20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degree Celsius (C), and categorized as >=37.5 to 38.4 degree C, greater than (>)38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

A serious AE 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.

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.

Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ.

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.

20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).

GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population.

GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.

GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.