Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Participants with Anti-Pertussis Toxoid (PT) and Anti-Filamentous Hemagglutinin (FHA) Antibody (Ab) Concentrations >= Lower Limit of Quantification (LLOQ) and >=4*LLOQ at Baseline |
Anti-PT and anti-FHA Ab concentrations are determined in terms of endotoxin units per millilitre (EU/mL). |
Day 0 (baseline) |
|
Primary |
Geometric Means of Anti-Pertussis Toxoid and Anti-Filamentous Hemagglutinin Antibody Concentrations at Baseline |
Anti-PT and anti-FHA Ab levels are measured by electrochemiluminescence immunoassay (ECL) and anti-PT and anti-FHA Ab concentrations are determined in terms of EU/mL. |
Day 0 (baseline) |
|
Primary |
Geometric Means of Antibody Titers/Concentrations After Primary Series Vaccination |
Anti-diphtheria, anti-tetanus, anti-PT and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-polyribosylribitol phosphate (PRP) Ab levels are measured using a Farr-type radioimmunoassay (RIA). Ab concentrations are determined as: anti-diphtheria >=0.01 international units (IU)/mL, >=0.1 IU/mL, 1.0 IU/mL, anti-tetanus >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP >=0.15 microgram (mcg)/mL, >=1.0 mcg/mL, anti-Poliovirus types 1, 2, and 3 Ab titers >=8 (1/dilution [dil]), Anti-Hep B >=10 milli (m) IU/mL, and >=100 mIU/mL. |
Day 90 (1 month after third dose) |
|
Primary |
Number of Participants With Seroprotection After Primary Series Vaccination |
Seroprotection is determined as: anti-diptheria Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-tetanus Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (>=LLOQ and >=4*LLOQ), anti-PRP Ab concentrations >=0.15 mcg/mL and >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), anti-Hep B Ab concentrations >=10 mIU/mL and >=100 mIU/mL. |
Day 90 (1 month after third dose) |
|
Primary |
Number of Participants with Vaccine Response or Seroconversion After Primary Series Vaccination |
Vaccine response is defined for anti-PT and anti-FHA as Ab post-Dose 3 concentrations >=4*LLOQ, if pre-Dose (Day 0) Ab concentration is <4*LLOQ or 1 month after third dose (Day 90) concentrations >= pre-Dose Ab concentrations if pre-Dose (Day 0) concentrations >=4*LLOQ. Seroconversion for anti-PT and anti-FHA is defined as >=4-fold Ab concentrations increase from pre-Dose (Day 0) to 1 month after third dose (Day 90). |
Day 0 (baseline), Day 90 (1 month after third dose) |
|
Primary |
Geometric Means of Antibody Titers/Concentrations After Booster Vaccination |
Anti-diphtheria, anti-tetanus, anti-PT, and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels are measured using a Farr-type RIA. Ab concentrations: anti-diphtheria >=0.01 IU/mL, >=0.1 IU/mL, >=1.0 IU/mL, anti-tetanus >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP >=0.15 mcg/mL, >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), anti-Hep B >=10 mIU/mL, and >=100 mIU/mL. |
Day 420 (1 month after booster vaccination) |
|
Primary |
Number of Participants With Seroprotection After Booster Vaccination |
Seroprotection: anti-diphtheria Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-tetanus Ab concentrations >=0.01 IU/mL, >=0.1 IU/mL, and >=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (>=LLOQ and >=4*LLOQ), anti-PRP Ab concentrations >=0.15 mcg/mL and >=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers >=8 (1/dil), and anti-Hep B Ab concentrations >=10 mIU/mL and >=100 mIU/mL. |
Day 420 (1 month after booster vaccination) |
|
Primary |
Number of Participants With Vaccine Response or Seroconversion After Booster Vaccination |
Vaccine response is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose (Day 420), if pre-Dose (Day 0) Ab concentrations <4*LLOQ; or >=2 fold Ab concentrations increase from pre- dose (Day 0) to 1 month after booster dose (Day 420), if pre-dose (Day 0) Ab concentrations >=4*LLOQ. Seroconversion is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose. |
Day 0 (baseline), Day 420 (1 month after booster vaccination) |
|
Primary |
Number of Participants With Booster Response After Booster Vaccination |
Booster response is defined for anti-PT and anti-FHA as >=4 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 420), if pre-booster Ab concentrations <4*LLOQ; or >=2 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 390) if pre-Booster Ab concentrations >=4*LLOQ. |
Day 390 (pre-booster), Day 420 (1 month after booster dose) |
|
Secondary |
Number of Participants With Immediate Unsolicited Adverse Events (AE) After Primary Series Vaccination |
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. |
Within 30 minutes after vaccination |
|
Secondary |
Number of Participants With Solicited Injections Site or Systemic Reactions After Primary Series Vaccination |
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: injection site tenderness, erythema, and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability |
Within 7 days after vaccination |
|
Secondary |
Number of Participants With Unsolicited Adverse Events After Primary Series Vaccination |
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding serious adverse events (SAEs). Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site. |
Within 30 days after vaccination |
|
Secondary |
Number of Participants With Serious Adverse Events During the Study |
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. |
Day 0 to Day 420 |
|
Secondary |
Number of Participants With Immediate Unsolicited Adverse Events After Booster Vaccination |
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. |
Within 30 minutes after booster vaccination |
|
Secondary |
Number of Participants With Solicited Injection Site or Systemic Reactions After Booster Vaccination |
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: tenderness, erythema, swelling, and extensive limb swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. |
Within 7 days after booster vaccination |
|
Secondary |
Number of Participants With Unsolicited Adverse Events After Booster Vaccination |
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding SAEs. Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site. |
Within 30 days after booster vaccination |
|