Trial · NCT01235949
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | One month after primary immunization (At Month 3) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | One month after primary immunization (At Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Antibody Concentrations Against Protein D (Anti-PD) | One month after primary immunization (At Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after primary immunization (At Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Serious Adverse Events (SAEs) | During the entire study period (Month 0 to 10) | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one vaccine dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) following each primary vaccination dose | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) following booster vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose. | Subjects | NUMBER |
| SECONDARY | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Prior to (Month 9) and one month after booster vaccination (Month 10) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes | One month after primary immunization (Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results or antibodies against at least one study vaccine antigen component after vaccination were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes | Prior to (Month 9) and one month after booster vaccination (Month 10) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Protein D (Anti-PD) | Prior to (Month 9) and one month after booster vaccination (Month 10) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids | One month after primary immunization (Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids | Prior to (Month 9) and one month after booster vaccination (Month 10) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) | One month after primary immunization (Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) | Prior to (Month 9) and one month after booster vaccination (Month 10) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Hepatitis B Surface Antigen (HBs) | One month after primary immunization (Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | mIU/mL | GEOMETRIC_MEAN |
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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