Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00366678

Collaborator

(none)

613

Enrollment

Locations

Arms

Duration (Months)

13.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

Condition or Disease	Intervention/Treatment	Phase
Vaccines, Pneumococcal	Biological: 13-valent pneumococcal conjugate vaccine Biological: 7-valent pneumococcal conjugate vaccine Drug: Pentavac	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

613 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine	Biological: 13-valent pneumococcal conjugate vaccine Single 0.5 mL dose given at 2, 3, 4, and 12 months of age. Drug: Pentavac The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Active Comparator: 7-valent pneumococcal conjugate vaccine 7-valent pneumococcal conjugate vaccine	Biological: 7-valent pneumococcal conjugate vaccine Single 0.5 mL dose given at 2, 3, 4, and 12 months of age. Drug: Pentavac The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

Arm

Intervention/Treatment

Experimental: 13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.

Drug: Pentavac

The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

Active Comparator: 7-valent pneumococcal conjugate vaccine

7-valent pneumococcal conjugate vaccine

Biological: 7-valent pneumococcal conjugate vaccine

Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.

Drug: Pentavac

The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group [One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group [One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group [One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group [One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group [One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)]
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC [One month after the 3-Dose Infant Series (at 5 months of age)]
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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.
Percentage of Participants Reporting Pre-Specified Local Reactions [During the 4-day period after each dose]
Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events [During the 4-day period after each dose]
Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC [One month after the 3-Dose Infant Series (at 5 months of age)]
Antibody GMC 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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.

Secondary Outcome Measures

Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups [One month after the toddler dose (at 13 months of age)]
Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/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.
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups [One month after the Toddler Dose (at 13 months of age)]
Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups [One month after the toddler dose (at 13 months of age)]
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose [One month after the toddler dose (at 13 months of age)]
GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

42 Days to 98 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion criteria:

· Known contraindication to vaccines.

Contacts and Locations

Locations

	City	Country	Postal Code
1	Albi	France	81000
2	Amiens	France	80000
3	Ancenis	France	44150
4	Blanquefort	France	33370
5	Bondues	France	59910
6	Bordeaux	France	33000
7	Brest	France	29200
8	Chalons en champagne	France	51000
9	Creteil	France	94000
10	Dijon	France	21000
11	Draguignan	France	83300
12	Ecully	France	69130
13	Essey-les-nancy	France	54270
14	Floirac	France	33270
15	Frejus	France	83600
16	Garges-les-Gonesse	France	95140
17	Illkirch	France	67400
18	Joue les tours	France	37300
19	Le havre	France	76600
20	Le plessis-trevise	France	94420
21	Le pontet	France	84130
22	Les lilas	France	93260
23	Les sables d'olonne	France	85100
24	Libourne	France	33500
25	Lingolsheim	France	67380
26	Lyon	France	69005
27	Lyon	France	69007
28	Marcq en baroeul	France	59700
29	Maromme	France	76150
30	Moutiers	France	73600
31	Nancy	France	54000
32	Nice	France	06300
33	Nogent sur marne	France	94130
34	Nogent-sur-marne	France	94130
35	Oullins	France	69600
36	Paris	France	75571
37	Rouen	France	76100
38	Strasbourg	France	67000
39	Strasbourg	France	67100
40	Thionville	France	57100
41	Tours	France	37000
42	Tresses melac	France	33370
43	Vandoeuvre les nancy	France	54500
44	Vaulx-en-velin	France	69120
45	Villeneuve d'ascq	France	59650
46	Vitry-sur-seine	France	94400

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager, For France, infomedfrance@wyeth.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00366678

Other Study ID Numbers:

6096A1-008

First Posted:

Aug 21, 2006

Last Update Posted:

Aug 15, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer

Safety

Vaccine

Additional relevant MeSH terms:

Vaccines

Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details	Participants were recruited in France from October 2006 to July 2007.
Pre-assignment Detail	Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.

Arm/Group Title	13vPnC/13vPnC Vaccine	7vPnC/7vPnC Vaccine	7vPnC/13vPnC Vaccine
Arm/Group Description	Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
Period Title: Infant Series
STARTED	304	309	0
Vaccinated Dose 1	302	309	0
Vaccinated Dose 2	295	304	0
Vaccinated Dose 3	291	302	0
COMPLETED	290	299	0
NOT COMPLETED	14	10	0
Period Title: Infant Series
STARTED	290	299	0
COMPLETED	273	289	0
NOT COMPLETED	17	10	0
Period Title: Infant Series
STARTED	273	152	137
COMPLETED	268	151	137
NOT COMPLETED	5	1	0

Baseline Characteristics

Arm/Group Title	13vPnC/13vPnC Vaccine	7vPnC/7vPnC Vaccine	Total
Arm/Group Description	Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Total of all reporting groups
Overall Participants	304	309	613
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	2.1 (0.5)	2.1 (0.5)	2.1 (0.5)
Sex: Female, Male (Count of Participants)
Female	169 55.6%	164 53.1%	333 54.3%
Male	135 44.4%	145 46.9%	280 45.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Description	Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
Time Frame	One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC After the Toddler Dose	7vPnC After the Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Measure Participants	266	263	241	133
Pertussis - PT Infant ≥5 Toddler 5 (EU/mL)	100.0 32.9%	100.0 32.4%	100.0 16.3%	100.0 NaN
Pertussis - PT Infant ≥26 Toddler 17 (EU/mL)	94.3 31%	95.0 30.7%	98.3 16%	96.2 NaN
Pertussis - FHA Infant ≥5 Toddler 5 (EU/mL)	100.0 32.9%	100.0 32.4%	100.0 16.3%	100.0 NaN
Pertussis - FHA Infant ≥7.82 Toddler 7.82 (EU/mL)	100.0 32.9%	100.0 32.4%	100.0 16.3%	100.0 NaN
Pertussis - FHA Infant ≥36.00 Toddler 75 (EU/mL)	93.5 30.8%	95.8 31%	92.5 15.1%	95.5 NaN
Diphtheria 0.1 (IU/mL)	76.5 25.2%	84.6 27.4%	99.2 16.2%	100 NaN
Diphtheria 0.01 (IU/mL)	100.0 32.9%	100.0 32.4%	100.0 16.3%	100.0 NaN
Tetanus 0.1 (IU/mL)	84.9 27.9%	82.2 26.6%	96.2 15.7%	98.5 NaN
Tetanus 0.01 (IU/mL)	100.0 32.9%	100.0 32.4%	100.0 16.3%	100.0 NaN
Polio Type 1 (1:8)	88.8 29.2%	91.0 29.4%	97.9 16%	98.4 NaN
Polio Type 2 (1:8)	77.7 25.6%	82.0 26.5%	98.7 16.1%	99.2 NaN
Polio Type 3 (1:8)	92.6 30.5%	93.0 30.1%	99.2 16.2%	100.0 NaN
Hib (PRP) 0.15 (μg/mL)	95.5 31.4%	94.6 30.6%	100.0 16.3%	100.0 NaN
Hib (PRP) 1.0 (μg/mL)	58.6 19.3%	63.1 20.4%	97.9 16%	97.7 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.4 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.7
	Confidence Interval	() 95% -4.8 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.4 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-2.3
	Confidence Interval	() 95% -6.4 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.4 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	2.1
	Confidence Interval	() 95% -1.4 to 6.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-3.0
	Confidence Interval	() 95% -8.0 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-8.0
	Confidence Interval	() 95% -14.9 to -1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.4 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	2.7
	Confidence Interval	() 95% -3.7 to 9.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.5 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.8
	Confidence Interval	() 95% -3.1 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-2.3
	Confidence Interval	() 95% -5.8 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-2.3
	Confidence Interval	() 95% -7.6 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-4.3
	Confidence Interval	() 95% -11.4 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.3
	Confidence Interval	() 95% -5.0 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.5
	Confidence Interval	() 95% -3.6 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.5
	Confidence Interval	() 95% -3.1 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.8
	Confidence Interval	() 95% -3.1 to 1.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.9
	Confidence Interval	() 95% -3.2 to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-4.5
	Confidence Interval	() 95% -13.2 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.2
	Confidence Interval	() 95% -3.1 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Description	Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/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 toddler dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
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 antibody concentration for the specified serotype.

Arm/Group Title	13vPnC Infant Series / 13vPnC Toddler Dose	7vPnC Infant Series / 7vPnC Toddler Dose	7vPnC Infant Series / 13vPnC Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
Measure Participants	241	133	121
Common Serotypes - Serotype 4 (n=233,126,111)	100.0 32.9%	100.0 32.4%	99.1 16.2%
Common Serotypes - Serotype 6B (n=233,126,108)	99.6 32.8%	99.2 32.1%	98.1 16%
Common Serotypes - Serotype 9V (n=232,124,109)	100.0 32.9%	100.0 32.4%	100.0 16.3%
Common Serotypes - Serotype 14 (n=233,135,111)	99.6 32.8%	100.0 32.4%	99.1 16.2%
Common Serotypes - Serotype 18C (n=230,125,113)	99.6 32.8%	99.2 32.1%	98.2 16%
Common Serotypes - Serotype 19F (n=233,126,112)	97.9 32.2%	97.6 31.6%	97.3 15.9%
Common Serotypes - Serotype 23F (n=232,123,111)	99.6 32.8%	99.2 32.1%	99.1 16.2%
Additional Serotypes - Serotype 1 (n=233,119,112)	100.0 32.9%	0.8 0.3%	95.5 15.6%
Additional Serotypes - Serotype 3 (n=233,124,113)	94.8 31.2%	13.7 4.4%	93.8 15.3%
Additional Serotypes - Serotype 5 (n=236,111,111)	100.0 32.9%	73.0 23.6%	90.1 14.7%
Additional Serotypes - Serotype 6A (n=235,124,109)	100.0 32.9%	89.5 29%	89.9 14.7%
Additional Serotypes - Serotype 7F (n=234,124,110)	100.0 32.9%	7.3 2.4%	100.0 16.3%
Additional Serotypes - Serotype 19A(n=233,127,112)	100.0 32.9%	100.0 32.4%	100.0 16.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.9
	Confidence Interval	() 95% -0.9 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.9
	Confidence Interval	() 95% -4.9 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.4
	Confidence Interval	() 95% -1.8 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	1.4
	Confidence Interval	() 95% -1.1 to 5.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-1.1
	Confidence Interval	() 95% -5.8 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.7 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -1.8 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	() 95% -3.3 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.4
	Confidence Interval	() 95% -2.5 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.5
	Confidence Interval	() 95% -1.8 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.9
	Confidence Interval	() 95% -4.9 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.4
	Confidence Interval	() 95% -1.8 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	1.3
	Confidence Interval	() 95% -1.1 to 5.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-1.0
	Confidence Interval	() 95% -5.5 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.2
	Confidence Interval	() 95% -3.1 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.5
	Confidence Interval	() 95% -2.9 to 5.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.3
	Confidence Interval	() 95% -5.5 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.4
	Confidence Interval	() 95% -1.8 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.5
	Confidence Interval	() 95% -1.9 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 13vPnC After the Toddler Dose
	Comments	For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.1
	Confidence Interval	() 95% -4.1 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Description	Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	One month after the Toddler Dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC/13vPnC Before Toddler Dose	13vPnC/13vPnC After Toddler Dose	7vPnC/7vPnC Before Toddler Dose	7vPnC/7vPnC After Toddler Dose	7vPnC/13vPnC Before Toddler Dose	7vPnC/13vPnC After Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.	Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
Measure Participants	241	241	133	133	121	121
Common - Serotype 4 (n=239,233,131,126,118,111)	0.3	4.2	0.5	4.8	0.5	4.0
Common - Serotype 6B (n=235,233,131,126,115,108)	1.0	9.0	1.1	9.6	0.9	10.3
Common - Serotype 9V (n=239,232,131,124,118,109)	0.4	2.3	0.5	3.2	0.4	2.3
Common - Serotype 14 (n=238,233,131,125,118,111)	2.0	9.5	2.4	10.8	2.4	7.8
Common - Serotype 18C (n=239,230,131,125,118,113)	0.3	2.3	0.3	2.8	0.3	2.4
Common - Serotype 19F (n=239,233,130,126,118,112)	0.7	5.2	0.7	4.1	0.6	3.7
Common - Serotype 23F (n=237,232,130,123,118,111)	0.3	3.0	0.3	3.7	0.3	3.1
Additional-Serotype 1 (n=239,233,128,119,116,112)	0.4	4.1	0.0	0.0	0.0	1.8
Additional-Serotype 3 (n=232,233,128,124,115,113)	0.2	1.0	0.1	0.1	0.1	1.3
Additional-Serotype 5 (n=236,236,128,124,115,113)	0.8	3.3	0.4	0.5	0.4	1.1
Additional-Serotype 6A (n=238,235,122,124,116,109)	0.9	6.1	0.4	1.5	0.4	2.6
Additional-Serotype 7F (n=239,234,131,124,117,110)	0.8	4.5	0.1	0.1	0.1	3.7
Additional-Serotype 19A(n=237,233,131,127,117,112)	1.5	9.5	1.1	4.0	0.9	5.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.87
	Confidence Interval	() 95% 0.73 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.83
	Confidence Interval	() 95% 0.67 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.04
	Confidence Interval	() 95% 0.86 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.93
	Confidence Interval	() 95% 0.77 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.07
	Confidence Interval	() 95% 0.82 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.87
	Confidence Interval	() 95% 0.69 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.80
	Confidence Interval	() 95% 0.68 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.71
	Confidence Interval	() 95% 0.59 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.13
	Confidence Interval	() 95% 0.95 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.88
	Confidence Interval	() 95% 0.73 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.72
	Confidence Interval	() 95% 0.58 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.22
	Confidence Interval	() 95% 1.00 to 1.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.82
	Confidence Interval	() 95% 0.69 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.86
	Confidence Interval	() 95% 0.69 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.95
	Confidence Interval	() 95% 0.78 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.26
	Confidence Interval	() 95% 1.00 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.91
	Confidence Interval	() 95% 0.68 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.39
	Confidence Interval	() 95% 1.08 to 1.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC After the Toddler Dose
	Comments	For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.81
	Confidence Interval	() 95% 0.67 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Toddler Dose, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.85
	Confidence Interval	() 95% 0.67 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	7vPnC After the Infant Series, 7vPnC/13vPnC After Toddler Dose
	Comments	For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.96
	Confidence Interval	() 95% 0.78 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Description	Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	One month after the toddler dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC/13vPnC After Toddler Dose	7vPnC/13vPnC After Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
Measure Participants	241	121
Additional Serotypes - Serotype 1	100.0 32.9%	98.9 32%
Additional Serotypes - Serotype 3	100.0 32.9%	97.8 31.7%
Additional Serotypes - Serotype 5	100.0 32.9%	97.8 31.7%
Additional Serotypes - Serotype 6A	100.0 32.9%	98.9 32%
Additional Serotypes - Serotype 7F	100.0 32.9%	100.0 32.4%
Additional Serotypes - Serotype 19A	98.8 32.5%	97.8 31.7%

5. Secondary Outcome

Title	Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
Description	GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	One month after the toddler dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC/13vPnC After Toddler Dose	7vPnC/13vPnC After Toddler Dose
Arm/Group Description	Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.	Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
Measure Participants	241	121
Additional Serotypes - Serotype 1	126.00	61.58
Additional Serotypes - Serotype 3	345.33	428.88
Additional Serotypes - Serotype 5	244.18	130.99
Additional Serotypes - Serotype 6A	1346.83	891.44
Additional Serotypes - Serotype 7F	8126.24	17034.59
Additional Serotypes - Serotype 19A	804.06	1072.43

6. Primary Outcome

Title	Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
Description
Time Frame	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC After the Toddler Dose	7vPnC After the Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
Measure Participants	266	263	241	133
Diphtheria	0.19	0.24	2.09	2.60
Tetanus	0.20	0.21	1.08	1.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Diphtheria the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.77
	Confidence Interval	() 95% 0.66 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Tetanus the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.94
	Confidence Interval	() 95% 0.82 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Diphtheria the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.80
	Confidence Interval	() 95% 0.67 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Tetanus the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.86
	Confidence Interval	() 95% 0.69 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
Description
Time Frame	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC After the Toddler Dose	7vPnC After the Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Measure Participants	244	241	240	132
Number (95% Confidence Interval) [μg/mL]	1.28	1.40	12.15	11.68

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Hib (PRP) the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.91
	Confidence Interval	() 95% 0.73 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Hib (PRP) the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.04
	Confidence Interval	() 95% 0.82 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Description
Time Frame	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC After the Toddler Dose	7vPnC After the Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Measure Participants	258	256	239	129
Polio Type 1	24.99	28.33	253.05	250.56
Polio Type 2	17.75	21.55	408.34	415.20
Polio Type 3	41.08	52.95	536.32	638.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Polio Type 1 the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.88
	Confidence Interval	() 95% 0.71 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Polio Type 2 the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.82
	Confidence Interval	() 95% 0.66 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Polio Type 3 the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.78
	Confidence Interval	() 95% 0.59 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Polio Type 1 the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.01
	Confidence Interval	() 95% 0.72 to 1.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Polio Type 2 the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.98
	Confidence Interval	() 95% 0.72 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Polio Type 3 the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.84
	Confidence Interval	() 95% 0.60 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Primary Outcome

Title	Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Description
Time Frame	One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Arm/Group Title	13vPnC After the Infant Series	7vPnC After the Infant Series	13vPnC After the Toddler Dose	7vPnC After the Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Measure Participants	263	262	239	133
Pertussis - FHA	97.12	111.23	204.28	241.08
Pertussis - PT	62.94	68.20	61.09	61.70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - FHA the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.87
	Confidence Interval	() 95% 0.78 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Infant Series, 7vPnC After the Infant Series
	Comments	For Pertussis - PT the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.92
	Confidence Interval	() 95% 0.84 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - FHA the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.85
	Confidence Interval	() 95% 0.72 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC After the Toddler Dose, 7vPnC After the Toddler Dose
	Comments	For Pertussis - PT the GMC ratio was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.99
	Confidence Interval	() 95% 0.86 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Primary Outcome

Title	Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Description	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 (at 5 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population 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 immunoglobulin G (IgG) antibody concentration to the given serotype.

Arm/Group Title	13vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
Measure Participants	266
Common Serotypes - Serotype 4 (n=244)	91.4 30.1%
Common Serotypes - Serotype 6B (n=241)	72.6 23.9%
Common Serotypes - Serotype 9V (n=238)	92.9 30.6%
Common Serotypes - Serotype 14 (n=236)	94.9 31.2%
Common Serotypes - Serotype 18C (n=242)	90.5 29.8%
Common Serotypes - Serotype 19F (n=241)	97.9 32.2%
Common Serotypes - Serotype 23F (n=244)	82.8 27.2%
Additional Serotypes - Serotype 1 (n=240)	90.8 29.9%
Additional Serotypes - Serotype 3 (n=242)	96.3 31.7%
Additional Serotypes - Serotype 5 (n=243)	84.0 27.6%
Additional Serotypes - Serotype 6A (n=243)	85.6 28.2%
Additional Serotypes - Serotype 7F (n=238)	97.5 32.1%
Additional Serotypes - Serotype 19A (n=244)	97.5 32.1%

11. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions
Description	Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
Time Frame	During the 4-day period after each dose

Outcome Measure Data

Analysis Population Description
The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.

Arm/Group Title	13vPnC Dose 1	7vPnC Dose 1	13vPnC Dose 2	7vPnC Dose 2	13vPnC Dose 3	7vPnC Dose 3	13vPnC/13vPnC Toddler Dose	7vPnC/7vPnC Toddler Dose	7vPnC/13vPnC Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
Measure Participants	302	309	302	309	302	309	273	152	137
Tender-Any (n=256,257,223,225,210,206,189,96,89)	38.3 12.6%	38.5 12.5%	33.2 5.4%	42.2 NaN	36.2 NaN	32.0 NaN	50.3 NaN	44.8 NaN	64.0 NaN
Tender-Sig (n=237,245,203,208,188,193,155,86,75)	5.5 1.8%	4.9 1.6%	5.4 0.9%	6.7 NaN	3.7 NaN	3.1 NaN	5.2 NaN	4.7 NaN	8.0 NaN
Swelling-Any (n=254,256,226,235,217,219,185,99,97)	41.3 13.6%	38.7 12.5%	50.0 8.2%	54.5 NaN	48.4 NaN	51.1 NaN	53.5 NaN	57.6 NaN	59.8 NaN
Swelling-Mild(n=249,255,223,232,213,214,181,99,95)	36.9 12.1%	35.7 11.6%	46.6 7.6%	51.3 NaN	44.6 NaN	45.8 NaN	48.1 NaN	55.6 NaN	57.9 NaN
Swelling-Mod (n=243,246,207,208,193,194,159,88,82)	14.4 4.7%	9.3 3%	14.0 2.3%	14.4 NaN	14.0 NaN	16.0 NaN	19.5 NaN	15.9 NaN	20.7 NaN
Swelling-Sev (n=235,244,199,203,184,188,152,87,73)	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.7 NaN	0.0 NaN	0.0 NaN
Redness-Any (n=256,260,236,241,226,223,187,106,99)	44.5 14.6%	46.9 15.2%	53.4 8.7%	58.1 NaN	55.8 NaN	59.2 NaN	66.8 NaN	60.4 NaN	63.6 NaN
Redness-Mild(n=252,259,234,240,223,221,180,106,95)	40.9 13.5%	45.6 14.8%	50.9 8.3%	56.7 NaN	52.5 NaN	55.7 NaN	60.0 NaN	54.7 NaN	60.0 NaN
Redness-Mod (n=241,245,205,206,190,192,165,87,79)	9.5 3.1%	3.7 1.2%	7.3 1.2%	6.8 NaN	8.9 NaN	12.5 NaN	24.2 NaN	18.4 NaN	20.3 NaN
Redness-Sev (n=234,244,199,203,184,188,152,86,73)	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.7 NaN	0.0 NaN	0.0 NaN

12. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events
Description	Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	During the 4-day period after each dose

Outcome Measure Data

Analysis Population Description
The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.

Arm/Group Title	13vPnC Dose 1	7vPnC Dose 1	13vPnC Dose 2	7vPnC Dose 2	13vPnC Dose 3	7vPnC Dose 3	13vPnC/13vPnC Toddler Dose	7vPnC/7vPnC Toddler Dose	7vPnC/13vPnC Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
Measure Participants	302	309	302	309	302	309	273	152	137
Fv≥38°C,≤39°C(n=244,250,212,217,201,208,174,99,83)	13.5 4.4%	10.0 3.2%	19.8 3.2%	25.3 NaN	26.9 NaN	27.9 NaN	36.8 NaN	41.4 NaN	42.2 NaN
Fv>39°C,≤40°C(n=238,245,201,205,184,191,153,89,73)	0.8 0.3%	0.4 0.1%	1.0 0.2%	2.4 NaN	0.5 NaN	1.6 NaN	4.6 NaN	2.2 NaN	4.1 NaN
Fv >40°C (n=238,245,200,205,184,190,153,88,73)	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.5 NaN	0.0 NaN	0.7 NaN	0.0 NaN	0.0 NaN
Decr appetite(n=243,251,211,218,194,199,167,96,83)	24.7 8.1%	23.1 7.5%	18.5 3%	26.1 NaN	23.2 NaN	21.1 NaN	29.3 NaN	34.4 NaN	31.3 NaN
Irritability (n=261,265,232,238,217,211,178,99,91)	54.4 17.9%	52.5 17%	48.3 7.9%	49.6 NaN	41.9 NaN	40.3 NaN	50.6 NaN	46.5 NaN	50.5 NaN
Incr sleep (n=256,259,215,227,194,204,163,92,81)	34.0 11.2%	41.3 13.4%	28.4 4.6%	32.2 NaN	23.7 NaN	28.4 NaN	21.5 NaN	23.9 NaN	23.5 NaN
Decr sleep (n=246,253,,215,218,203,196,168,93,81)	28.0 9.2%	20.6 6.7%	26.5 4.3%	27.1 NaN	25.1 NaN	20.9 NaN	26.2 NaN	22.6 NaN	30.9 NaN
Med-treat sx(n=248,259,224,227,202,214,180,100,89)	29.0 9.5%	32.8 10.6%	38.4 6.3%	44.5 NaN	36.1 NaN	42.1 NaN	47.8 NaN	54.0 NaN	55.1 NaN
Med-prevent sx(n=252,260,221,236,201,213,181,99,85	34.5 11.3%	34.6 11.2%	36.7 6%	40.3 NaN	28.4 NaN	37.6 NaN	38.7 NaN	44.4 NaN	40.0 NaN

13. Primary Outcome

Title	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
Description	Antibody GMC 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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
Time Frame	One month after the 3-Dose Infant Series (at 5 months of age)

Outcome Measure Data

Analysis Population Description
The evaluable immunogenicity (per protocol) population was the primary analysis population consisting 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 concentration for the specified serotype.

Arm/Group Title	13vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
Measure Participants	266
Common Serotypes - Serotype 4 (n=244)	1.29
Common Serotypes - Serotype 6B (n=241)	0.74
Common Serotypes - Serotype 9V (n=238)	1.15
Common Serotypes - Serotype 14 (n=236)	2.74
Common Serotypes - Serotype 18C (n=242)	1.42
Common Serotypes - Serotype 19F (n=241)	1.55
Common Serotypes - Serotype 23F (n=244)	0.92
Additional Serotypes - Serotype 1 (n=240)	1.21
Additional Serotypes - Serotype 3 (n=242)	1.25
Additional Serotypes - Serotype 5 (n=243)	0.93
Additional Serotypes - Serotype 6A (n=243)	0.94
Additional Serotypes - Serotype 7F (n=238)	1.93
Additional Serotypes - Serotype 19A (n=244)	2.10

Adverse Events

	13vPnC Infant Series		7vPnC Infant Series		13vPnC Post-Infant Series		7vPnC Post-Infant Series		13vPnC/13vPnC Toddler Dose		7vPnC/7vPnC Toddler Dose		7vPnC/ 13vPnC Toddler Dose		13vPnC / 13vPnC 6-Month Follow-up		7vPnC / 7vPnC 6-Month Follow-up		7vPnC / 13vPnC 6-Month Follow-up
Time Frame
Adverse Event Reporting Description

Arm/Group Title	13vPnC Infant Series		7vPnC Infant Series		13vPnC Post-Infant Series		7vPnC Post-Infant Series		13vPnC/13vPnC Toddler Dose		7vPnC/7vPnC Toddler Dose		7vPnC/ 13vPnC Toddler Dose		13vPnC / 13vPnC 6-Month Follow-up		7vPnC / 7vPnC 6-Month Follow-up		7vPnC / 13vPnC 6-Month Follow-up
Arm/Group Description	Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.		Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.		Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.		Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.		Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.		Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.		Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.		Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.		Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.		Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	13vPnC Infant Series		7vPnC Infant Series		13vPnC Post-Infant Series		7vPnC Post-Infant Series		13vPnC/13vPnC Toddler Dose		7vPnC/7vPnC Toddler Dose		7vPnC/ 13vPnC Toddler Dose		13vPnC / 13vPnC 6-Month Follow-up		7vPnC / 7vPnC 6-Month Follow-up		7vPnC / 13vPnC 6-Month Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/304 (1.6%)		5/309 (1.6%)		8/290 (2.8%)		5/299 (1.7%)		2/273 (0.7%)		0/152 (0%)		2/134 (1.5%)		6/267 (2.2%)		1/150 (0.7%)		0/133 (0%)
Blood and lymphatic system disorders
Haemolytic anaemia	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
General disorders
Pyrexia	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		1/273 (0.4%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Immune system disorders
Anaphylactic reaction	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Infections and infestations
Bronchiolitis	2/304 (0.7%)		1/309 (0.3%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		1/134 (0.7%)		0/267 (0%)		1/150 (0.7%)		0/133 (0%)
Bronchitis	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Bronchopneumonia	0/304 (0%)		0/309 (0%)		0/290 (0%)		1/299 (0.3%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Ear infection	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		1/299 (0.3%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Gastroenteritis	1/304 (0.3%)		1/309 (0.3%)		2/290 (0.7%)		1/299 (0.3%)		0/273 (0%)		0/152 (0%)		1/134 (0.7%)		2/267 (0.7%)		0/150 (0%)		0/133 (0%)
Gastroenteritis bacterial	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/273 (0.4%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Meningitis	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Nasopharyngitis	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Otitis media acute	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		1/267 (0.4%)		0/150 (0%)		0/133 (0%)
Pneumonia	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		1/267 (0.4%)		0/150 (0%)		0/133 (0%)
Pyelonephritis	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		1/299 (0.3%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		1/267 (0.4%)		0/150 (0%)		0/133 (0%)
Respiratory syncytial virus bronchiolitis	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Urinary tract infection	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Injury, poisoning and procedural complications
Head injury	1/304 (0.3%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Joint injury	0/304 (0%)		0/309 (0%)		0/290 (0%)		1/299 (0.3%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Metabolism and nutrition disorders
Dehydration	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		1/267 (0.4%)		0/150 (0%)		0/133 (0%)
Nervous system disorders
Hypotonia	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/273 (0.4%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		1/150 (0.7%)		0/133 (0%)
Foreign body aspiration	0/304 (0%)		0/309 (0%)		0/290 (0%)		1/299 (0.3%)		0/273 (0%)		0/152 (0%)		0/134 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Lung disorder	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/273 (0%)		0/152 (0%)		1/134 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Other (Not Including Serious) Adverse Events
	13vPnC Infant Series		7vPnC Infant Series		13vPnC Post-Infant Series		7vPnC Post-Infant Series		13vPnC/13vPnC Toddler Dose		7vPnC/7vPnC Toddler Dose		7vPnC/ 13vPnC Toddler Dose		13vPnC / 13vPnC 6-Month Follow-up		7vPnC / 7vPnC 6-Month Follow-up		7vPnC / 13vPnC 6-Month Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	142/304 (46.7%)		162/309 (52.4%)		12/290 (4.1%)		11/299 (3.7%)		125/272 (46%)		64/152 (42.1%)		63/137 (46%)		2/267 (0.7%)		2/150 (1.3%)		2/133 (1.5%)
Blood and lymphatic system disorders
Anaemia	0/304 (0%)		0/309 (0%)		0/290 (0%)		1/299 (0.3%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Microcytic anaemia	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		1/133 (0.8%)
Congenital, familial and genetic disorders
Dacryostenosis congenital	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Ear and labyrinth disorders
Ear pain	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		1/152 (0.7%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Eye disorders
Conjunctivitis	6/304 (2%)		13/309 (4.2%)		0/290 (0%)		0/299 (0%)		3/272 (1.1%)		1/152 (0.7%)		3/137 (2.2%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Hypermetropia	0/304 (0%)		0/309 (0%)		0/290 (0%)		1/299 (0.3%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Gastrointestinal disorders
Diarrhoea	6/304 (2%)		3/309 (1%)		1/290 (0.3%)		1/299 (0.3%)		3/272 (1.1%)		1/152 (0.7%)		1/137 (0.7%)		1/267 (0.4%)		0/150 (0%)		0/133 (0%)
Vomiting	7/304 (2.3%)		2/309 (0.6%)		0/290 (0%)		1/299 (0.3%)		1/272 (0.4%)		1/152 (0.7%)		2/137 (1.5%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Regurgitation	1/304 (0.3%)		4/309 (1.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Gastrooesophageal reflux disease	2/304 (0.7%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		1/150 (0.7%)		0/133 (0%)
Abdominal pain	0/304 (0%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Dental discomfort	0/304 (0%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Infantile colic	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Anal fissure	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		1/152 (0.7%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Colitis	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Dyspepsia	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Frequent bowel movements	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Gastrointestinal inflammation	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Oesophagitis	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Toothache	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
General disorders
Injection site erythema	17/304 (5.6%)		16/309 (5.2%)		0/290 (0%)		0/299 (0%)		3/272 (1.1%)		3/152 (2%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Pyrexia	10/304 (3.3%)		13/309 (4.2%)		0/290 (0%)		1/299 (0.3%)		5/272 (1.8%)		7/152 (4.6%)		4/137 (2.9%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Chills	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Hyperthermia	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Injection site induration	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Injection site pain	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Injection site reaction	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Injection site swelling	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Fever ≥38°C but ≤39°C	33/244 (13.5%)		25/250 (10%)		0/0 (NaN)		0/0 (NaN)		64/174 (36.8%)		41/99 (41.4%)		35/83 (42.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever ≥38°C but ≤39°C	42/212 (19.8%)		55/217 (25.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever ≥38°C but ≤39°C	54/201 (26.9%)		58/208 (27.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39°C but ≤40°C	2/238 (0.8%)		1/245 (0.4%)		0/0 (NaN)		0/0 (NaN)		7/153 (4.6%)		2/89 (2.2%)		3/73 (4.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39°C but ≤40°C	2/201 (1%)		5/205 (2.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39°C but ≤40°C	1/184 (0.5%)		3/191 (1.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40°C	0/238 (0%)		0/245 (0%)		0/0 (NaN)		0/0 (NaN)		1/153 (0.7%)		0/88 (0%)		0/73 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40°C	0/200 (0%)		0/205 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40°C	1/184 (0.5%)		0/190 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	60/243 (24.7%)		58/251 (23.1%)		0/0 (NaN)		0/0 (NaN)		49/167 (29.3%)		33/96 (34.4%)		26/83 (31.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	39/211 (18.5%)		57/218 (26.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	45/194 (23.2%)		42/199 (21.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	142/261 (54.4%)		139/265 (52.5%)		0/0 (NaN)		0/0 (NaN)		90/178 (50.6%)		46/99 (46.5%)		46/91 (50.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	112/232 (48.3%)		118/238 (49.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	91/217 (41.9%)		85/211 (40.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	87/256 (34%)		107/259 (41.3%)		0/0 (NaN)		0/0 (NaN)		35/163 (21.5%)		22/92 (23.9%)		19/81 (23.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	61/215 (28.4%)		73/227 (32.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	46/194 (23.7%)		58/204 (28.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	69/246 (28%)		52/253 (20.6%)		0/0 (NaN)		0/0 (NaN)		44/168 (26.2%)		21/93 (22.6%)		25/81 (30.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	57/215 (26.5%)		59/218 (27.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	51/203 (25.1%)		41/196 (20.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Immune system disorders
Milk allergy	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		1/299 (0.3%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Infections and infestations
Rhinitis	25/304 (8.2%)		39/309 (12.6%)		0/290 (0%)		2/299 (0.7%)		8/272 (2.9%)		3/152 (2%)		2/137 (1.5%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Nasopharyngitis	23/304 (7.6%)		32/309 (10.4%)		0/290 (0%)		0/299 (0%)		5/272 (1.8%)		4/152 (2.6%)		9/137 (6.6%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Gastroenteritis	8/304 (2.6%)		19/309 (6.1%)		2/290 (0.7%)		0/299 (0%)		10/272 (3.7%)		5/152 (3.3%)		4/137 (2.9%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Bronchiolitis	14/304 (4.6%)		5/309 (1.6%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		3/152 (2%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Bronchitis	6/304 (2%)		12/309 (3.9%)		2/290 (0.7%)		0/299 (0%)		8/272 (2.9%)		6/152 (3.9%)		4/137 (2.9%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Ear infection	5/304 (1.6%)		8/309 (2.6%)		1/290 (0.3%)		0/299 (0%)		16/272 (5.9%)		6/152 (3.9%)		5/137 (3.6%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Tracheitis	3/304 (1%)		9/309 (2.9%)		0/290 (0%)		0/299 (0%)		7/272 (2.6%)		0/152 (0%)		2/137 (1.5%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Varicella	5/304 (1.6%)		6/309 (1.9%)		0/290 (0%)		0/299 (0%)		3/272 (1.1%)		2/152 (1.3%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Pharyngitis	4/304 (1.3%)		5/309 (1.6%)		0/290 (0%)		0/299 (0%)		2/272 (0.7%)		2/152 (1.3%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Bronchitis viral	2/304 (0.7%)		3/309 (1%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Fungal skin infection	3/304 (1%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Rhinotracheitis	2/304 (0.7%)		3/309 (1%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Roseola	1/304 (0.3%)		3/309 (1%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Viral infection	2/304 (0.7%)		2/309 (0.6%)		0/290 (0%)		1/299 (0.3%)		0/272 (0%)		1/152 (0.7%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Fungal infection	3/304 (1%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Laryngitis	1/304 (0.3%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		2/272 (0.7%)		0/152 (0%)		2/137 (1.5%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Oral candidiasis	3/304 (1%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Candidiasis	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Rhinolaryngitis	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Urinary tract infection	0/304 (0%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Viral skin infection	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Dacryocystitis	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Erythema infectiosum	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Furuncle	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Influenza	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Otitis media	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		3/272 (1.1%)		1/152 (0.7%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Otitis media acute	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Tracheobronchitis	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		1/152 (0.7%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Otitis media chronic	0/304 (0%)		0/309 (0%)		1/290 (0.3%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Exanthema subitum	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Genital candidiasis	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Human herpesvirus 6 infection	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		1/152 (0.7%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Oral herpes	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Pyelonephritis	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Tonsillitis	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Infectious mononucleosis	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		1/150 (0.7%)		0/133 (0%)
Injury, poisoning and procedural complications
Arthropod sting	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Humerus fracture	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Investigations
Bacteria stool identified	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Anorexia	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Nervous system disorders
Facial palsy	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		1/150 (0.7%)		0/133 (0%)
Psychiatric disorders
Crying	0/304 (0%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Agitation	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	4/304 (1.3%)		6/309 (1.9%)		0/290 (0%)		1/299 (0.3%)		1/272 (0.4%)		2/152 (1.3%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Rhinorrhoea	3/304 (1%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Allergic respiratory disease	0/304 (0%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Asthma	1/304 (0.3%)		1/309 (0.3%)		3/290 (1%)		3/299 (1%)		1/272 (0.4%)		1/152 (0.7%)		1/137 (0.7%)		1/267 (0.4%)		0/150 (0%)		0/133 (0%)
Wheezing	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		1/272 (0.4%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Bronchial hyperreactivity	0/304 (0%)		0/309 (0%)		0/290 (0%)		1/299 (0.3%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Skin and subcutaneous tissue disorders
Eczema	13/304 (4.3%)		8/309 (2.6%)		1/290 (0.3%)		0/299 (0%)		1/272 (0.4%)		1/152 (0.7%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Dermatitis atopic	1/304 (0.3%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Erythema	0/304 (0%)		3/309 (1%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		1/152 (0.7%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Rash	1/304 (0.3%)		2/309 (0.6%)		0/290 (0%)		0/299 (0%)		4/272 (1.5%)		0/152 (0%)		1/137 (0.7%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Urticaria	1/304 (0.3%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		3/272 (1.1%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Dermatitis allergic	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Heat rash	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Nail bed inflammation	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Petechiae	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Rash morbilliform	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Eczema asteatotic	0/304 (0%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		1/133 (0.8%)
Tenderness (Any)	98/256 (38.3%)		99/257 (38.5%)		0/0 (NaN)		0/0 (NaN)		95/189 (50.3%)		43/96 (44.8%)		57/89 (64%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Any)	74/223 (33.2%)		95/225 (42.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Any)	76/210 (36.2%)		66/206 (32%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	13/237 (5.5%)		12/245 (4.9%)		0/0 (NaN)		0/0 (NaN)		8/155 (5.2%)		4/86 (4.7%)		6/75 (8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	11/203 (5.4%)		14/208 (6.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	7/188 (3.7%)		6/193 (3.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	105/254 (41.3%)		99/256 (38.7%)		0/0 (NaN)		0/0 (NaN)		99/185 (53.5%)		57/99 (57.6%)		58/97 (59.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	113/226 (50%)		128/235 (54.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	105/217 (48.4%)		112/219 (51.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	92/249 (36.9%)		91/255 (35.7%)		0/0 (NaN)		0/0 (NaN)		87/181 (48.1%)		55/99 (55.6%)		55/95 (57.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	104/223 (46.6%)		119/232 (51.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	95/213 (44.6%)		98/214 (45.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	35/243 (14.4%)		23/246 (9.3%)		0/0 (NaN)		0/0 (NaN)		31/159 (19.5%)		14/88 (15.9%)		17/82 (20.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	29/207 (14%)		30/208 (14.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	27/193 (14%)		31/194 (16%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/235 (0%)		0/244 (0%)		0/0 (NaN)		0/0 (NaN)		1/152 (0.7%)		0/87 (0%)		0/73 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/199 (0%)		0/203 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/184 (0%)		0/188 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	114/256 (44.5%)		122/260 (46.9%)		0/0 (NaN)		0/0 (NaN)		125/187 (66.8%)		64/106 (60.4%)		63/99 (63.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	126/236 (53.4%)		140/241 (58.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	126/226 (55.8%)		132/223 (59.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/133 (0%)
Erythema (Mild)	103/252 (40.9%)		118/259 (45.6%)		0/0 (NaN)		0/0 (NaN)		108/180 (60%)		58/106 (54.7%)		57/95 (60%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Mild)	119/234 (50.9%)		136/240 (56.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Mild)	117/223 (52.5%)		123/221 (55.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	23/241 (9.5%)		9/245 (3.7%)		0/0 (NaN)		0/0 (NaN)		40/165 (24.2%)		16/87 (18.4%)		16/79 (20.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	15/205 (7.3%)		14/206 (6.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	17/190 (8.9%)		24/192 (12.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/234 (0%)		0/244 (0%)		0/0 (NaN)		0/0 (NaN)		1/152 (0.7%)		0/86 (0%)		0/73 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/199 (0%)		0/203 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/184 (0%)		0/188 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Social circumstances
Child abuse	0/304 (0%)		1/309 (0.3%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)
Vascular disorders
Haematoma	1/304 (0.3%)		0/309 (0%)		0/290 (0%)		0/299 (0%)		0/272 (0%)		0/152 (0%)		0/137 (0%)		0/267 (0%)		0/150 (0%)		0/133 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

Results Point of Contact

Name/Title	U. S. Contact Center
Organization	Wyeth
Phone
Email	clintrialresults@wyeth.com

Responsible Party:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00366678

Other Study ID Numbers:

6096A1-008

First Posted:

Aug 21, 2006

Last Update Posted:

Aug 15, 2012

Last Verified:

Jul 1, 2012