20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From Dose 1 to 1 Month after Dose 3

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From Dose 4 to 1 Month after Dose 4

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants who received Dose 4.

Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

Time frame: Within 7 Days after Dose 1

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 1.

Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

Time frame: Within 7 Days after Dose 2

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 2.

Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

Time frame: Within 7 Days after Dose 3

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 3.

Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

Time frame: Within 7 Days after Dose 4

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 4.

An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.

Time frame: From Dose 1 to 6 Months after Dose 4

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.

A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events.

Time frame: From Dose 1 to 6 Months after Dose 4

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.

Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days after Dose 1

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 1.

Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days after Dose 2

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 2.

Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days after Dose 3

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 3.

Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Time frame: Within 7 Days after Dose 4

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 4.