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

NCT00366340

Collaborator

(none)

604

Enrollment

Locations

Arms

Duration (Months)

11.8

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 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

604 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 of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 13-valent pneumococcal conjugate vaccine	Biological: 13-valent pneumococcal conjugate vaccine Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Active Comparator: 2 7-valent pneumococcal conjugate vaccine	Biological: 7-valent pneumococcal conjugate vaccine Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Arm

Intervention/Treatment

Experimental: 1

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Active Comparator: 2

7-valent pneumococcal conjugate vaccine

Biological: 7-valent pneumococcal conjugate vaccine

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [One month after 3-dose infant series (5 months of age)]
Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [One month after 3-dose infant series (5 months of age)]
Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. [One month after 3-dose infant series (5 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 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [One month after 3-dose infant series (5 months of age)]
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [Immediately before (12 months of age) and one month after the toddler dose (13 months of age)]
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Percentage of Participants Reporting Pre-Specified Local Reactions [Day 1 through 4 after each dose]
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) [Day 1 through 4 after each dose]
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) [Day 1 through 4 after each dose]
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

Eligibility Criteria

Criteria

Ages Eligible for Study:

56 Days to 112 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 2 months (56 to 112 days) at time of enrollment.
Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion criteria:

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.
History of culture-proven invasive disease caused by S pneumoniae or H influenzae type

Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Contacts and Locations

Locations

	City	Country	Postal Code
1	Bad Kreuznach	Germany	55543
2	Bad Saulgau	Germany	88348
3	Bad Sobernheim	Germany	55566
4	Berlin	Germany	10551
5	Berlin	Germany	10967
6	Berlin	Germany	13355
7	Berlin	Germany	13409
8	Berlin	Germany	13507
9	Berlin	Germany	13627
10	Birkenfeld	Germany	75217
11	Bobingen	Germany	86399
12	Bramsche	Germany	49565
13	Bretten	Germany	75015
14	Cham	Germany	93413
15	Ehingen	Germany	89584
16	Erlangen	Germany	91056
17	Eschwege	Germany	37269
18	Flensburg	Germany	24939
19	Gau-Odernheim	Germany	55239
20	Hamburg	Germany	22763
21	Herzogenaurach	Germany	91074
22	Hoechberg	Germany	97204
23	Kehl	Germany	77694
24	Kiel	Germany	24111
25	Kleve	Germany	47533
26	Krefeld	Germany	47798
27	Ludwigshafen	Germany	67059
28	Luebeck	Germany	23568
29	Mainz	Germany	55101
30	Metzingen	Germany	72555
31	Minden	Germany	32427
32	Muenster	Germany	48159
33	Muenster	Germany	48165
34	Neumuenster	Germany	24534
35	NeumÃ¼nster	Germany	24534
36	Neustadt/Aisch	Germany	91413
37	Niebuell	Germany	25899
38	Nuernberg	Germany	90473
39	Nuernberg	Germany	90482
40	Oberkirch	Germany	77704
41	Olching	Germany	82140
42	Pforzheim	Germany	75172
43	Porta Westfalica	Germany	32457
44	Ravensburg	Germany	88214
45	Tettnang	Germany	88069
46	Vellmar	Germany	34246
47	Weiden	Germany	92637
48	Weilheim	Germany	82362
49	Welzheim	Germany	73642
50	Wiesbaden	Germany	65205
51	Zirndorf	Germany	90513

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 Germany, medinfoDEU@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:

NCT00366340

Other Study ID Numbers:

6096A1-006

First Posted:

Aug 21, 2006

Last Update Posted:

Aug 8, 2012

Last Verified:

Jun 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 Germany from October 2006 to April 2007.
Pre-assignment Detail	Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.

Arm/Group Title	13vPnC	7vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Period Title: Infant Series
STARTED	301	303
Vaccinated Dose 1	300	303
Vaccinated Dose 2	296	297
Vaccinated Dose 3	294	293
COMPLETED	293	293
NOT COMPLETED	8	10
Period Title: Infant Series
STARTED	293	293
COMPLETED	290	287
NOT COMPLETED	3	6
Period Title: Infant Series
STARTED	290	287
COMPLETED	289	286
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	13vPnC	7vPnC	Total
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)	Total of all reporting groups
Overall Participants	301	303	604
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	2.5 (0.6)	2.5 (0.6)	2.5 (0.6)
Sex: Female, Male (Count of Participants)
Female	151 50.2%	127 41.9%	278 46%
Male	150 49.8%	176 58.1%	326 54%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Description	Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	One month after 3-dose infant series (5 months of age)

Outcome Measure Data

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

Arm/Group Title	13vPnC	7vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Measure Participants	285	279
Common Serotypes-Serotype 4	98.2 32.6%	98.2 32.4%
Common Serotypes-Serotype 6B	77.5 25.7%	87.1 28.7%
Common Serotypes-Serotype 9V	98.6 32.8%	96.4 31.8%
Common Serotypes-Serotype 14	98.9 32.9%	97.5 32.2%
Common Serotypes-Serotype 18C	97.2 32.3%	98.6 32.5%
Common Serotypes-Serotype 19F	95.8 31.8%	96.0 31.7%
Common Serotypes-Serotype 23F	88.7 29.5%	89.5 29.5%
Additional Serotypes-Serotype 1	96.1 31.9%	1.4 0.5%
Additional Serotypes-Serotype 3	98.2 32.6%	6.3 2.1%
Additional Serotypes-Serotype 5	93.0 30.9%	31.6 10.4%
Additional Serotypes-Serotype 6A	91.9 30.5%	31.6 10.4%
Additional Serotypes-Serotype 7F	98.6 32.8%	4.0 1.3%
Additional Serotypes-Serotype 19A	99.3 33%	79.2 26.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95% -2.5 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-9.6
	Confidence Interval	(2-Sided) 95% -16.0 to -3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95% -0.4 to 5.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95% -0.9 to 4.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95% -4.2 to 1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95% -3.8 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95% -6.0 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Description	Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Time Frame	One month after 3-dose infant series (5 months of age)

Outcome Measure Data

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

Arm/Group Title	13vPnC	7vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Measure Participants	285	279
Common Serotypes - Serotype 4	2.18	2.99
Common Serotypes - Serotype 6B	0.98	1.49
Common Serotypes - Serotype 9V	1.65	1.96
Common Serotypes - Serotype 14	4.14	4.61
Common Serotypes - Serotype 18C	1.94	2.25
Common Serotypes - Serotype 19F	1.73	2.86
Common Serotypes - Serotype 23F	1.26	1.44
Additional Serotypes - Serotype 1	1.83	0.03
Additional Serotypes - Serotype 3	1.55	0.05
Additional Serotypes - Serotype 5	1.31	0.20
Additional Serotypes - Serotype 6A	1.33	0.23
Additional Serotypes - Serotype 7F	2.59	0.04
Additional Serotypes - Serotype 19A	3.26	0.64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95% 0.63 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95% 0.52 to 0.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 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	(2-Sided) 95% 0.74 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% 0.76 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	2.25
	Confidence Interval	(2-Sided) 95% 2.04 to 2.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95% 0.51 to 0.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 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	(2-Sided) 95% 0.73 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
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 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 3-dose infant series (5 months of age)

Outcome Measure Data

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

Arm/Group Title	13vPnC	7vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Measure Participants	285	279
Common Serotypes - Serotype 4 (n=92,94)	100.0 33.2%	100.0 33%
Common Serotypes - Serotype 6B (n=100,94)	96.0 31.9%	98.9 32.6%
Common Serotypes - Serotype 9V (n=89,89)	100.0 33.2%	100.0 33%
Common Serotypes - Serotype 14 (n=95,89)	100.0 33.2%	100.0 33%
Common Serotypes - Serotype 18C (n=100,94)	100.0 33.2%	98.9 32.6%
Common Serotypes - Serotype 19F (n=100,94)	96.0 31.9%	93.6 30.9%
Common Serotypes - Serotype 23F (n=100,93)	96.0 31.9%	95.7 31.6%
Additional Serotypes - Serotype 1 (n=100,92)	93.0 30.9%	4.3 1.4%
Additional Serotypes - Serotype 3 (n=100,94)	99.0 32.9%	24.5 8.1%
Additional Serotypes - Serotype 5 (n=100,94)	99.0 32.9%	4.3 1.4%
Additional Serotypes - Serotype 6A (n=99,93)	96.0 31.9%	72.0 23.8%
Additional Serotypes - Serotype 7F (n=99,94)	100.0 33.2%	78.7 26%
Additional Serotypes - Serotype 19A (n=95,94)	100.00 33.2%	17.0 5.6%

4. Primary Outcome

Title	Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Description	Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	One month after 3-dose infant series (5 months of age)

Outcome Measure Data

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

Arm/Group Title	13vPnC	7vPnC
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Measure Participants	285	279
Common Serotypes -Serotype 4 (n=92,94)	1573.29	1860.79
Common Serotypes - Serotype 6B (n=100,94)	744.43	1160.76
Common Serotypes - Serotype 9V (n=89,89)	4937.84	5379.51
Common Serotypes - Serotype 14 (n=95,89)	2139.65	3345.19
Common Serotypes - Serotype 18C (n=100,94)	1509.65	1780.26
Common Serotypes - Serotype 19F (n=100,94)	150.12	165.69
Common Serotypes - Serotype 23F (n=100,93)	1089.92	1070.83
Additional Serotypes - Serotype 1 (n=100,92)	50.21	4.15
Additional Serotypes - Serotype 3 (n=100,94)	250.73	6.13
Additional Serotypes - Serotype 5 (n=100,94)	162.02	4.64
Additional Serotypes - Serotype 6A (n=99,93)	1228.45	122.40
Additional Serotypes - Serotype 7F (n=99,94)	11544.75	115.45
Additional Serotypes - Serotype 19A (n=95,94)	442.48	6.70

5. Primary Outcome

Title	Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Description	Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Time Frame	One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.

Arm/Group Title	13vPnC After Infant Series	7vPnC After Infant Series	13vPnC After Toddler Dose	7vPnC After Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Measure Participants	267	252	252	242
Haemophilus influenzae type b 0.15 µg/mL threshold	89.5 29.7%	86.9 28.7%	100.0 16.6%	100.0 NaN
Haemophilus influenzae type b 1.0 µg/mL threshold	58.4 19.4%	54.0 17.8%	99.6 16.5%	97.9 NaN
Diphtheria toxoid at 0.01 IU/mL threshold	100.0 33.2%	100.0 33%	100.0 16.6%	100.0 NaN
Diphtheria toxoid at 0.1 IU/mL threshold	89.7 29.8%	94.2 31.1%	100.0 16.6%	100.0 NaN
Hepatitis B at ≥ 10.0 mIU/mL	94.9 31.5%	96.3 31.8%	99.3 16.4%	98.5 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For Haemophilus influenzae type b the difference in percentage 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	2.6
	Confidence Interval	(2-Sided) 95% -3.0 to 8.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For Haemophilus influenzae type b 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	(2-Sided) 95% -4.1 to 13.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For diphtheria toxoid 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 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For diphtheria toxoid 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	-4.5
	Confidence Interval	() 95% -9.3 to 0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For Haemophilus Influenzae Type b 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	(2-Sided) 95% -1.5 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/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	-1.3
	Confidence Interval	() 95% -5.0 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For Haemophilus influenzae type b 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	1.7
	Confidence Interval	(2-Sided) 95% -0.4 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For diphtheria toxoid 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 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For diphtheria toxoid 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	0.0
	Confidence Interval	() 95% -1.4 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/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% -1.3 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Description
Time Frame	One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to 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 concomitant antigen.

Arm/Group Title	13vPnC After Infant Series	7vPnC After Infant Series	13vPnC AfterToddler Dose	7vPnC AfterToddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Measure Participants	267	252	285	279
Geometric Mean (95% Confidence Interval) [μg/mL]	1.23	1.00	11.79	10.24

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for the 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	1.23
	Confidence Interval	(2-Sided) 95% 0.96 to 1.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for the 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	1.15
	Confidence Interval	(2-Sided) 95% 0.95 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Description
Time Frame	One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to 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 concomitant antigen.

Arm/Group Title	13vPnC After Infant Series	7vPnC After Infant Series	13vPnC AfterToddler Dose	7vPnC AfterToddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Measure Participants	272	258	285	279
Geometric Mean (95% Confidence Interval) [IU/mL]	0.36	0.53	2.67	3.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for the 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	0.68
	Confidence Interval	(2-Sided) 95% 0.57 to 0.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for the 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	(2-Sided) 95% 0.75 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Description	Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to 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 concomitant antigen.

Arm/Group Title	13vPnC After Infant Series	7vPnC After Infant Series	13vPnC AfterToddler Dose	7vPnC AfterToddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Measure Participants	277	268	285	279
Geometric Mean (95% Confidence Interval) [mIU/mL]	145.19	165.25	1118.05	1195.82

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC, 7vPnC
	Comments	For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for the 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	(2-Sided) 95% 0.69 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC After Toddler Dose, 7vPnC After Toddler Dose
	Comments	For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for the 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	0.93
	Confidence Interval	(2-Sided) 95% 0.71 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Primary Outcome

Title	Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Description	Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame	Immediately before (12 months of age) and one month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to 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 concomitant antigen.

Arm/Group Title	13vPnC Before Toddler Dose	7vPnC Before Toddler Dose	13vPnC After Toddler Dose	7vPnC After Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
Measure Participants	285	279	285	279
Common Serotypes -Serotype 4 (n=277,264,276,263)	0.46	0.58	4.16	5.07
Common Serotypes - Serotype 6B (n=275,261,273,251)	0.97	1.06	9.14	9.85
Common Serotypes - Serotype 9V (n=277,265,277,262)	0.46	0.52	2.75	3.36
Common Serotypes - Serotype 14 (n=273,263,276,260)	2.20	2.65	8.34	11.01
Common Serotypes-Serotype 18C (n=277,265,276,263)	0.33	0.39	2.79	3.44
Common Serotypes-Serotype 19F (n=276,264,276,263)	0.68	0.58	5.99	4.72
Common Serotypes-Serotype 23F (n=275,264,277,264)	0.33	0.39	3.36	4.33
Additional - Serotype 1 (n=277,264,278,257)	0.52	0.03	4.25	0.03
Additional - Serotype 3 (n=275,264,278,255)	0.25	0.05	1.02	0.07
Additional - Serotype 5 (n=275,264,276,220)	0.74	0.34	3.56	0.51
Additional - Serotype 6A (n=276,264,274,255)	0.76	0.33	5.88	1.74
Additional - Serotype 7F (n=277,264,278,263)	0.99	0.04	4.79	0.05
Additional - Serotype 19A (n=277,264,271,260)	1.28	0.72	9.58	3.79

10. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame	Day 1 through 4 after each dose

Outcome Measure Data

Analysis Population Description
Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.

Arm/Group Title	13vPnC Dose 1	7vPnC Dose 1	13vPnC Dose 2	7vPnC Dose 2	13vPnC Dose 3	7vPnC Dose 3	13vPnC Toddler Dose	7vPnC Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
Measure Participants	300	303	296	297	294	293	290	287
Tenderness-Any (n=267,267,250,241,229,221,206,96)	33.0 11%	32.6 10.8%	29.2 4.8%	31.5 NaN	27.1 NaN	21.3 NaN	53.4 NaN	51.9 NaN
Tenderness-Sig (n=260,258,236,226,215,209,176,158)	7.7 2.6%	7.0 2.3%	4.7 0.8%	7.5 NaN	4.2 NaN	2.9 NaN	10.8 NaN	12.7 NaN
Swelling-Any (n=266,263,244,242,226,224,190,176)	28.2 9.4%	20.5 6.8%	26.6 4.4%	35.1 NaN	26.1 NaN	28.6 NaN	36.8 NaN	43.8 NaN
Swelling-Mild (n=265,263,243,239,226,223,186,172)	24.5 8.1%	19.0 6.3%	24.3 4%	33.5 NaN	24.8 NaN	27.8 NaN	33.3 NaN	40.7 NaN
Swelling-Mod (n=261,256,235,227,217,211,174,158)	7.3 2.4%	5.9 1.9%	7.7 1.3%	6.6 NaN	6.9 NaN	5.2 NaN	12.1 NaN	12.7 NaN
Swelling-Severe(n=259,255,232,223,214,208,166,152)	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN
Redness-Any (n=266,272,247,252,238,231,196,184)	28.2 9.4%	36.4 12%	34.4 5.7%	46.8 NaN	34.9 NaN	39.8 NaN	47.4 NaN	56.0 NaN
Redness-Mild (n=265,271,247,250,237,229,191,180)	27.2 9%	36.2 11.9%	33.6 5.6%	45.6 NaN	34.2 NaN	38.9 NaN	44.5 NaN	52.8 NaN
Redness-Mod (n=260,256,232,224,217,210,173,158)	1.9 0.6%	1.6 0.5%	1.7 0.3%	3.6 NaN	4.6 NaN	2.4 NaN	11.6 NaN	15.2 NaN
Redness-Severe (n=259,255,232,222,214,208,166,153)	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN	0.0 NaN	0.7 NaN

11. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Description	Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Day 1 through 4 after each dose

Outcome Measure Data

Analysis Population Description
Safety population, participants who received given dose; (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
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
Measure Participants	300	303	296	297	294	293
Fever ≥38°C but ≤ 39°C (n=269,266,248,250,242,232)	43.5 14.5%	38.7 12.8%	46.8 7.7%	48.4 NaN	46.3 NaN	36.6 NaN
Fever >39°C but ≤40°C (n=260,256,238,225,216,210)	4.2 1.4%	1.6 0.5%	8.8 1.5%	4.4 NaN	3.7 NaN	1.4 NaN
Fever >40°C (n=259,256,233,223,216,209)	0.0 0%	0.0 0%	0.0 0%	0.0 NaN	0.0 NaN	0.0 NaN
Decreased Appetite (n=269,267,249,245,236,225)	33.1 11%	30.3 10%	33.7 5.6%	34.3 NaN	33.1 NaN	30.2 NaN
Irritability (n=275,266,254,252,238,235)	42.5 14.1%	45.1 14.9%	47.2 7.8%	55.2 NaN	45.4 NaN	48.9 NaN
Increased Sleep (n=284,272,258,256,240,241)	61.6 20.5%	58.8 19.4%	53.9 8.9%	66.8 NaN	49.6 NaN	49.4 NaN
Decreased Sleep (n=266,264,240,234,230,221)	25.2 8.4%	26.1 8.6%	23.8 3.9%	23.1 NaN	20.9 NaN	24.4 NaN
Meds to Prevent Sx (n=261,262,237,234,220,220)	8.8 2.9%	9.5 3.1%	10.1 1.7%	15.4 NaN	10.0 NaN	15.0 NaN
Meds to Treat Sx (n=263,266,244,235,226,225)	20.2 6.7%	21.1 7%	28.3 4.7%	27.2 NaN	20.8 NaN	19.1 NaN

12. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Description	Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Day 1 through 4 after each dose

Outcome Measure Data

Analysis Population Description
Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.

Arm/Group Title	13vPnC Toddler Dose	7vPnC Toddler Dose
Arm/Group Description	Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.	Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
Measure Participants	290	287
Fever ≥38°C but ≤ 39°C (n=206,200)	58.7 19.5%	62.0 20.5%
Fever >39°C but ≤40°C (n=174,157)	12.6 4.2%	8.9 2.9%
Fever >40°C (n=166,152)	0.6 0.2%	0.0 0%
Decreased Appetite (n=204,192)	43.6 14.5%	46.4 15.3%
Irritability (n=213,200)	55.4 18.4%	61.0 20.1%
Increased Sleep (n=202,197)	56.4 18.7%	54.8 18.1%
Decreased Sleep (n=195,170)	31.8 10.6%	28.8 9.5%
Medication to Prevent Symptoms (n=184,182)	32.1 10.7%	33.0 10.9%
Medication to Treat Symptoms (n=178,167)	18.0 6%	18.6 6.1%

Adverse Events

	13vPnC Infant Series		7vPnC Infant Series		13vPnC Post-Infant Series		7vPnC Post-Infant Series		13vPnC Toddler Dose		7vPnC Toddler Dose		13vPnC 6-Month Follow-up		7vPnC 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 Toddler Dose		7vPnC Toddler Dose		13vPnC 6-Month Follow-up		7vPnC 6-Month Follow-up
Arm/Group Description	Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.		Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.		Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.		Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.		Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.		Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.		Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.		Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). 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
Total	/ (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 Toddler Dose		7vPnC Toddler Dose		13vPnC 6-Month Follow-up		7vPnC 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
Total	12/300 (4%)		10/303 (3.3%)		21/300 (7%)		23/303 (7.6%)		3/300 (1%)		4/303 (1.3%)		11/300 (3.7%)		14/303 (4.6%)
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Gastrointestinal disorders
Aphthous stomatitis	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Gastrooesophageal reflux disease	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Ileus paralytic	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Inguinal hernia	0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Intussusception	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Mechanical ileus	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
General disorders
Pyrexia	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Infections and infestations
Bronchiolitis	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Bronchitis	2/300 (0.7%)		4/303 (1.3%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)
Bronchopneumonia	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Croup infectious	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Cystitis	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Ear infection	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Enteritis infectious	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Febrile infection	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Gastroenteritis	1/300 (0.3%)		0/303 (0%)		1/300 (0.3%)		4/303 (1.3%)		1/300 (0.3%)		1/303 (0.3%)		3/300 (1%)		3/303 (1%)
Gastroenteritis norovirus	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Gastroenteritis rotavirus	2/300 (0.7%)		2/303 (0.7%)		2/300 (0.7%)		3/303 (1%)		1/300 (0.3%)		1/303 (0.3%)		1/300 (0.3%)		3/303 (1%)
Otitis media	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Periorbital cellulitis	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Pharyngotonsillitis	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Pneumonia	0/300 (0%)		1/303 (0.3%)		1/300 (0.3%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Pneumonia respiratory syncytial viral	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Pyelonephritis	0/300 (0%)		0/303 (0%)		0/300 (0%)		2/303 (0.7%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Pyelonephritis acute	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Respiratory syncytial virus bronchiolitis	0/300 (0%)		2/303 (0.7%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Rhinitis	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Rotavirus infection	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Upper respiratory tract infection	0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)
Urinary tract infection	1/300 (0.3%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Viral infection	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Viral tonsillitis	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Injury, poisoning and procedural complications
Accidental exposure	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Brain contusion	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Chemical poisoning	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		1/303 (0.3%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Concussion	0/300 (0%)		1/303 (0.3%)		1/300 (0.3%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Contusion	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Exposure to toxic agent	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Head injury	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Laceration	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Nicotine poisoning	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)
Skeletal injury	0/300 (0%)		0/303 (0%)		2/300 (0.7%)		3/303 (1%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		2/303 (0.7%)
Metabolism and nutrition disorders
Acidosis	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Decreased appetite	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Dehydration	0/300 (0%)		0/303 (0%)		0/300 (0%)		1/303 (0.3%)		1/300 (0.3%)		0/303 (0%)		2/300 (0.7%)		1/303 (0.3%)
Failure to thrive	1/300 (0.3%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Metabolic acidosis	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Musculoskeletal and connective tissue disorders
Muscle twitching	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Nervous system disorders
Febrile convulsion	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		1/303 (0.3%)		0/300 (0%)		1/303 (0.3%)		0/300 (0%)		2/303 (0.7%)
Renal and urinary disorders
Vesicoureteric reflux	0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)
Reproductive system and breast disorders
Epididymitis	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Respiratory, thoracic and mediastinal disorders
Apnoeic attack	1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Respiratory failure	0/300 (0%)		0/303 (0%)		1/300 (0.3%)		0/303 (0%)		0/300 (0%)		0/303 (0%)		0/300 (0%)		0/303 (0%)
Other (Not Including Serious) Adverse Events
	13vPnC Infant Series		7vPnC Infant Series		13vPnC Post-Infant Series		7vPnC Post-Infant Series		13vPnC Toddler Dose		7vPnC Toddler Dose		13vPnC 6-Month Follow-up		7vPnC 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
Total	220/299 (73.6%)		225/300 (75%)		13/299 (4.3%)		25/300 (8.3%)		152/289 (52.6%)		143/284 (50.4%)		11/287 (3.8%)		8/287 (2.8%)
Blood and lymphatic system disorders
Iron deficiency anaemia	2/299 (0.7%)		1/300 (0.3%)		0/299 (0%)		1/300 (0.3%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Anaemia	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Mastocytosis	0/299 (0%)		0/300 (0%)		1/299 (0.3%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Congenital, familial and genetic disorders
Dacryostenosis congenital	0/299 (0%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Congenital torticollis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Craniotabes	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Cryptorchism	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Hereditary fructose intolerance	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Macrocephaly	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Naevus flammeus	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pectus excavatum	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Plagiocephaly	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
21-hydroxylase deficiency	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		0/287 (0%)
Ear and labyrinth disorders
Middle ear disorder	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Ear pain	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Middle ear effusion	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Otosalpingitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Eye disorders
Conjunctivitis	22/299 (7.4%)		25/300 (8.3%)		0/299 (0%)		0/300 (0%)		9/289 (3.1%)		6/284 (2.1%)		0/287 (0%)		0/287 (0%)
Dacryostenosis acquired	1/299 (0.3%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pupils unequal	2/299 (0.7%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Dacryoadenitis acquired	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Eye inflammation	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Eyelid disorder	0/299 (0%)		0/300 (0%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Ocular hyperaemia	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Strabismus	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		1/287 (0.3%)
Hypermetropia	0/299 (0%)		0/300 (0%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		0/287 (0%)
Gastrointestinal disorders
Diarrhoea	21/299 (7%)		14/300 (4.7%)		0/299 (0%)		0/300 (0%)		4/289 (1.4%)		8/284 (2.8%)		1/287 (0.3%)		0/287 (0%)
Flatulence	11/299 (3.7%)		8/300 (2.7%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Constipation	11/299 (3.7%)		6/300 (2%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Vomiting	8/299 (2.7%)		7/300 (2.3%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Teething	6/299 (2%)		8/300 (2.7%)		0/299 (0%)		2/300 (0.7%)		4/289 (1.4%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Dyspepsia	5/299 (1.7%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Infantile colic	2/299 (0.7%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Dental discomfort	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Anal prolapse	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Aphthous stomatitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Enteritis	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Stomatitis	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Abdominal pain	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Cheilitis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
General disorders
Pyrexia	29/299 (9.7%)		27/300 (9%)		0/299 (0%)		0/300 (0%)		14/289 (4.8%)		28/284 (9.9%)		0/287 (0%)		0/287 (0%)
Injection site swelling	3/299 (1%)		4/300 (1.3%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		5/284 (1.8%)		0/287 (0%)		0/287 (0%)
Injection site erythema	2/299 (0.7%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		4/289 (1.4%)		5/284 (1.8%)		0/287 (0%)		0/287 (0%)
Injection site induration	1/299 (0.3%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		4/284 (1.4%)		0/287 (0%)		0/287 (0%)
Injection site pain	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		4/284 (1.4%)		0/287 (0%)		0/287 (0%)
Injection site reaction	2/299 (0.7%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Injection site haematoma	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pain	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Irritability	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Granuloma	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Developmental delay	0/299 (0%)		0/300 (0%)		1/299 (0.3%)		1/300 (0.3%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Fever ≥38°C but ≤39°C	117/269 (43.5%)		103/266 (38.7%)		0/0 (NaN)		0/0 (NaN)		121/206 (58.7%)		124/200 (62%)		0/0 (NaN)		0/0 (NaN)
Fever ≥38°C but ≤39°C	116/248 (46.8%)		121/250 (48.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever ≥38°C but ≤39°C	112/242 (46.3%)		85/232 (36.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39°C but ≤40°C	11/260 (4.2%)		4/256 (1.6%)		0/0 (NaN)		0/0 (NaN)		22/174 (12.6%)		14/157 (8.9%)		0/0 (NaN)		0/0 (NaN)
Fever >39°C but ≤40°C	21/238 (8.8%)		10/225 (4.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >39°C but ≤40°C	8/216 (3.7%)		3/210 (1.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40°C	0/259 (0%)		0/256 (0%)		0/0 (NaN)		0/0 (NaN)		1/166 (0.6%)		0/152 (0%)		0/0 (NaN)		0/0 (NaN)
Fever >40°C	0/233 (0%)		0/223 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40°C	2/216 (0.9%)		0/209 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	89/269 (33.1%)		81/267 (30.3%)		0/0 (NaN)		0/0 (NaN)		89/204 (43.6%)		89/192 (46.4%)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	84/249 (33.7%)		84/245 (34.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	78/236 (33.1%)		68/225 (30.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	117/275 (42.5%)		120/266 (45.1%)		0/0 (NaN)		0/0 (NaN)		118/213 (55.4%)		122/200 (61%)		0/0 (NaN)		0/0 (NaN)
Irritability	120/254 (47.2%)		139/252 (55.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	108/238 (45.4%)		115/235 (48.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	175/284 (61.6%)		160/272 (58.8%)		0/0 (NaN)		0/0 (NaN)		114/202 (56.4%)		108/197 (54.8%)		0/0 (NaN)		0/0 (NaN)
Increased sleep	139/258 (53.9%)		171/256 (66.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	119/240 (49.6%)		119/241 (49.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	67/266 (25.2%)		69/264 (26.1%)		0/0 (NaN)		0/0 (NaN)		62/195 (31.8%)		49/170 (28.8%)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	57/240 (23.8%)		54/234 (23.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	48/230 (20.9%)		54/221 (24.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Immune system disorders
Hypersensitivity	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Atopy	0/299 (0%)		0/300 (0%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Drug hypersensitivity	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		1/287 (0.3%)
Food allergy	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		1/287 (0.3%)
Infections and infestations
Upper respiratory tract infection	75/299 (25.1%)		64/300 (21.3%)		2/299 (0.7%)		1/300 (0.3%)		40/289 (13.8%)		32/284 (11.3%)		0/287 (0%)		0/287 (0%)
Bronchitis	49/299 (16.4%)		45/300 (15%)		2/299 (0.7%)		2/300 (0.7%)		20/289 (6.9%)		19/284 (6.7%)		0/287 (0%)		0/287 (0%)
Rhinitis	24/299 (8%)		32/300 (10.7%)		2/299 (0.7%)		0/300 (0%)		16/289 (5.5%)		13/284 (4.6%)		0/287 (0%)		0/287 (0%)
Nasopharyngitis	19/299 (6.4%)		28/300 (9.3%)		0/299 (0%)		1/300 (0.3%)		10/289 (3.5%)		14/284 (4.9%)		0/287 (0%)		0/287 (0%)
Gastroenteritis	21/299 (7%)		22/300 (7.3%)		0/299 (0%)		0/300 (0%)		16/289 (5.5%)		11/284 (3.9%)		0/287 (0%)		0/287 (0%)
Viral infection	11/299 (3.7%)		14/300 (4.7%)		0/299 (0%)		0/300 (0%)		5/289 (1.7%)		8/284 (2.8%)		0/287 (0%)		0/287 (0%)
Oral candidiasis	9/299 (3%)		12/300 (4%)		0/299 (0%)		1/300 (0.3%)		1/289 (0.3%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Otitis media	7/299 (2.3%)		13/300 (4.3%)		0/299 (0%)		0/300 (0%)		12/289 (4.2%)		10/284 (3.5%)		0/287 (0%)		0/287 (0%)
Febrile infection	7/299 (2.3%)		10/300 (3.3%)		0/299 (0%)		1/300 (0.3%)		7/289 (2.4%)		5/284 (1.8%)		0/287 (0%)		0/287 (0%)
Candida nappy rash	4/299 (1.3%)		5/300 (1.7%)		0/299 (0%)		1/300 (0.3%)		2/289 (0.7%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Respiratory tract infection	6/299 (2%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Enteritis infectious	3/299 (1%)		5/300 (1.7%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Exanthema subitum	4/299 (1.3%)		4/300 (1.3%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Influenza	2/299 (0.7%)		4/300 (1.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Candidiasis	2/299 (0.7%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Ear infection	3/299 (1%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pharyngitis	2/299 (0.7%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Skin candida	0/299 (0%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Varicella	3/299 (1%)		0/300 (0%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Bacterial infection	2/299 (0.7%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Bronchiolitis	2/299 (0.7%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Genital candidiasis	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Oral fungal infection	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Paronychia	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Respiratory tract infection viral	0/299 (0%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Viral rash	2/299 (0.7%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Viral upper respiratory tract infection	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Abscess	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Bacterial rhinitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Bronchitis bacterial	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Conjunctivitis infective	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Croup infectious	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Eczema infected	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Folliculitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Fungal skin infection	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Gastrointestinal infection	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Infection	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Otitis media acute	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Otitis media viral	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pertussis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pneumonia	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Postoperative wound infection	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pseudocroup	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Scarlet fever	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Sinobronchitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Tinea infection	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Tonsillitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Tonsillitis streptococcal	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Tracheitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Urinary tract infection	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Viral diarrhoea	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Viral rhinitis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Salmonellosis	0/299 (0%)		0/300 (0%)		1/299 (0.3%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Acute tonsillitis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Bronchitis viral	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Bronchopneumonia	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Fungal infection	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Gastroenteritis norovirus	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Gastroenteritis viral	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Herpes virus infection	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Lower respiratory tract infection	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Omphalitis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Otitis externa	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rhinolaryngitis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rotavirus infection	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Tracheobronchitis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Viral skin infection	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Wound infection	0/299 (0%)		0/300 (0%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Injury, poisoning and procedural complications
Contusion	3/299 (1%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Arthropod bite	1/299 (0.3%)		2/300 (0.7%)		1/299 (0.3%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Burns second degree	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Clavicle fracture	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Concussion	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Head injury	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		1/287 (0.3%)		0/287 (0%)
Skeletal injury	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Accidental exposure	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Laceration	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Limb injury	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Mouth injury	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Thermal burn	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Investigations
Weight decreased	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Cardiac murmur	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		1/287 (0.3%)
Blood immunoglobulin e increased	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		0/287 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/299 (0.3%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Feeding disorder neonatal	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		0/287 (0%)
Acidosis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Dehydration	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Failure to thrive	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Obesity	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Oral intake reduced	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hypertriglyceridaemia	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Weight gain poor	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hyperphosphatasaemia	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		1/287 (0.3%)
Musculoskeletal and connective tissue disorders
Posture abnormal	2/299 (0.7%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Arthropathy	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Exostosis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Head deformity	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hypotonia neonatal	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Foot deformity	0/299 (0%)		0/300 (0%)		0/299 (0%)		2/300 (0.7%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Joint range of motion decreased	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Pain in extremity	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Melanocytic naevus	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Nervous system disorders
Coordination abnormal	3/299 (1%)		7/300 (2.3%)		0/299 (0%)		1/300 (0.3%)		0/289 (0%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Hypotonia	1/299 (0.3%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hypersomnia	3/299 (1%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Hypertonia	1/299 (0.3%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hypokinesia	0/299 (0%)		2/300 (0.7%)		0/299 (0%)		2/300 (0.7%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		1/287 (0.3%)
High-pitched crying	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Myotonia	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Poor quality sleep	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Somnolence	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Fine motor delay	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Pseudoparalysis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Psychiatric disorders
Crying	11/299 (3.7%)		10/300 (3.3%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		2/284 (0.7%)		0/287 (0%)		0/287 (0%)
Restlessness	7/299 (2.3%)		14/300 (4.7%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Agitation	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Insomnia	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Screaming	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Sleep disorder	0/299 (0%)		0/300 (0%)		1/299 (0.3%)		0/300 (0%)		3/289 (1%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Renal and urinary disorders
Ureteric stenosis	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Vesicoureteric reflux	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Urinary tract disorder	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Reproductive system and breast disorders
Vulval disorder	5/299 (1.7%)		7/300 (2.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Balanitis	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	12/299 (4%)		7/300 (2.3%)		0/299 (0%)		0/300 (0%)		7/289 (2.4%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Bronchial hyperreactivity	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		1/287 (0.3%)
Bronchial obstruction	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Epistaxis	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Obstructive airways disorder	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Pharyngolaryngeal pain	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Stridor	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Supraclavicular retraction	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Wheezing	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Dysphonia	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Dyspnoea	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Tonsillar disorder	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		0/287 (0%)
Asthma	0/299 (0%)		0/300 (0%)		0/299 (0%)		2/300 (0.7%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		1/287 (0.3%)
Skin and subcutaneous tissue disorders
Dermatitis diaper	22/299 (7.4%)		25/300 (8.3%)		0/299 (0%)		1/300 (0.3%)		17/289 (5.9%)		16/284 (5.6%)		0/287 (0%)		0/287 (0%)
Eczema	10/299 (3.3%)		14/300 (4.7%)		2/299 (0.7%)		0/300 (0%)		3/289 (1%)		5/284 (1.8%)		0/287 (0%)		0/287 (0%)
Eczema infantile	6/299 (2%)		6/300 (2%)		1/299 (0.3%)		0/300 (0%)		3/289 (1%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Seborrhoeic dermatitis	7/299 (2.3%)		5/300 (1.7%)		0/299 (0%)		2/300 (0.7%)		3/289 (1%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rash	4/299 (1.3%)		5/300 (1.7%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		3/284 (1.1%)		0/287 (0%)		0/287 (0%)
Eczema asteatotic	3/299 (1%)		4/300 (1.3%)		0/299 (0%)		0/300 (0%)		2/289 (0.7%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Intertrigo	1/299 (0.3%)		5/300 (1.7%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Dry skin	2/299 (0.7%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Dermatitis	1/299 (0.3%)		3/300 (1%)		0/299 (0%)		0/300 (0%)		3/289 (1%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Neurodermatitis	3/299 (1%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		1/287 (0.3%)		0/287 (0%)
Heat rash	0/299 (0%)		2/300 (0.7%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Dermatitis allergic	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Dermatitis atopic	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hirsutism	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Hyperhidrosis	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Petechiae	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rash maculo-papular	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rash neonatal	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rash papular	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Skin exfoliation	1/299 (0.3%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Skin induration	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Urticaria	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Vitiligo	0/299 (0%)		1/300 (0.3%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Rash generalised	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		0/289 (0%)		1/284 (0.4%)		0/287 (0%)		0/287 (0%)
Xeroderma	0/299 (0%)		0/300 (0%)		0/299 (0%)		0/300 (0%)		1/289 (0.3%)		0/284 (0%)		0/287 (0%)		0/287 (0%)
Tenderness (Any)	88/267 (33%)		87/267 (32.6%)		0/0 (NaN)		0/0 (NaN)		110/206 (53.4%)		96/185 (51.9%)		0/0 (NaN)		0/0 (NaN)
Tenderness (Any)	73/250 (29.2%)		76/241 (31.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Any)	62/229 (27.1%)		47/221 (21.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	20/260 (7.7%)		18/258 (7%)		0/0 (NaN)		0/0 (NaN)		19/176 (10.8%)		20/158 (12.7%)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	11/236 (4.7%)		17/226 (7.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	9/215 (4.2%)		6/209 (2.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	75/266 (28.2%)		54/263 (20.5%)		0/0 (NaN)		0/0 (NaN)		70/190 (36.8%)		77/176 (43.8%)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	65/244 (26.6%)		85/242 (35.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	59/226 (26.1%)		64/224 (28.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	65/265 (24.5%)		50/263 (19%)		0/0 (NaN)		0/0 (NaN)		62/186 (33.3%)		70/172 (40.7%)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	59/243 (24.3%)		80/239 (33.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	56/226 (24.8%)		62/223 (27.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	19/261 (7.3%)		15/256 (5.9%)		0/0 (NaN)		0/0 (NaN)		21/174 (12.1%)		20/158 (12.7%)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	18/235 (7.7%)		15/227 (6.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	15/217 (6.9%)		11/211 (5.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/259 (0%)		0/255 (0%)		0/0 (NaN)		0/0 (NaN)		0/166 (0%)		0/152 (0%)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/232 (0%)		0/223 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/214 (0%)		0/208 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	75/266 (28.2%)		99/272 (36.4%)		0/0 (NaN)		0/0 (NaN)		93/196 (47.4%)		103/184 (56%)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	85/247 (34.4%)		118/252 (46.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	83/238 (34.9%)		92/231 (39.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Mild)	72/265 (27.2%)		98/271 (36.2%)		0/0 (NaN)		0/0 (NaN)		85/191 (44.5%)		95/180 (52.8%)		0/0 (NaN)		0/0 (NaN)
Erythema (Mild)	83/247 (33.6%)		114/250 (45.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Mild)	81/237 (34.2%)		89/229 (38.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	5/260 (1.9%)		4/256 (1.6%)		0/0 (NaN)		0/0 (NaN)		20/173 (11.6%)		24/158 (15.2%)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	4/232 (1.7%)		8/224 (3.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	10/217 (4.6%)		5/210 (2.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/259 (0%)		0/255 (0%)		0/0 (NaN)		0/0 (NaN)		0/166 (0%)		1/153 (0.7%)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/232 (0%)		0/222 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/214 (0%)		0/208 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

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

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00366340

Other Study ID Numbers:

6096A1-006

First Posted:

Aug 21, 2006

Last Update Posted:

Aug 8, 2012

Last Verified:

Jun 1, 2012

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

Study Details

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Outcome Measure Data

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Statistical Analysis 3

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