A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of a Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 11 Through 15 Months of Age Who Previously Received the PCV10 Primary Series

Percentage of Participants With Local Reactions Within 7 Days After Dose 1

时间窗: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)

Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 0 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, severe: \>7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.

Percentage of Participants With Local Reactions Within 7 Days After Dose 2

时间窗: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)

Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 0 to 2.0 cm, moderate: \>2.0 to 7.0 cm, severe: \>7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.

Percentage of Participants With Systemic Events Within 7 Days After Dose 1

时间窗: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)

Fever (oral temperature \>= 38 degree Celsius \[degC\]) was categorized as \>=38.0-38.4 degC, \>38.4-38.9 degC, \>38.9-40.0 degC and \>40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.

Percentage of Participants With Systemic Events Within 7 Days After Dose 2

时间窗: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)

Fever (oral temperature \>= 38 degC) was categorized as \>=38.0-38.4 degC, \>38.4-38.9 degC, \>38.9-40.0 degC and \>40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.

Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2

时间窗: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.

Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2

时间窗: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator.