Pertussis vaccine Pertussis vaccine
Conditions
Interventions
Participants who received BioNet aP vaccine in the initial TDA206 study,Participants who received BioNet TdaP vaccine in the initial TDA206 study,Participants who received License aP vaccine in the in
Prevention,Prevention,Prevention,Prevention,Prevention
BioNet aP vaccine group,BioNet TdaP vaccine group,License aP vaccine group,License TdaP vaccine group,License Tdap group
Sponsors
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: At 2-year Follow-up Visit A participant will be eligible for inclusion if ALL of the followings apply at the time of screening: 1. Having participated in the initial TDA206 study and received a single dose of one of the 5 study vaccines. This participant should have also been a part of the randomly pre-selected participants who were subject to immunogenicity assay at Visit 4 and completed the study; 2. Written informed consent for 2-year follow-up visit is obtained prior to study entry; 3. Capable of complying with study procedures and willing to provide with a blood sample. At 3-year Follow-up Visit A participant will be eligible for inclusion if ALL of the followings apply at the time of screening: 1. Having participated in the initial TDA206 study and received a single dose of one of the 5 study vaccines. This participant should have also been a part of the randomly pre-selected participants who were subject to immunogenicity assay at Visit 4 and completed the study; 2. Written informed consent for 3-year follow-up visit is obtained prior to study entry; 3. Capable of complying with study procedures and willing to provide with a blood sample.
Exclusion criteria
Exclusion criteria: At 2-year Follow-up Visit A participant with following criteria at screening will not be eligible for participation: 1. Having received pertussis vaccine since the completion of Visit 4 in TDA206 study 2. Anything in the opinion of the investigator that would prevent the healthy volunteer from participating in the study or would put the participant at risk At 3-year Follow-up Visit A participant with following criteria at screening will not be eligible for participation: 1. Having received pertussis vaccine since the completion of Visit 4 in TDA206 study 2. Anything in the opinion of the investigator that would prevent the healthy volunteer from participating in the study or would put the participant at risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rates of anti-PT and anti-FHA antibodies in BioNet Recombinant ap, BioNet Recombinant Tdap and Licensed Tdap 2 and 3 years after vaccination ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion rates of anti-PT and anti-FHA antibodies in License aP and License TdaP vaccine groups 2 and 3 years after vaccination ELISA,Seroconversion rates of PT antibody in License aP and License TdaP vaccine groups 2 and 3 years after vaccination PT neutralizing in CHO cell assay,GMC of anti-PT, anti-FHA, anti-tetanus and anti-diphtheria antibodies in each study group 2 and 3 years after vaccination ELISA,Seroprotection rates of anti-tetanus and anti-diphtheria antibodies in BioNet Recombinant Tdap, Licensed TdaP and Licensed Tdap 2 and 3 years after vaccination ELISA ,GMTof PT antibody in each study group 2 and 3 years after vaccination PT neutralizing in CHO cell assay | — |
Countries
Thailand
Contacts
Public ContactSouad Mansouri
BioNet-Asia Co.,Ltd.
Outcome results
None listed