13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters \[cm\]), Moderate (5.1 to 10.0 cm), Severe (\>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).

Time frame: Within 14 days after vaccination

Population: Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in \>1 category.

Systemic events reported using electronic diary. Fever-Any:\>=38 degrees Celsius (C), Mild (M):\>=38 to \<38.5 degrees C, Moderate(Mod):\>=38.5 to \<39 degrees C, Severe (S):\>=39 to \<=40 degrees C, Potentially life threatening:\>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:\>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:\>=6/d. All reports of fever \>40 degrees C were confirmed as data entry errors.

Time frame: Within 14 days after vaccination

Population: Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in \>1 category.

An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: Baseline up to 1 Month (28 to 42 days) after vaccination

Population: Safety Population included all participants who received the vaccine.

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5\*limit of detection (LOD \[8\]) = (titer of 4) for the purpose of calculating the OPA GMT.

Time frame: One month (28 to 42 days) after vaccination

Population: Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.

Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.

Time frame: One month (28 to 42 days) after vaccination

Population: EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.

Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Time frame: Pre-vaccination to 1 month (28 to 42 days) after vaccination

Population: EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here N signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination.