Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Primary outcomes

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

   Time frame: Baseline (Day 1) up to Day 29

   An AE was any untoward medical occurrence in a participant who received study drug 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 or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.

2. Duration of Adverse Events (AEs)

   Time frame: Baseline (Day 1) up to Day 29

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.

3. Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity

   Time frame: Baseline (Day 1) up to Day 29

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.

4. Number of Participants With Outcome in Response to Adverse Events (AEs)

   Time frame: Baseline (Day 1) up to Day 29

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.

5. Number of Participants Who Discontinued Due to Adverse Events (AEs)

   Time frame: Baseline (Day 1) up to Day 29

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

6. Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug

   Time frame: Baseline (Day 1) up to Day 29

   Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.