Pertussis Whooping cough acellular Pertussis TdaP
Conditions
Interventions
acellular Pertussis vaccine given intramuscullarly as a single dose on Day 0,Licensed Tetanus-
acellular Pertussis vaccine given intramuscullarly as a single dose on Day 0
aP vaccine,TdaP vaccine,Licensed TdaP comparator
Sponsors
BioNet-Asia Co., Ltd. 19 Soi Udomsuk 37, Sukhumvit 103 Rd., Prakanong, Bangkok 10260 Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1 Age 18 to 35 years of age 2 Written informed consent 3 Free of obvious health problems as established by medical history and screening evaluations including physical examination and laboratory test 4 Capable to comply with the study protocol 5 For women willing to take reliable birth control measures 2 months after participating into the study
Exclusion criteria
Exclusion criteria: 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 DTP vaccine 5 Having received another vaccination within 28 days prior to recruitment or 3 months for live attenuated vaccines 6 Plan to receive other vaccine during the study period 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 per 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 5 years prior to recruitment 10 Presence of acute febrile illness on the day of vaccination This is temporary exclusion criterion 11 Individuals with any progressive or severe neurological disorder or seizure disorder or Guillain Barre 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 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 15 For subjects screened at Day -14 to Day -1: presence of any clinically or laboratory significant abnormality on physical examination or laboratory tests upon investigator judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints During 28 days following the vaccination Laboratory tests, local and systemic reactions, AEs/SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity endpoints At 7 and 28 days after vaccination Seroconversion rates and antibody titers for pertussis, diphtheria and tetanus | — |
Countries
Thailand
Contacts
Public ContactSimonetta Viviani
BioNet-Asia Co., Ltd.
Outcome results
None listed