Trial · NCT01545375
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 | Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified according to protocol cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | From the administration of dose 1 up to Month 22 | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Occurrence of Any Draining Acute Otitis Media (AOM) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | From the administration of dose 1 up to Month 22 | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode. | Any time from 2 weeks after the administration of dose 3 up to Month 22 | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Episodes per person-year | NUMBER |
| SECONDARY | Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort | At 7 months of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22) | Analysis was performed on the Total vaccinated cohort for carriage which included around 400 subjects not included in the immuno/reacto sub-cohort, who had received at least one vaccination dose and for whom data concerning carriage outcome measures were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively | The analysis was to be performed on the according to protocol cohort for immunogenicity. But inhibition of Ply hemolysis activity was not evaluated due to assay stability issues. | ||
| SECONDARY | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort | 1 month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)], 1 month post-booster dose [Post-booster(Month 11)], 12 months post-booster dose [Post-booster(Month 22)] | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Vaccine-related Serotypes 6C | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] | The analysis was to be performed on the ATP cohort for immunogenicity. But no analysis was performed for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. | ||
| SECONDARY | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C | One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort | Within the 4-day (Days 0-3) post-primary vaccination period following each dose | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort | Within the 4-day (Days 0-3) post-booster vaccination period | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01545375/outcomes