Immunogenicity of various recombinant acellular pertussis-containing vaccines in healthy adolescents
- Conditions
- Pertussis
- Registration Number
- TCTR20181031001
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Both BioNet vaccines induced higher pertussis antibody responses that persisted to be higher at 1 year than the comparator vaccine. All BioNet vaccines have shown a similar tolerability and safety profile to the comparator vaccine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 450
Subjects will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
1. 9 to 17 years of age (less than 18 years full of age);
2. Subjects can provide written informed assent and parents or legal guardians of the subjects can provide written informed consent;
3. Healthy, as established by pertinent medical history and physical examination;
4. Both subject and parent or legal guardian are capable of complying with the study protocol within the investigator's judgement;
5. Female subjects who started menarche must have a negative urine pregnancy test at enrollment and must be willing to commit to reliable birth control measures for two months after vaccination.
Exclusion Criteria
A subject with ANY of the following criteria at study entry will not be eligible for participation:
1. History of significant medical illness such as but not limited to immune deficiency, renal, hepatic, cardiovascular, endocrine disorder as determined by the Investigator based on medical history and physical examination;
2. Breastfeeding females;
3. History of allergy to any vaccine (including its component);
4. History of serious adverse event or neurological adverse event after vaccination;
5. Having received diphtheria or tetanus or having experienced a physician-diagnosed pertussis illness within 1 year prior to recruitment;
6. Receipt of pertussis vaccine later than the age of 7 years;
7. Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines);
8. Plan to receive tetanus, diphtheria or pertussis vaccines or plan to participate in another clinical trial during the study period (approximately one 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-Barr 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 subjects due to participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroconversion rates of antibodies to PT and FHA in Tdap groups at 28 days after vaccination ELISA
- Secondary Outcome Measures
Name Time Method Percentage of subjects with post-immunization local and systemic reactions 7 days after vaccination Reporting by subjects,Percentage of subjects with unsolicited AEs through 28 days following vaccination Reporting by subjects,Percentage of subjects with SAEs through 28 days following vaccination Reporting by subjects,Seroconversion rates of PT and FHA of ap group End of study ELISA,Seroconversion rates of tetanus and diphtheria antibodies in Tdap groups End of study ELISA,Geometric mean antibody concentrations to PT, FHA, tetanus and diphtheria End of study ELISA,Geometric mean antibody concentrations to PT and FHA End of study ELISA,Seroconversion rates of PT neutralizing antibodies End of study CHO cells,Geometric mean antibody concentrations to PT-neutralizing antibodies End of study CHO cells