Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants (NCT NCT03550313)

Last Updated: 2021-11-30

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

565 participants

Primary outcome timeframe

Within 7 Days After Dose 1

Results posted on

2021-11-30

Participant Flow

A total of 569 infants had a signed informed consent document; 4 of these infants were deemed ineligible before randomization, and did not participate further. 565 participants were randomized in 3 reporting groups- 512 participants from 39 sites and 53 from 2 terminated sites (terminated due to serious quality issues). The study includes and reports valid data only from 512 participants. Out of these 512 participants, 484 received at least 1 vaccination.

Participant milestones

Participant milestones
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration Participants who received a dose of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Overall Study STARTED	192	187	186
Overall Study Vaccinated for Dose 1	171	147	166
Overall Study Vaccinated for Dose 2	159	135	153
Overall Study Vaccinated for Dose 3	151	127	146
Overall Study COMPLETED	95	77	72
Overall Study NOT COMPLETED	97	110	114

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration Participants who received a dose of complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	5	7	12
Overall Study Study terminated by sponsor	44	37	48
Overall Study No longer met eligibility criteria	3	5	6
Overall Study Withdrawal by parent/guardian	20	18	26
Overall Study Other	4	2	2
Overall Study Randomized but not vaccinated	3	23	2
Overall Study Sites terminated due to quality issues	18	17	18

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=171 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=147 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=166 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).	Total n=484 Participants Total of all reporting groups
Age, Continuous	65.9 Days STANDARD_DEVIATION 9.53 • n=5 Participants	95.1 Days STANDARD_DEVIATION 10.40 • n=7 Participants	64.9 Days STANDARD_DEVIATION 8.22 • n=5 Participants	74.4 Days STANDARD_DEVIATION 16.59 • n=4 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	80 Participants n=7 Participants	75 Participants n=5 Participants	240 Participants n=4 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	67 Participants n=7 Participants	91 Participants n=5 Participants	244 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	89 Participants n=5 Participants	70 Participants n=7 Participants	85 Participants n=5 Participants	244 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=5 Participants	77 Participants n=7 Participants	80 Participants n=5 Participants	238 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants	26 Participants n=7 Participants	31 Participants n=5 Participants	92 Participants n=4 Participants
Race (NIH/OMB) White	102 Participants n=5 Participants	90 Participants n=7 Participants	105 Participants n=5 Participants	297 Participants n=4 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	48 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=166 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=144 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=165 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Mild	16.3 Percentage of participants Interval 11.0 to 22.8	21.5 Percentage of participants Interval 15.1 to 29.1	18.2 Percentage of participants Interval 12.6 to 24.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Moderate	9.6 Percentage of participants Interval 5.6 to 15.2	4.9 Percentage of participants Interval 2.0 to 9.8	3.6 Percentage of participants Interval 1.3 to 7.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Severe	0 Percentage of participants Interval 0.0 to 2.2	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Any	25.9 Percentage of participants Interval 19.4 to 33.3	26.4 Percentage of participants Interval 19.4 to 34.4	21.8 Percentage of participants Interval 15.8 to 28.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Any	27.1 Percentage of participants Interval 20.5 to 34.5	22.2 Percentage of participants Interval 15.7 to 29.9	23.6 Percentage of participants Interval 17.4 to 30.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Mild	16.3 Percentage of participants Interval 11.0 to 22.8	13.9 Percentage of participants Interval 8.7 to 20.6	17.0 Percentage of participants Interval 11.6 to 23.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Moderate	10.2 Percentage of participants Interval 6.1 to 15.9	8.3 Percentage of participants Interval 4.4 to 14.1	5.5 Percentage of participants Interval 2.5 to 10.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Severe	0.6 Percentage of participants Interval 0.0 to 3.3	0 Percentage of participants Interval 0.0 to 2.5	1.2 Percentage of participants Interval 0.1 to 4.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at Injection Site: Any	59.6 Percentage of participants Interval 51.8 to 67.2	40.3 Percentage of participants Interval 32.2 to 48.8	50.3 Percentage of participants Interval 42.4 to 58.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at Injection Site: Mild	28.9 Percentage of participants Interval 22.2 to 36.4	28.5 Percentage of participants Interval 21.3 to 36.6	26.1 Percentage of participants Interval 19.5 to 33.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at Injection Site: Moderate	27.7 Percentage of participants Interval 21.1 to 35.2	11.1 Percentage of participants Interval 6.5 to 17.4	22.4 Percentage of participants Interval 16.3 to 29.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at Injection Site: Severe	3.0 Percentage of participants Interval 1.0 to 6.9	0.7 Percentage of participants Interval 0.0 to 3.8	1.8 Percentage of participants Interval 0.4 to 5.2

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=152 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=126 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=147 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Mild	22.4 Percentage of participants Interval 16.0 to 29.8	18.3 Percentage of participants Interval 11.9 to 26.1	21.1 Percentage of participants Interval 14.8 to 28.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Any	28.9 Percentage of participants Interval 21.9 to 36.8	20.6 Percentage of participants Interval 13.9 to 28.8	23.8 Percentage of participants Interval 17.2 to 31.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Moderate	6.6 Percentage of participants Interval 3.2 to 11.8	2.4 Percentage of participants Interval 0.5 to 6.8	2.7 Percentage of participants Interval 0.7 to 6.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.9	0 Percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Any	21.1 Percentage of participants Interval 14.9 to 28.4	16.7 Percentage of participants Interval 10.6 to 24.3	22.4 Percentage of participants Interval 16.0 to 30.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Mild	14.5 Percentage of participants Interval 9.3 to 21.1	14.3 Percentage of participants Interval 8.7 to 21.6	16.3 Percentage of participants Interval 10.7 to 23.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Moderate	6.6 Percentage of participants Interval 3.2 to 11.8	2.4 Percentage of participants Interval 0.5 to 6.8	6.1 Percentage of participants Interval 2.8 to 11.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Severe	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.9	0 Percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at Injection Site: Any	55.3 Percentage of participants Interval 47.0 to 63.3	23.8 Percentage of participants Interval 16.7 to 32.2	46.9 Percentage of participants Interval 38.7 to 55.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at Injection Site: Mild	31.6 Percentage of participants Interval 24.3 to 39.6	19.0 Percentage of participants Interval 12.6 to 27.0	27.9 Percentage of participants Interval 20.8 to 35.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at Injection Site: Moderate	21.7 Percentage of participants Interval 15.4 to 29.1	4.8 Percentage of participants Interval 1.8 to 10.1	18.4 Percentage of participants Interval 12.5 to 25.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at Injection Site: Severe	2.0 Percentage of participants Interval 0.4 to 5.7	0 Percentage of participants Interval 0.0 to 2.9	0.7 Percentage of participants Interval 0.0 to 3.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=143 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=120 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=138 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Any	25.2 Percentage of participants Interval 18.3 to 33.1	20.0 Percentage of participants Interval 13.3 to 28.3	22.5 Percentage of participants Interval 15.8 to 30.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Mild	23.1 Percentage of participants Interval 16.4 to 30.9	19.2 Percentage of participants Interval 12.6 to 27.4	18.1 Percentage of participants Interval 12.1 to 25.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Moderate	2.1 Percentage of participants Interval 0.4 to 6.0	0.8 Percentage of participants Interval 0.0 to 4.6	4.3 Percentage of participants Interval 1.6 to 9.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Severe	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 3.0	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Any	21.7 Percentage of participants Interval 15.2 to 29.3	14.2 Percentage of participants Interval 8.5 to 21.7	18.1 Percentage of participants Interval 12.1 to 25.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Mild	17.5 Percentage of participants Interval 11.6 to 24.7	11.7 Percentage of participants Interval 6.5 to 18.8	13.8 Percentage of participants Interval 8.5 to 20.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Moderate	4.2 Percentage of participants Interval 1.6 to 8.9	2.5 Percentage of participants Interval 0.5 to 7.1	3.6 Percentage of participants Interval 1.2 to 8.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Severe	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 3.0	0.7 Percentage of participants Interval 0.0 to 4.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at Injection Site: Any	39.9 Percentage of participants Interval 31.8 to 48.4	22.5 Percentage of participants Interval 15.4 to 31.0	35.5 Percentage of participants Interval 27.6 to 44.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at Injection Site: Mild	23.8 Percentage of participants Interval 17.1 to 31.6	17.5 Percentage of participants Interval 11.2 to 25.5	18.8 Percentage of participants Interval 12.7 to 26.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at Injection Site: Moderate	15.4 Percentage of participants Interval 9.9 to 22.4	5.0 Percentage of participants Interval 1.9 to 10.6	15.2 Percentage of participants Interval 9.7 to 22.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at Injection Site: Severe	0.7 Percentage of participants Interval 0.0 to 3.8	0 Percentage of participants Interval 0.0 to 3.0	1.4 Percentage of participants Interval 0.2 to 5.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=105 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=79 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=98 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Any	22.9 Percentage of participants Interval 15.2 to 32.1	19.0 Percentage of participants Interval 11.0 to 29.4	22.4 Percentage of participants Interval 14.6 to 32.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Mild	21.9 Percentage of participants Interval 14.4 to 31.0	15.2 Percentage of participants Interval 8.1 to 25.0	19.4 Percentage of participants Interval 12.1 to 28.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Moderate	1.0 Percentage of participants Interval 0.0 to 5.2	3.8 Percentage of participants Interval 0.8 to 10.7	3.1 Percentage of participants Interval 0.6 to 8.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Severe	0 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 4.6	0 Percentage of participants Interval 0.0 to 3.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Any	19.0 Percentage of participants Interval 12.0 to 27.9	13.9 Percentage of participants Interval 7.2 to 23.5	19.4 Percentage of participants Interval 12.1 to 28.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Mild	17.1 Percentage of participants Interval 10.5 to 25.7	8.9 Percentage of participants Interval 3.6 to 17.4	13.3 Percentage of participants Interval 7.3 to 21.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Moderate	1.9 Percentage of participants Interval 0.2 to 6.7	5.1 Percentage of participants Interval 1.4 to 12.5	6.1 Percentage of participants Interval 2.3 to 12.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Severe	0 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 4.6	0 Percentage of participants Interval 0.0 to 3.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at Injection Site: Any	35.2 Percentage of participants Interval 26.2 to 45.2	22.8 Percentage of participants Interval 14.1 to 33.6	28.6 Percentage of participants Interval 19.9 to 38.6
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at Injection Site: Mild	21.9 Percentage of participants Interval 14.4 to 31.0	16.5 Percentage of participants Interval 9.1 to 26.5	18.4 Percentage of participants Interval 11.3 to 27.5
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at Injection Site: Moderate	12.4 Percentage of participants Interval 6.8 to 20.2	6.3 Percentage of participants Interval 2.1 to 14.2	10.2 Percentage of participants Interval 5.0 to 18.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at Injection Site: Severe	1.0 Percentage of participants Interval 0.0 to 5.2	0 Percentage of participants Interval 0.0 to 4.6	0 Percentage of participants Interval 0.0 to 3.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=85 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Redness: Any	5.9 Percentage of participants Interval 1.9 to 13.2	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Redness: Mild	4.7 Percentage of participants Interval 1.3 to 11.6	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Redness: Moderate	1.2 Percentage of participants Interval 0.0 to 6.4	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Redness: Severe	0 Percentage of participants Interval 0.0 to 4.2	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Swelling: Any	9.4 Percentage of participants Interval 4.2 to 17.7	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Swelling: Mild	9.4 Percentage of participants Interval 4.2 to 17.7	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Swelling: Moderate	0 Percentage of participants Interval 0.0 to 4.2	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Swelling: Severe	0 Percentage of participants Interval 0.0 to 4.2	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Pain at Injection Site: Any	12.9 Percentage of participants Interval 6.6 to 22.0	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Pain at Injection Site: Mild	11.8 Percentage of participants Interval 5.8 to 20.6	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Pain at Injection Site: Moderate	1.2 Percentage of participants Interval 0.0 to 6.4	—	—
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Pain at Injection Site: Severe	0 Percentage of participants Interval 0.0 to 4.2	—	—

PRIMARY outcome

Timeframe: 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 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).

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=166 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=144 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=165 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased Appetite: Mild	19.3 Percentage of participants Interval 13.6 to 26.1	6.3 Percentage of participants Interval 2.9 to 11.5	14.5 Percentage of participants Interval 9.5 to 20.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >=38.0 degree C	12.7 Percentage of participants Interval 8.0 to 18.7	5.6 Percentage of participants Interval 2.4 to 10.7	9.1 Percentage of participants Interval 5.2 to 14.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >=38.0 degree C to 38.4 degree C	7.8 Percentage of participants Interval 4.2 to 13.0	3.5 Percentage of participants Interval 1.1 to 7.9	6.1 Percentage of participants Interval 2.9 to 10.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >38.4 degree C to 38.9 degree C	3.0 Percentage of participants Interval 1.0 to 6.9	0.7 Percentage of participants Interval 0.0 to 3.8	2.4 Percentage of participants Interval 0.7 to 6.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >38.9 degree C to 40.0 degree C	1.8 Percentage of participants Interval 0.4 to 5.2	1.4 Percentage of participants Interval 0.2 to 4.9	0.6 Percentage of participants Interval 0.0 to 3.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >40.0 degree C	0 Percentage of participants Interval 0.0 to 2.2	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased Appetite: Any	28.9 Percentage of participants Interval 22.2 to 36.4	15.3 Percentage of participants Interval 9.8 to 22.2	26.7 Percentage of participants Interval 20.1 to 34.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased Appetite: Moderate	7.2 Percentage of participants Interval 3.8 to 12.3	9.0 Percentage of participants Interval 4.9 to 14.9	10.3 Percentage of participants Interval 6.1 to 16.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Moderate	16.3 Percentage of participants Interval 11.0 to 22.8	9.7 Percentage of participants Interval 5.4 to 15.8	13.3 Percentage of participants Interval 8.5 to 19.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Severe	1.8 Percentage of participants Interval 0.4 to 5.2	1.4 Percentage of participants Interval 0.2 to 4.9	1.8 Percentage of participants Interval 0.4 to 5.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Any	70.5 Percentage of participants Interval 62.9 to 77.3	57.6 Percentage of participants Interval 49.1 to 65.8	63.6 Percentage of participants Interval 55.8 to 71.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Mild	25.3 Percentage of participants Interval 18.9 to 32.6	29.2 Percentage of participants Interval 21.9 to 37.3	23.6 Percentage of participants Interval 17.4 to 30.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Moderate	38.0 Percentage of participants Interval 30.5 to 45.8	23.6 Percentage of participants Interval 16.9 to 31.4	36.4 Percentage of participants Interval 29.0 to 44.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Severe	7.2 Percentage of participants Interval 3.8 to 12.3	4.9 Percentage of participants Interval 2.0 to 9.8	3.6 Percentage of participants Interval 1.3 to 7.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased Appetite: Severe	2.4 Percentage of participants Interval 0.7 to 6.1	0 Percentage of participants Interval 0.0 to 2.5	1.8 Percentage of participants Interval 0.4 to 5.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Any	59.6 Percentage of participants Interval 51.8 to 67.2	43.1 Percentage of participants Interval 34.8 to 51.6	53.3 Percentage of participants Interval 45.4 to 61.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Mild	41.6 Percentage of participants Interval 34.0 to 49.5	31.9 Percentage of participants Interval 24.4 to 40.2	38.2 Percentage of participants Interval 30.7 to 46.1

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=152 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=126 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=147 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >=38.0 degree C	25.7 Percentage of participants Interval 18.9 to 33.4	4.0 Percentage of participants Interval 1.3 to 9.0	15.6 Percentage of participants Interval 10.2 to 22.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >=38.0 degree C to 38.4 degree C	12.5 Percentage of participants Interval 7.7 to 18.8	3.2 Percentage of participants Interval 0.9 to 7.9	8.2 Percentage of participants Interval 4.3 to 13.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >38.4 degree C to 38.9 degree C	10.5 Percentage of participants Interval 6.1 to 16.5	0.8 Percentage of participants Interval 0.0 to 4.3	2.7 Percentage of participants Interval 0.7 to 6.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >38.9 degree C to 40.0 degree C	2.6 Percentage of participants Interval 0.7 to 6.6	0 Percentage of participants Interval 0.0 to 2.9	4.1 Percentage of participants Interval 1.5 to 8.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >40.0 degree C	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 2.9	0.7 Percentage of participants Interval 0.0 to 3.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Mild	32.2 Percentage of participants Interval 24.9 to 40.3	15.1 Percentage of participants Interval 9.3 to 22.5	25.9 Percentage of participants Interval 19.0 to 33.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased Appetite: Any	23.0 Percentage of participants Interval 16.6 to 30.5	12.7 Percentage of participants Interval 7.4 to 19.8	25.2 Percentage of participants Interval 18.4 to 33.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased Appetite: Mild	11.8 Percentage of participants Interval 7.2 to 18.1	8.7 Percentage of participants Interval 4.4 to 15.1	15.6 Percentage of participants Interval 10.2 to 22.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased Appetite: Moderate	9.9 Percentage of participants Interval 5.6 to 15.8	4.0 Percentage of participants Interval 1.3 to 9.0	9.5 Percentage of participants Interval 5.3 to 15.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased Appetite: Severe	1.3 Percentage of participants Interval 0.2 to 4.7	0 Percentage of participants Interval 0.0 to 2.9	0 Percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Any	48.7 Percentage of participants Interval 40.5 to 56.9	21.4 Percentage of participants Interval 14.6 to 29.6	42.9 Percentage of participants Interval 34.7 to 51.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Moderate	15.1 Percentage of participants Interval 9.8 to 21.8	6.3 Percentage of participants Interval 2.8 to 12.1	17.0 Percentage of participants Interval 11.3 to 24.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Severe	1.3 Percentage of participants Interval 0.2 to 4.7	0 Percentage of participants Interval 0.0 to 2.9	0 Percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Any	64.5 Percentage of participants Interval 56.3 to 72.1	44.4 Percentage of participants Interval 35.6 to 53.6	58.5 Percentage of participants Interval 50.1 to 66.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Mild	20.4 Percentage of participants Interval 14.3 to 27.7	21.4 Percentage of participants Interval 14.6 to 29.6	17.7 Percentage of participants Interval 11.9 to 24.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Moderate	40.8 Percentage of participants Interval 32.9 to 49.0	20.6 Percentage of participants Interval 13.9 to 28.8	36.1 Percentage of participants Interval 28.3 to 44.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Severe	3.3 Percentage of participants Interval 1.1 to 7.5	2.4 Percentage of participants Interval 0.5 to 6.8	4.8 Percentage of participants Interval 1.9 to 9.6

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=143 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=120 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=138 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased Appetite: Moderate	7.0 Percentage of participants Interval 3.4 to 12.5	5.8 Percentage of participants Interval 2.4 to 11.6	10.1 Percentage of participants Interval 5.7 to 16.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >38.9 degree C to 40.0 degree C	1.4 Percentage of participants Interval 0.2 to 5.0	0.8 Percentage of participants Interval 0.0 to 4.6	3.6 Percentage of participants Interval 1.2 to 8.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >=38.0 degree C	14.0 Percentage of participants Interval 8.8 to 20.8	5.8 Percentage of participants Interval 2.4 to 11.6	14.5 Percentage of participants Interval 9.1 to 21.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >=38.0 degree C to 38.4 degree C	6.3 Percentage of participants Interval 2.9 to 11.6	3.3 Percentage of participants Interval 0.9 to 8.3	8.0 Percentage of participants Interval 4.0 to 13.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >38.4 degree C to 38.9 degree C	5.6 Percentage of participants Interval 2.4 to 10.7	1.7 Percentage of participants Interval 0.2 to 5.9	2.9 Percentage of participants Interval 0.8 to 7.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >40.0 degree C	0.7 Percentage of participants Interval 0.0 to 3.8	0 Percentage of participants Interval 0.0 to 3.0	0 Percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased Appetite: Any	19.6 Percentage of participants Interval 13.4 to 27.0	18.3 Percentage of participants Interval 11.9 to 26.4	21.0 Percentage of participants Interval 14.5 to 28.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased Appetite: Mild	12.6 Percentage of participants Interval 7.6 to 19.2	12.5 Percentage of participants Interval 7.2 to 19.8	10.1 Percentage of participants Interval 5.7 to 16.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased Appetite: Severe	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 3.0	0.7 Percentage of participants Interval 0.0 to 4.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Any	43.4 Percentage of participants Interval 35.1 to 51.9	21.7 Percentage of participants Interval 14.7 to 30.1	45.7 Percentage of participants Interval 37.2 to 54.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Mild	29.4 Percentage of participants Interval 22.1 to 37.6	16.7 Percentage of participants Interval 10.5 to 24.6	32.6 Percentage of participants Interval 24.9 to 41.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Moderate	13.3 Percentage of participants Interval 8.2 to 20.0	3.3 Percentage of participants Interval 0.9 to 8.3	12.3 Percentage of participants Interval 7.3 to 19.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Severe	0.7 Percentage of participants Interval 0.0 to 3.8	1.7 Percentage of participants Interval 0.2 to 5.9	0.7 Percentage of participants Interval 0.0 to 4.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Any	57.3 Percentage of participants Interval 48.8 to 65.6	50.8 Percentage of participants Interval 41.6 to 60.1	53.6 Percentage of participants Interval 44.9 to 62.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Mild	25.2 Percentage of participants Interval 18.3 to 33.1	26.7 Percentage of participants Interval 19.0 to 35.5	23.9 Percentage of participants Interval 17.1 to 31.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Moderate	31.5 Percentage of participants Interval 24.0 to 39.8	21.7 Percentage of participants Interval 14.7 to 30.1	26.8 Percentage of participants Interval 19.6 to 35.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Severe	0.7 Percentage of participants Interval 0.0 to 3.8	2.5 Percentage of participants Interval 0.5 to 7.1	2.9 Percentage of participants Interval 0.8 to 7.3

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=105 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=79 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=98 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >=38.0 degree C	12.4 Percentage of participants Interval 6.8 to 20.2	0 Percentage of participants Interval 0.0 to 4.6	11.2 Percentage of participants Interval 5.7 to 19.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >=38.0 degree C to 38.4 degree C	7.6 Percentage of participants Interval 3.3 to 14.5	0 Percentage of participants Interval 0.0 to 4.6	4.1 Percentage of participants Interval 1.1 to 10.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >38.4 degree C to 38.9 degree C	1.9 Percentage of participants Interval 0.2 to 6.7	0 Percentage of participants Interval 0.0 to 4.6	4.1 Percentage of participants Interval 1.1 to 10.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >38.9 degree C to 40.0 degree C	1.9 Percentage of participants Interval 0.2 to 6.7	0 Percentage of participants Interval 0.0 to 4.6	3.1 Percentage of participants Interval 0.6 to 8.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >40.0 degree C	1.0 Percentage of participants Interval 0.0 to 5.2	0 Percentage of participants Interval 0.0 to 4.6	0 Percentage of participants Interval 0.0 to 3.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased Appetite: Any	20.0 Percentage of participants Interval 12.8 to 28.9	13.9 Percentage of participants Interval 7.2 to 23.5	23.5 Percentage of participants Interval 15.5 to 33.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased Appetite: Mild	14.3 Percentage of participants Interval 8.2 to 22.5	10.1 Percentage of participants Interval 4.5 to 19.0	13.3 Percentage of participants Interval 7.3 to 21.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased Appetite: Moderate	4.8 Percentage of participants Interval 1.6 to 10.8	3.8 Percentage of participants Interval 0.8 to 10.7	9.2 Percentage of participants Interval 4.3 to 16.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased Appetite: Severe	1.0 Percentage of participants Interval 0.0 to 5.2	0 Percentage of participants Interval 0.0 to 4.6	1.0 Percentage of participants Interval 0.0 to 5.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Any	33.3 Percentage of participants Interval 24.4 to 43.2	20.3 Percentage of participants Interval 12.0 to 30.8	29.6 Percentage of participants Interval 20.8 to 39.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Mild	25.7 Percentage of participants Interval 17.7 to 35.2	17.7 Percentage of participants Interval 10.0 to 27.9	20.4 Percentage of participants Interval 12.9 to 29.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Moderate	7.6 Percentage of participants Interval 3.3 to 14.5	2.5 Percentage of participants Interval 0.3 to 8.8	8.2 Percentage of participants Interval 3.6 to 15.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Severe	0 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 4.6	1.0 Percentage of participants Interval 0.0 to 5.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Any	60.0 Percentage of participants Interval 50.0 to 69.4	53.2 Percentage of participants Interval 41.6 to 64.5	46.9 Percentage of participants Interval 36.8 to 57.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Mild	24.8 Percentage of participants Interval 16.9 to 34.1	31.6 Percentage of participants Interval 21.6 to 43.1	21.4 Percentage of participants Interval 13.8 to 30.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Moderate	34.3 Percentage of participants Interval 25.3 to 44.2	20.3 Percentage of participants Interval 12.0 to 30.8	23.5 Percentage of participants Interval 15.5 to 33.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Severe	1.0 Percentage of participants Interval 0.0 to 5.2	1.3 Percentage of participants Interval 0.0 to 6.9	2.0 Percentage of participants Interval 0.2 to 7.2

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=85 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Fever: >=38.0 degree C	5.9 Percentage of participants Interval 1.9 to 13.2	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Fever: >=38.0 degree C to 38.4 degree C	3.5 Percentage of participants Interval 0.7 to 10.0	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Fever: >38.4 degree C to 38.9 degree C	1.2 Percentage of participants Interval 0.0 to 6.4	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Fever: >38.9 degree C to 40.0 degree C	1.2 Percentage of participants Interval 0.0 to 6.4	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Fever: >40.0 degree C	0 Percentage of participants Interval 0.0 to 4.2	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Decreased Appetite: Any	11.8 Percentage of participants Interval 5.8 to 20.6	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Decreased Appetite: Mild	8.2 Percentage of participants Interval 3.4 to 16.2	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Decreased Appetite: Moderate	1.2 Percentage of participants Interval 0.0 to 6.4	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Decreased Appetite: Severe	2.4 Percentage of participants Interval 0.3 to 8.2	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Drowsiness: Any	21.2 Percentage of participants Interval 13.1 to 31.4	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Drowsiness: Mild	17.6 Percentage of participants Interval 10.2 to 27.4	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Drowsiness: Moderate	2.4 Percentage of participants Interval 0.3 to 8.2	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Drowsiness: Severe	1.2 Percentage of participants Interval 0.0 to 6.4	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Irritability: Any	30.6 Percentage of participants Interval 21.0 to 41.5	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Irritability: Mild	15.3 Percentage of participants Interval 8.4 to 24.7	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Irritability: Moderate	12.9 Percentage of participants Interval 6.6 to 22.0	—	—
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Irritability: Severe	2.4 Percentage of participants Interval 0.3 to 8.2	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=171 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=147 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=166 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3	57.9 Percentage of participants Interval 50.1 to 65.4	65.3 Percentage of participants Interval 57.0 to 73.0	56.6 Percentage of participants Interval 48.7 to 64.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=110 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=85 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=101 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4	23.6 Percentage of participants Interval 16.1 to 32.7	15.3 Percentage of participants Interval 8.4 to 24.7	25.7 Percentage of participants Interval 17.6 to 35.4

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=88 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose	18.2 Percentage of participants Interval 10.8 to 27.8	—	—

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=171 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=147 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=166 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study	4.1 Percentage of participants Interval 1.7 to 8.3	2.7 Percentage of participants Interval 0.7 to 6.8	5.4 Percentage of participants Interval 2.5 to 10.0

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=171 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=147 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=166 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study	7.6 Percentage of participants Interval 4.1 to 12.6	3.4 Percentage of participants Interval 1.1 to 7.8	7.2 Percentage of participants Interval 3.8 to 12.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=128 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=107 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=109 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 8	2.90 microgram per milliliter Interval 2.47 to 3.39	5.14 microgram per milliliter Interval 4.41 to 5.99	0.03 microgram per milliliter Interval 0.03 to 0.04
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 10A	2.55 microgram per milliliter Interval 1.95 to 3.34	4.52 microgram per milliliter Interval 3.59 to 5.69	0.03 microgram per milliliter Interval 0.03 to 0.04
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 11A	4.37 microgram per milliliter Interval 3.57 to 5.34	8.88 microgram per milliliter Interval 7.25 to 10.87	0.01 microgram per milliliter Interval 0.01 to 0.02
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 12F	1.92 microgram per milliliter Interval 1.58 to 2.34	3.35 microgram per milliliter Interval 2.75 to 4.07	0.02 microgram per milliliter Interval 0.02 to 0.02
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 15B	9.12 microgram per milliliter Interval 7.54 to 11.04	14.86 microgram per milliliter Interval 12.65 to 17.44	0.05 microgram per milliliter Interval 0.04 to 0.06
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 22F	9.25 microgram per milliliter Interval 7.5 to 11.41	23.94 microgram per milliliter Interval 19.88 to 28.82	0.01 microgram per milliliter Interval 0.01 to 0.01
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 Serotype 33F	3.40 microgram per milliliter Interval 2.75 to 4.21	4.83 microgram per milliliter Interval 3.99 to 5.84	0.06 microgram per milliliter Interval 0.05 to 0.06

SECONDARY outcome

Timeframe: 1 Month after Dose 3

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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=128 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=107 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=109 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 8	98.4 Percentage of participants Interval 94.5 to 99.8	100.0 Percentage of participants Interval 96.6 to 100.0	1.8 Percentage of participants Interval 0.2 to 6.5
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 10A	89.8 Percentage of participants Interval 83.3 to 94.5	98.1 Percentage of participants Interval 93.4 to 99.8	2.8 Percentage of participants Interval 0.6 to 7.8
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 11A	96.9 Percentage of participants Interval 92.2 to 99.1	99.1 Percentage of participants Interval 94.9 to 100.0	0.9 Percentage of participants Interval 0.0 to 5.0
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 12F	95.3 Percentage of participants Interval 90.1 to 98.3	98.1 Percentage of participants Interval 93.4 to 99.8	0.0 Percentage of participants Interval 0.0 to 3.3
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 15B	96.9 Percentage of participants Interval 92.2 to 99.1	100.0 Percentage of participants Interval 96.6 to 100.0	6.4 Percentage of participants Interval 2.6 to 12.8
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 22F	96.9 Percentage of participants Interval 92.2 to 99.1	100.0 Percentage of participants Interval 96.6 to 100.0	0.0 Percentage of participants Interval 0.0 to 3.3
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 Serotype 33F	96.1 Percentage of participants Interval 91.1 to 98.7	99.1 Percentage of participants Interval 94.9 to 100.0	4.6 Percentage of participants Interval 1.5 to 10.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: c7vPnC and Prevnar 13 Co-administration n=76 Participants Participants who received a dose of c7vPnC in one leg at 2, 4, 6 and 12 months of age (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 months of age in another leg.	Group 2: c7vPnC and Prevnar 13 Staggered Administration n=57 Participants Participants who received a dose of c7vPnC at 3, 5, 7, and 13 months of age in one leg (Dose 1, 2, 3, and 4 respectively) and Prevnar 13 at 2, 4, 6, and 12 month of age in another leg.	Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose n=68 Participants Participants who received a dose of Prevnar 13 at 2, 4, 6, and 12 months of age (Dose 1, 2, 3, and 4 respectively) and a dose of c7vPnC at 13 months of age (Supplemental Dose).
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 22F	25.68 microgram per milliliter Interval 21.33 to 30.91	29.92 microgram per milliliter Interval 24.21 to 36.98	0.01 microgram per milliliter Interval 0.01 to 0.02
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 8	3.79 microgram per milliliter Interval 3.1 to 4.62	3.05 microgram per milliliter Interval 2.46 to 3.78	0.08 microgram per milliliter Interval 0.06 to 0.12
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 10A	12.77 microgram per milliliter Interval 10.16 to 16.06	7.15 microgram per milliliter Interval 5.26 to 9.72	0.04 microgram per milliliter Interval 0.03 to 0.04
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 11A	8.25 microgram per milliliter Interval 6.72 to 10.12	7.12 microgram per milliliter Interval 5.53 to 9.15	0.02 microgram per milliliter Interval 0.01 to 0.04
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 12F	3.15 microgram per milliliter Interval 2.64 to 3.74	2.57 microgram per milliliter Interval 2.08 to 3.19	0.03 microgram per milliliter Interval 0.02 to 0.03
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 15B	24.56 microgram per milliliter Interval 21.23 to 28.41	17.70 microgram per milliliter Interval 14.31 to 21.89	0.06 microgram per milliliter Interval 0.04 to 0.07
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 Serotype 33F	5.38 microgram per milliliter Interval 4.47 to 6.48	3.95 microgram per milliliter Interval 3.16 to 4.93	0.06 microgram per milliliter Interval 0.05 to 0.08

Adverse Events

Group 1: c7vPnC and Prevnar 13 Co-administration

Serious events: 7 serious events

Other events: 163 other events

Deaths: 0 deaths

Group 2: c7vPnC and Prevnar 13 Staggered Administration

Serious events: 4 serious events

Other events: 138 other events

Deaths: 0 deaths

Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose

Serious events: 9 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER