Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00373958

Enrollment

666

Registered

2006-09-08

Start date

2006-09-30

Completion date

2008-06-30

Last updated

2013-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccines, Pneumococcal

Brief summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.

Interventions

BIOLOGICAL13 valent pneumococcal conjugate vaccine

1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

BIOLOGICAL7vPnc pneumococcal conjugate vaccine

1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

42 Days to 98 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy 2-month-old infants. * Available for the entire study period.

Exclusion criteria

* Previous vaccination with any vaccine before the start of the study. * Known contraindication to vaccination.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	One month after the 3-dose infant series (7 months of age)	Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	1 Month After the Toddler Dose	Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	One Month After the Infant Series (7 months of age)	Predefined Antibody Levels for Haemophilus Influenzae Type b (\[Hib\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \[IU\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \[FHA\] 40.5 Elisa Units \[EU\]/mL, Pertussis toxoid \[PT\] 16.5 EU/mL, Pertussis pertactin \[PRN\] 26 EU/mL).
Percentage of Participants Reporting Pre-specified Systemic Events	Within 7 days after each dose	Systemic events (any fever \[Fv\] ≥ 38 degrees Celsius \[C\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \[urticaria\], use of antipyretic medication \[med\] to treat or prevent symptoms \[sx\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-specified Local Reactions	Within 7 days after each dose	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\[Sig.\], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (\[Mod.\], 2.5 to 7.0 cm); Severe (\[Sev.\], \> 7.0 cm). Participants may have been represented in more than 1 category.

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	One month after toddler dose (13 to 16 months of age)	—
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	one month after the infant series and the toddler dose	Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	one month after the toddler dose	—
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	one month after the toddler dose	Normalization was performed for unit of measure index value as Index Value of 1.00 = 10 mIU/mL.
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	one month after the toddler dose	—
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	One month after infant series and one month after toddler dose	Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Countries

United States

Participant flow

Recruitment details

Participants were recruited in the United States from September 2006 to January 2008.

Pre-assignment details

Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.

Participants by arm

Arm	Count
13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).	334
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).	332
Total	666

Withdrawals & dropouts

Period	Reason	FG000	FG001
Infant Series	Adverse Event	3	1
Infant Series	Child relocated	1	0
Infant Series	Consent was not received	1	0
Infant Series	Failed to return	8	13
Infant Series	Lost Kaiser coverage	4	0
Infant Series	Lost to Follow-up	6	5
Infant Series	Physician Decision	1	1
Infant Series	Protocol Violation	3	7
Infant Series	Withdrawal by Subject	13	15
Toddler Dose	Failed to return	1	2
Toddler Dose	Lost to Follow-up	5	8
Toddler Dose	Protocol Violation	0	1
Toddler Dose	Withdrawal by Subject	2	2
Toddler Dose	Withdrawn after infant series	22	25

Baseline characteristics

Characteristic	13vPnC	7vPnC	Total
Age Continuous	2.1 months STANDARD_DEVIATION 0.3	2.1 months STANDARD_DEVIATION 0.3	2.1 months STANDARD_DEVIATION 0.3
Sex: Female, Male Female	165 Participants	139 Participants	304 Participants
Sex: Female, Male Male	169 Participants	193 Participants	362 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	272 / 332	263 / 331	31 / 332	29 / 330	183 / 267	163 / 258	11 / 330	10 / 329
serious Total, serious adverse events	17 / 332	16 / 331	5 / 332	7 / 330	3 / 267	4 / 258	9 / 330	5 / 329

Outcome results

Primary

Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose

Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Time frame: 1 Month After the Toddler Dose

Population: Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 9V (n=234,223)	2.62 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 1 (n=235,223)	5.06 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 18C (n=236,223)	3.20 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 3 (n=232,223)	0.94 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 6B (n=234,223)	11.53 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 5 (n=235,223)	3.72 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 19F (n=235,223)	6.60 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 6A (n=235,223)	8.20 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 14 (n=235,223)	9.11 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 7F (n=235,223)	5.67 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 23F (n=234,222)	5.07 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 19A (n=236,223)	8.55 μg/mL
13vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 4 (n=235,223)	3.73 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 19A (n=236,223)	3.54 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 4 (n=235,223)	5.49 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 6B (n=234,223)	15.63 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 9V (n=234,223)	3.63 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 14 (n=235,223)	12.72 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 18C (n=236,223)	4.70 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 19F (n=235,223)	5.60 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Common Serotypes - Serotype 23F (n=234,222)	7.84 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 1 (n=235,223)	0.03 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 3 (n=232,223)	0.07 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 5 (n=235,223)	0.55 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 6A (n=235,223)	1.87 μg/mL
7vPnC	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	Additional Serotypes - Serotype 7F (n=235,223)	0.05 μg/mL

Comparison: For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.57, 0.8]

Comparison: For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.61, 0.89]

Comparison: For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.62, 0.85]

Comparison: For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.6, 0.86]

Comparison: For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.57, 0.81]

Comparison: For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.98, 1.41]

Comparison: For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.54, 0.78]

Primary

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Time frame: One month after the 3-dose infant series (7 months of age)

Population: Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.

Arm	Measure	Group	Value (NUMBER)
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 9V (n=252,252)	90.5 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 1 (n=252,248)	95.6 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 18C (n=252,252)	96.8 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 3 (n=249,241)	63.5 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 6B (n=252,250)	87.3 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 5 (n=252,197)	89.7 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 19F (n=252,251)	98.0 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 6A (n=252,240)	96.0 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 14 (n=251,252)	97.6 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 7F (n=252,248)	98.4 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 23F (n=252,252)	90.5 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 19A (n=251,238)	98.4 percentage of participants
13vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 4 (n=252,251)	94.4 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 19A (n=251,238)	86.6 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 4 (n=252,251)	98.0 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 6B (n=252,250)	92.8 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 9V (n=252,252)	98.4 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 14 (n=251,252)	97.2 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 18C (n=252,252)	98.4 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 19F (n=252,251)	97.6 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Common Serotypes - Serotype 23F (n=252,252)	94.0 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 1 (n=252,248)	1.6 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 3 (n=249,241)	4.6 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 5 (n=252,197)	31.0 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 6A (n=252,240)	42.5 percentage of participants
7vPnC	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	Additional Serotypes - Serotype 7F (n=252,248)	2.8 percentage of participants

Comparison: For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-7.3, -0.1]

Comparison: For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-10.9, -0.1]

Comparison: For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-12.4, -4]

Comparison: For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.7, 3.5]

Comparison: For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-4.7, 1.2]

Comparison: For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-2.4, 3.4]

Comparison: For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated95% CI: [-8.5, 1.2]

Primary

Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series

Predefined Antibody Levels for Haemophilus Influenzae Type b (\[Hib\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \[IU\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \[FHA\] 40.5 Elisa Units \[EU\]/mL, Pertussis toxoid \[PT\] 16.5 EU/mL, Pertussis pertactin \[PRN\] 26 EU/mL).

Time frame: One Month After the Infant Series (7 months of age)

Population: Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.

Arm	Measure	Group	Value (NUMBER)
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Hib 0.15 µg/mL (n=237,230)	97.9 Percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Hib 1.0 µg/mL (n=237,230)	77.6 Percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Diphtheria [IU]/mL (n=233,230)	95.7 Percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	FHA [EU]/mL (n=239,240)	96.7 Percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	PT [EU]/mL (n=239,240)	94.1 Percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	PRN [EU]/mL (n=239,240)	93.7 Percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	PT [EU]/mL (n=239,240)	95.0 Percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Hib 0.15 µg/mL (n=237,230)	97.8 Percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	FHA [EU]/mL (n=239,240)	95.0 Percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Hib 1.0 µg/mL (n=237,230)	78.3 Percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	PRN [EU]/mL (n=239,240)	95.8 Percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	Diphtheria [IU]/mL (n=233,230)	96.1 Percentage of participants

Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.95% CI: [-2.9, 3.1]

Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.95% CI: [-8.3, 7]

Comparison: For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.95% CI: [-4.3, 3.5]

Comparison: For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.95% CI: [-2.1, 5.6]

Comparison: For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.95% CI: [-5.2, 3.4]

Comparison: For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.95% CI: [-6.4, 2]

Primary

Percentage of Participants Reporting Pre-specified Local Reactions

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\[Sig.\], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (\[Mod.\], 2.5 to 7.0 cm); Severe (\[Sev.\], \> 7.0 cm). Participants may have been represented in more than 1 category.

Time frame: Within 7 days after each dose

Population: Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.

Arm	Measure	Group	Value (NUMBER)
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	6.8 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	23.1 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	4.5 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	13.7 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	72.7 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	34.5 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	35.6 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	27.4 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	72.2 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	21.2 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	5.2 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	32.3 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	2.6 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	23.6 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	31.4 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	9.2 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	10.6 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	77.0 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	31.2 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	29.8 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	5.1 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	45.2 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	44.5 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	1.7 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	7.1 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	3.2 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	37.8 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	26.1 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	75.9 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	37.0 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	29.5 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	11.5 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	8.8 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	48.9 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	6.6 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	35.4 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	78.7 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	5.5 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	37.9 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	47.7 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	36.9 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	6.1 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	9.3 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	50.0 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	48.7 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	80.9 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	5.0 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	36.9 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	14.7 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	53.9 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	81.2 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	15.4 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	8.1 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	44.0 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	54.4 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	43.3 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Sev. (n=172,187,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mod. (n=177,191,117,124,91,80,62,50)	14.0 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mod. (n=176,193,118,126,91,82,68,49)	14.3 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Mild (n=200,220,155,162,128,117,102,85)	63.5 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Any (n=201,216,141,146,116,103,91,73)	50.7 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Sev. (n=173,186,116,120,87,79,59,44)	0.0 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Any (n=264,270,200,216,178,173,149,147)	84.4 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Redness-Any (n=202,223,155,164,131,118,103,87)	65.5 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Tenderness-Sig. (n=182,195,123,131,91,86,65,49)	12.2 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Local Reactions	Swelling-Mild (n=199,212,141,142,113,103,90,71)	46.5 Percentage of participants

Primary

Percentage of Participants Reporting Pre-specified Systemic Events

Systemic events (any fever \[Fv\] ≥ 38 degrees Celsius \[C\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \[urticaria\], use of antipyretic medication \[med\] to treat or prevent symptoms \[sx\]) were reported using an electronic diary. Participants may be represented in more than 1 category.

Time frame: Within 7 days after each dose

Population: Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.

Arm	Measure	Group	Value (NUMBER)
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	89.6 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	54.8 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	75.0 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	78.6 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	2.8 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	24.0 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	1.7 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	45.7 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	79.5 Percentage of participants
13vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	0.0 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	21.2 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	45.4 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	85.9 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	74.8 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	47.9 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	71.8 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	0.0 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	1.1 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	78.5 Percentage of participants
7vPnC	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	0.0 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	2.5 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	43.2 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	0.0 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	59.9 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	89.8 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	79.3 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	49.1 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	2.5 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	82.4 Percentage of participants
13vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	86.7 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	91.5 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	81.9 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	83.5 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	73.5 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	55.8 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	52.3 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	40.4 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	0.0 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	0.8 Percentage of participants
7vPnC Dose 2	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	4.9 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	8.5 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	60.4 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	88.4 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	59.2 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	39.8 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	82.3 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	71.3 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	0.0 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	4.5 Percentage of participants
13vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	81.2 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	59.6 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	92.2 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	69.8 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	2.5 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	63.4 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	84.1 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	0.0 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	37.7 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	85.6 Percentage of participants
7vPnC Dose 3	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	1.3 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	70.4 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	92.0 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	4.8 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	53.5 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	88.4 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	6.6 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	84.0 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	1.7 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	58.4 Percentage of participants
13vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	65.5 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Incr. sleep (n=268,270,203,200,164,149,115,109)	74.3 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Med-treat sx (n=257,266,221,221,203,187,162,138)	87.7 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Irritability (n=289,290,236,236,216,218,199,175)	93.1 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Hives (urticaria) (n=178,188,118,120,89,79,62,47)	6.4 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Fv >40°C (n=174,187,116,121,87,80,60,45)	0.0 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Med-prevent sx (n=272,274,233,231,202,189,164,162)	90.7 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	51.3 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. sleep (n=221,236,169,172,154,134,113,95)	64.2 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	12.5 Percentage of participants
7vPnC Toddler Dose	Percentage of Participants Reporting Pre-specified Systemic Events	Decr. appetite (n=228,238,177,174,147,136,116,110)	73.6 Percentage of participants

Secondary

Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Time frame: one month after the toddler dose

Population: The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.

Arm	Measure	Value (GEOMETRIC_MEAN)
13vPnC	Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	6.84 µg/mL
7vPnC	Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	7.30 µg/mL

Comparison: For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.75, 1.17]

Secondary

Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Normalization was performed for unit of measure index value as Index Value of 1.00 = 10 mIU/mL.

Time frame: one month after the toddler dose

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Measles	1.98 index value
13vPnC	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Mumps	1.32 index value
13vPnC	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Varicella	0.74 index value
7vPnC	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Measles	2.06 index value
7vPnC	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Mumps	1.32 index value
7vPnC	Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	Varicella	0.73 index value

Comparison: For Measles the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.85, 1.08]

Comparison: For Mumps the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.87, 1.14]

Comparison: For Varicella the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.92, 1.1]

Secondary

Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Time frame: one month after the toddler dose

Arm	Measure	Value (GEOMETRIC_MEAN)
13vPnC	Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	76.53 IU/mL
7vPnC	Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	97.69 IU/mL

Comparison: For Rubella the GMC ratio (13vPnC/7vPnC) was calculated95% CI: [0.62, 1]

Secondary

Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose

Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Time frame: one month after the infant series and the toddler dose

Population: Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes -Serotype 4 (n=92,92,88,92)	359.32 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	1054.65 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	4035.40 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	1240.41 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	275.59 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	54.42 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	791.07 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	51.83 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	120.67 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	90.86 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	979.68 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	9493.77 titer
13vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	151.94 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	1480.55 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	6.53 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	100.35 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	4.41 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	3259.01 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes -Serotype 4 (n=92,92,88,92)	535.68 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	4.15 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	6.70 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	44.92 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	375.64 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	1513.66 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	128.00 titer
7vPnC	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	923.56 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	2241.79 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	2002.23 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	993.27 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	1024.00 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	199.65 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	2723.25 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	11629.44 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	164.23 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	380.41 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	300.41 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes -Serotype 4 (n=92,92,88,92)	1179.98 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	3099.51 titer
13vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	11856.03 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	4.69 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	5.01 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	2365.87 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes -Serotype 4 (n=92,92,88,92)	1492.46 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	4981.68 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	167.20 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	18032.33 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	4066.22 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	1722.16 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	11.81 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	28.65 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	267.84 titer
7vPnC Dose 2	Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	538.54 titer

Secondary

Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose

Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Time frame: One month after infant series and one month after toddler dose

Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.

Arm	Measure	Group	Value (NUMBER)
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 4 (n=92,92,88,92)	97.8 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	98.9 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	100.0 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	100.0 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	100.0 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	90.4 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	98.9 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	98.9 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	96.8 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	92.3 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	100.0 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	100.0 percentage of participants
13vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	91.4 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	100.0 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	16.3 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	77.7 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	9.8 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	98.9 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 4 (n=92,92,88,92)	98.9 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	2.2 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	21.3 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	92.6 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	100.0 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	100.0 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	76.4 percentage of participants
7vPnC	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	100.0 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	97.8 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	96.7 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	100.0 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	97.8 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 4 (n=92,92,88,92)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	98.9 percentage of participants
13vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	98.9 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 5 (n=91,93,91,96)	5.2 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 1 (n=92,92,89,92)	12.0 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 14 (n=94,94,92,96)	100.0 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 4 (n=92,92,88,92)	98.9 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 23F (n=94,94,90,92)	100.0 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 19F (n=94,94,92,96)	94.8 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 9V (n=93,94,90,94)	100.0 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 6B (n=94,94,92,95)	100.0 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Common Serotypes - Serotype 18C (n=94,94,91,96)	100.0 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 3 (n=94,94,91,96)	43.8 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes-Serotype 19A (n=93,92,91,94)	53.2 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 7F (n=94,89,91,92)	80.4 percentage of participants
7vPnC Dose 2	Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	Additional Serotypes - Serotype 6A (n=94,94,92,96)	94.8 percentage of participants

Secondary

Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)

Time frame: One month after toddler dose (13 to 16 months of age)

Population: Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.

Arm	Measure	Group	Value (NUMBER)
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Measles ≥1.10 I.V. (n=221,210)	96.4 percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Rubella ≥15 IU/mL (n=209,204)	91.9 percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Hib (PRP) 0.15 µg/mL (n=230,214)	100.0 percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Mumps ≥1.10 I.V. (n=221,210)	76.5 percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Hib (PRP) 1.0 µg/mL (n=230,214)	90.4 percentage of participants
13vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Varicella ≥1.09 I.V. (n=221,210)	26.7 percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Hib (PRP) 1.0 µg/mL (n=230,214)	92.1 percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Varicella ≥1.09 I.V. (n=221,210)	21.9 percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Measles ≥1.10 I.V. (n=221,210)	97.1 percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Mumps ≥1.10 I.V. (n=221,210)	72.9 percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Rubella ≥15 IU/mL (n=209,204)	90.7 percentage of participants
7vPnC	Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	Hib (PRP) 0.15 µg/mL (n=230,214)	100.0 percentage of participants

Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.95% CI: [-1.6, 1.7]

Comparison: For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.95% CI: [-7.1, 3.8]

Comparison: For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.95% CI: [-4.5, 2.9]

Comparison: For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.95% CI: [-4.7, 11.9]

Comparison: For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.95% CI: [-4.4, 6.9]

Comparison: For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.95% CI: [-3.4, 13]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series

Percentage of Participants Reporting Pre-specified Local Reactions

Percentage of Participants Reporting Pre-specified Systemic Events

Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose

Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose

Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)