Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.

Time frame: From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3.

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

Time frame: From Vaccination 4 to 1 month after Vaccination 4

Population: Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4.

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 days after Vaccination 1

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 days after Vaccination 2

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 days after Vaccination 3

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 days after Vaccination 4

Population: Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

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

Time frame: From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)

Population: Overall safety analysis set included all participants who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study.

An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.

Time frame: From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)

Population: Overall safety analysis set included all participants who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study.

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 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 (disabled, 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 Vaccination 1

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 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 (disabled, 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 Vaccination 2

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 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 (disabled, 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 Vaccination 3

Population: Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 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 (disabled, 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 Vaccination 4

Population: Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, Overall Number of Participants Analyzed =participants evaluable for this outcome measure.

Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per milliliter, for serotype 5: \>=0.23 microgram per milliliter, for serotype 6B: \>=0.10 microgram per milliliter and for serotype 19A: \>=0.12 microgram per milliliter.

Time frame: 1 month after Vaccination 3

Population: Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of first vaccination, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, had not received prohibited vaccines before blood draw at 1 month after Dose 3, and had no major protocol deviations.

IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Time frame: 1 Month after Vaccination 4

Population: Dose 4 evaluable immunogenicity population: eligible participants, randomly assigned to receive vaccine, aged 42-98 days on day of first vaccination, received all 4 doses of assigned vaccine, with Dose 4 received in defined window (365-386 days of age), had valid determinate IgG concentration for at least 1 serotype 1 month post dose 4,had blood collection within 27-56 days post Dose 4,had not received prohibited vaccines before blood draw at 1 month post Dose 4,had no major protocol deviations.

IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Time frame: 1 month after Vaccination 3

Population: Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of first vaccination, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, had not received prohibited vaccines before blood draw at 1 month after Dose 3, and had no major protocol deviations.