Trial · NCT00385255
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | At Month 1 post-Boostrix® vaccination | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively. |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | At Month 1 post-Boostrix® vaccination | The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA). |
| Primary | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). |
| Primary | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | At Month 1 post-Fluarix® vaccination | The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40. |
| Primary | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | At Month 1 post-Fluarix® vaccination | Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer. |
| Secondary | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | At Month 1 post-Boostrix® vaccination | A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL. |
| Secondary | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | At Day 0 and Month 1 post-Boostrix® vaccination | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL). |
| Secondary | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | At Day 0 and Month 1 post-Boostrix® vaccination | Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). |
| Secondary | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | At Month 1 post-Boostrix® vaccination | Booster responses for anti-D and anti-T antibodies are defined as: For initially seronegative subjects \[pre-vaccination concentration below (\<) cut-off 0.1 IU/mL\]: antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL), one month after vaccination with Boostrix®; For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with Boostrix®. |
| Secondary | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | Booster responses for anti-PT, anti-FHA and anti-PRN are defined as: For initially seronegative subjects (pre-vaccination concentration \< cut-off of 5 EL.U/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL), one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with Boostrix®. |
| Secondary | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | At Month 1 post-Fluarix® vaccination | Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs). |
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0. |
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain, muscle aches and shivering. Any = occurrence of the symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day period (Day 0-30) following each vaccination, up to 2 months | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Throughout the whole study period (from Day 0 to Month 2) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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