Trial · NCT01545375
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 | 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP \[AAP, 2004\], as per the judgment of a treating physician or equivalent licensed medical professional: A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear\[s\] that resulted in interference with or precluded normal activity or sleep). |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record. |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional: 1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is indicated by any of the following: a) Bulging of tympanic membrane, b) Limited or absent mobility of tympanic membrane, c) Air-fluid level behind tympanic membrane, d) Otorrhea OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane. |
| Secondary | Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | From the administration of dose 1 up to Month 22 | Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology. |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF. |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF. |
| Secondary | Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | From the administration of dose 1 up to Month 22 | AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode. |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T\[year)\]). ALRI was defined by the presence of tachypnea (respiratory rate \>50 amongst children 2 to 12 months of age, and respiratory rate \>40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds. |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T\[year)\]). ALRI was defined by the presence of tachypnea (respiratory rate \>50 amongst children 2 to 12 months of age, and respiratory rate \>40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds. |
| 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 | Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T\[year)\]). A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record. |
| 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) | Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed. |
| 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 | Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies. |
| 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 | 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)] | Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. |
| 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)] | Antibody concentrations were measured by Electro-chemiluminescence assay (ECL), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was a serotype-specific antibody concentration higher than or equal to (≥) LLOQ (Lower Limit of Quantification) expressed in µg/mL: 0.08 for Anti-1; 0.075 for anti-3; 0.061 for Anti-4; 0.198 for Anti-5; 0.111 for Anti-6A and Anti-18C; 0.102 for Anti-6B; 0.063 for Anti-7F; 0.066 for Anti-9V; 0.160 for Anti-14; 0.199 for Anti-19A; 0.163 for Anti-19F; 0.073 for Anti-23F. |
| 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)] | No analysis was performed on antibody concentrations against vaccine-related 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)] | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) LLOQ: 8 for OPA-1, OPA-3 and OPA-6B; 33 for OPA-4, and OPA-14; 50 for OPA-5; 151 for OPA-6A; 330 for OPA-7F; 275 for OPA-9V; 11 for OPA-18C; 143 for OPA-19A; 36 for OPA-19F; 101 for OPA-23F. |
| 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)] | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine-related pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 145. |
| 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 | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. |
| 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 | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. |
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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