Pertussis Pertussis
Conditions
Interventions
Acellular pertussis (DTaP) vaccine given intramuscularly as a single dose (0.5 ml) on day 0,Acellular pertussis (DTaP) vaccine given intramuscularly as a single dose (0.5 ml) on day 0
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
Combined Diphtheria-
Tetanus-
recombinant acellular pertussis (DTaP) vaccine,Licensed DTaP
Sponsors
Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol Uiversity
BioNet-
Asia Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
15 Months to 36 Months
Inclusion criteria
Inclusion criteria: Participants will be eligible for inclusion if ALL of the following criteria are met at the time of screening: 1. 15 to 36 months of age at the time of vaccination 2. Having completed the 3-dose DTwP or 3-dose DTaP vaccination (no interchange of DTwP and DTaP during primary immunization) 3. The parents or legal guardians of the participant are able to read and write. 4. The parents or legal guardians can provide written informed consent 5. Healthy, as established by pertinent medical history and physical examination.
Exclusion criteria
Exclusion criteria: A participant with ANY of the following criteria at study entry will not be eligible for participation: 1. History of any significant medical illness such as, but not limited to, immune deficiency, renal, hepatic, cardiovascular, or endocrine disorder as determined by the investigator based on medical history and physical examination. 2. History of allergy or hypersensitivity to any vaccine (including its component). 3. History of any serious adverse event or neurological adverse event after vaccination. 4. Having received only 1 or 2 doses of DTwP or DTaP (incomplete primary immunization) after birth until the study enrollment. 5. Having received the 4th dose DTwP or DTaP vaccination. 6. Having experienced a physician diagnosed diphtheria or tetanus or pertussis illness within 1 year prior to recruitment. 7. Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines). 8. Planning to receive tetanus, diphtheria, pertussis or planning to participate in another clinical trial during the study period (approximately 1 year). 9. Receipt of blood or blood component or immunoglobulin within 3 months prior to recruitment. 10. History of receiving any immunosuppressive drug or systemic corticosteroid (more than 0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment. 11. Any bleeding disorder. 12. Any abnormality of splenic or thymic function. 13. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barre syndrome; 14. History of any illness including cognitive impairment and psychiatric disease that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants due to participation in the study. 15. Fever as defined by body temperature more than 38 degree celsius at the time of enrollment (temporary exclusion criterion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rates of PT At 28 days following vaccination ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentages of participants with solicited 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 During 28 days following vaccination SAEs reported by participant,GMT antibody concentration to anti-PT neutralizing antibody Baseline and Day 28 after vaccination CHO,GMT antibody concentration to DT, TT, PT and FHA Baseline and Day 28 after vaccination ELISA,Seroprotection rates of Tetanus and Diphtheria Day 28 after vaccination ELISA,Seroconversion rates of FHA and anti-PT neutralizing antibody Day 28 after vaccination ELISA and CHO,Percentages of participants with SAEs Day 336 after vaccination SAEs reported by participant,Seroconversion rates of FHA and anti-PT neutralizing antibody Day 336 after vaccination ELISA and CHO,GMT antibody concentration to DT, TT, PT and FHA Day 336 after vaccination CHO ,Seroprotection rates of Tetanus and Diphtheria Day 336 after vaccination ELISA | — |
Countries
Thailand
Contacts
Public ContactSouad Mansouri
Bionet-Asia Co., Ltd.
Outcome results
None listed