sponsors
BioNet-Asia Co., Ltd. 19 Soi Udomsuk 37, Sukhumvit 103 Road, Prakanong, Bangkok 10260, Thailand
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Age 12 to 17 years of age (less than 18 years full of age) 2. Subject written assent and parents or legal guardians written consent for 12 to 17 years old subjects 3. Healthy subjects as established by medical history and physical and medical examination 4. Capable to comply with the study protocol 5. For female subjects who had menarche, negative pregnancy test at enrollment and willing to take reliable birth control measures for 2 months after vaccination
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria at study entry will not be eligible for participation: 1. History of significant medical illness such as immune deficiency, uncontrolled diabetes or hypertension heart or renal or hepatic diseases 2. Pregnant or breast-feeding women 3. History of allergy to any vaccine component 4. History of serious adverse event or neurological adverse event after injection with any vaccine 5. Having received any other vaccines within 28 days prior to recruitment (3 months for live attenuated vaccines) 6. Plan to receive any other vaccines or plan to participate in another clinical trial during the study period (one year) 7. History of receiving blood or blood component or immunoglobulin within 3 months prior to recruitment 8. 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 recruitment 9. Having received diphtheria or tetanus or pertussis vaccine within 1 year prior to recruitment 10. Presence of acute febrile illness on the day of vaccination (This is a temporary exclusion criterion) 11. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome 12. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study 13. History of alcoholism and/or intravenous drug abuse 14. Presence of bleeding disorders, and abnormalities of splenic and thymic functions 15. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity endpoints 28 days after vaccination Seroconversion rates and GMTs for ELISA IgG antibodies against PT, FHA, DT, and TT and for PT Nab | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints 7 days for local & systemic reactions, 28 days for AEs and 1 year (entire study period) for SAE Local & systemic reactions, AEs and SAEs,Immunogenicity endpoints 28 days and 1 year after vaccination Seroconversion rates and GMTs for ELISA IgG antibodies against PT, FHA, DT, and TT and for PT Nab | — |
Countries
Thailand
Contacts
Public ContactSimonetta Viviani
BioNet-Asia Co., Ltd.
Outcome results
None listed