Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

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

Time frame: From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

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

Time frame: From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)

Population: Dose 4 safety analysis set included participants who received Dose 4 and had safety data between Dose 4 and 1 month after Dose 4 for Groups 1 and 2 and had safety data between Dose 4 and Supplemental Dose for Group 3. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.

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

Time frame: From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)

Population: Supplemental dose safety analysis set included participants who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental dose. Since supplemental dose was received by participants in reporting arm Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose, hence data collected and reported for it only and not collected for Group 1 and 2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). 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 (greater than \[\>\] 0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Dose 1

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 1 in the overall safety population. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3.

Local reactions were recorded using an electronic diary by participant's LAR. 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 (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Dose 2

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after vaccination in the overall safety population. Dose 2 was second dose of c7vPnC in Group 1 and Group 2, and second dose of Prevnar 13 in Group 3.

Local reactions were recorded using an electronic diary by participant's LAR. 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 (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Dose 3

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after vaccination in the overall safety population. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

Local reactions were recorded using an electronic diary by participant's LAR. 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 (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Dose 4

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after vaccination in the overall safety population. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.

Local reactions were recorded using an electronic diary by participant's LAR. 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 (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Time frame: Within 7 Days After Supplemental Dose

Population: Participants received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Since supplemental dose was received by participants in reporting arm Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose, hence data collected and reported for it only and not collected for Group 1 and 2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

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

Time frame: From Dose 1 to End of the Study (up to duration of 17 months)

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

Time frame: From Dose 1 to End of the Study (up to duration of 17 months)

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3.

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (\>=) 38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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).

Time frame: Within 7 Days After Dose 1

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 1 in overall safety population. Dose 1 was first dose of c7vPnC in Group 1 and Group 2, and first dose of Prevnar 13 in Group 3.

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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).

Time frame: Within 7 Days After Dose 2

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 2 in overall safety population. Dose 2 was second dose of c7vPnC in Group 1 and Group 2, and second dose of Prevnar 13 in Group 3.

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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).

Time frame: Within 7 Days After Dose 3

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 3 in overall safety population. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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).

Time frame: Within 7 Days After Dose 4

Population: The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study. Here, Overall Number of Participants Analyzed signifies number of participants with any e-diary data reported after Dose 4 in overall safety population. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.

Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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).

Time frame: Within 7 Days After Supplemental Dose

Population: Supplemental dose safety analysis set included participants who received Supplemental Dose and had safety data between Supplemental Dose and 1 month after Supplemental Dose. Since supplemental dose was received by participants in reporting arm Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose, hence data collected and reported for it only and not collected for Group 1 and 2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

Percentage of participants with pre-specified IgG concentration (\>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

Time frame: 1 Month after Dose 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 Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, 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, and had no major protocol deviations.

IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.

Time frame: 1 Month After Dose 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 Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, 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, and had no major protocol deviations.

IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.

Time frame: 1 Month After Dose 4

Population: Dose 4 evaluable immunogenicity population: eligible participants, randomly assigned to receive vaccine, aged 42-98 days on the day of Dose 1 for Groups 1 and 3 or aged 63 to 133 days on the day of Dose 1 for Group 2, 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, and had no major protocol deviations.