Trial · NCT01235949
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL). |
| Primary | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | One month after primary immunization (At Month 3) | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. |
| Primary | Antibody Concentrations Against Protein D (Anti-PD) | One month after primary immunization (At Month 3) | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. |
| Secondary | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after primary immunization (At Month 3) | Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. |
| 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 | Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). |
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). |
| 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 | Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | During the entire study period (Month 0 to 10) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) following each primary vaccination dose | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) following booster vaccination | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. |
| Secondary | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Prior to (Month 9) and one month after booster vaccination (Month 10) | Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL. |
| Secondary | Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes | One month after primary immunization (Month 3) | OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8. |
| Secondary | Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes | Prior to (Month 9) and one month after booster vaccination (Month 10) | OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (\>) 1.0 E10. |
| Secondary | Antibody Concentrations Against Protein D (Anti-PD) | Prior to (Month 9) and one month after booster vaccination (Month 10) | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL. |
| Secondary | Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids | One month after primary immunization (Month 3) | Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL. |
| Secondary | Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids | Prior to (Month 9) and one month after booster vaccination (Month 10) | Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL. |
| Secondary | Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) | One month after primary immunization (Month 3) | Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL. |
| 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) | Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL. |
| Secondary | Antibody Concentrations Against Hepatitis B Surface Antigen (HBs) | One month after primary immunization (Month 3) | Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL. |
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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