Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults

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 greater than (\>) 38.0 degrees Celsius (C) or less than (\<) 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 percent (%) bands), C-reactive protein level \>3 times upper limit of normal, hypoxemia with partial oxygen pressure \<60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).

Time frame: Baseline up to occurrence of first episode of 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)

Population: Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(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.

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.

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)

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.

VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).

Time frame: Baseline up to occurrence of first episode of VT-IPD, 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)

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.

Deaths collected throughout the case acquisition period were presented.

Time frame: From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)

Population: Safety population included all participants who received study vaccine and who had any safety data.

Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.

Time frame: From 1 month after vaccination up to 6 months after vaccination

Population: Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.

Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.

Time frame: Within 7 days after vaccination

Population: Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.

Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain \[new muscle/joint pain\], aggravated generalized muscle/joint pain \[aggravated muscle/joint pain\], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(\<38 degrees C); Mild(greater than or equal to \[\>=\]38 to \<38.5 degrees C); Moderate(\>=38.5 to \<39 degrees C); Severe(\>=39 to less than or equal to \[\<=\]40 degrees C); Potentially life threatening (\>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours \[hrs\]); Moderate(\>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(\>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.

Time frame: Within 7 days after vaccination

Population: Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.