13vPnC vs Placebo: Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.000781 | 0.000556 | 0.0011 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00142 | 0.0011 | 0.00183 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000639 | -0.0011 | -0.000192 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.55 | 0.36 | 0.841 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.55 | 0.359 | 0.841 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on 13vPnC than on Placebo | 1,570 | 906 | 5,220 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 13vPnC | Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. | 33 | 42,240 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1. | 60 | 42,256 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP) | ClinicalTrials.gov |
| Description | CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature \>38.0 degrees C or \<36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (\>10\*10\^9 white blood cells/liter or \>15% bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae. | ClinicalTrials.gov |
| Time frame | Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years) | ClinicalTrials.gov |
| Population | PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults | ClinicalTrials.gov |
| NCT number | NCT00744263 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Pneumonia, Pneumococcal, Pneumococcal Infections, 13-valent Pneumococcal Vaccine | ClinicalTrials.gov |
| Interventions | VACCINE: placebo, VACCINE: 13-valent pneumococcal conjugate vaccine | ClinicalTrials.gov |
| Lead sponsor | Pfizer | ClinicalTrials.gov |
| Results first posted | 2014-10-06 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00744263?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.