13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01964716
• Collaborator: (none)
• Enrollment: 500
• Locations: 2
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 250
• Patients Per Site Per Month: 31.3

Study Details

Study Description

Brief Summary

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multidose Vial Group Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL	Biological: 13-valent pneumococcal conjugate vaccine; Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Active Comparator: Single-Dose Syringe Group Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL	Biological: 13-valent pneumococcal conjugate vaccine; Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group [1 month after the infant series]

   Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.

2. Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group [1 month after the infant series]

   Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.

3. Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group [Within 5 days after Dose 1(Day 2 to Day 6) of the infant series]

   Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.

4. Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group [Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series]

   Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.

5. Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group [Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series]

   Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.

6. Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group [Within 5 days after Dose 1 (Day 2 to Day 6) of infant series]

   Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.

7. Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group [Within 5 days after Dose 2 (Day 2 to Day 6) of infant series]

   Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.

8. Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group [Within 5 days after Dose 3 (Day 2 to Day 6) of infant series]

   Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.

9. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series [Dose 1 up to 28 to 42 days after dose 3]

   An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state

10. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 [Informed consent up to Dose 1]

    An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.

Secondary Outcome Measures

1. Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series [1 month after the infant series]

   Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.

2. Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series [1 month after the infant series]

   Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Days to 70 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 42 to 70 days at enrollment.

• Determined by medical history, physical examination, and clinical judgment to be eligible for the study

• Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal vaccine.

• A previous anaphylactic reaction to any vaccine or vaccine-related component.

• Contraindication to vaccination with pneumococcal conjugate vaccine.

• Receipt of blood products or gamma-globulin since birth

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Council Unit, The Gambia	Fajara	The Gambia, West Africa	Gambia	000273
2	Fajikunda Major Health Centre	Ksmd	The Gambia	Gambia

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01964716
• Other Study ID Numbers: B4671001; 2012-000482-21
• First Posted: Oct 17, 2013
• Last Update Posted: Mar 13, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Pfizer: Prevenar 13; 13vPnC; Healthy Subjects
• Additional relevant MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Pre-assignment Detail	Total number of participants screened were 526, out of which 500 were enrolled in the study. The study was conducted in Gambia which started on 09 January 2014 and completed on 01 September 2014.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Period Title: Overall Study
STARTED	250	250
Vaccinated Dose 1	250	250
Vaccinated Dose 2	249	248
Vaccinated Dose 3	247	244
COMPLETED	245	244
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)	Total
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.	Total of all reporting groups
Overall Participants	250	250	500
Age (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	57.3 (8.6)	56.9 (8.8)	57.1 (8.7)
Sex: Female, Male (Count of Participants)
Female	129 51.6%	130 52%	259 51.8%
Male	121 48.4%	120 48%	241 48.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Description	Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	245	244
Serotype 1 (n=245,244)	99.2 39.7%	100.0 40%
Serotype 3 (n=245,243)	98.8 39.5%	99.6 39.8%
Serotype 4 (n=245,244)	99.6 39.8%	99.6 39.8%
Serotype 5 (n=245,244)	95.9 38.4%	97.1 38.8%
Serotype 6A (n=243,244)	96.3 38.5%	97.5 39%
Serotype 6B (n=245,244)	95.1 38%	95.1 38%
Serotype 7F (n=245,244)	99.6 39.8%	100.0 40%
Serotype 9V (n=245,244)	98.0 39.2%	98.4 39.4%
Serotype 14 (n=245,244)	97.6 39%	98.4 39.4%
Serotype 18C (n=245,244)	99.2 39.7%	98.0 39.2%
Serotype 19A (n=245,244)	99.6 39.8%	98.8 39.5%
Serotype 19F (n=245,244)	96.7 38.7%	97.1 38.8%
Serotype 23F (n=245,244)	95.9 38.4%	95.9 38.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 97.5%; -3.4 to 1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 97.5%; -3.7 to 1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 97.5%; -2.3 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 97.5%; -5.4 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 97.5%; -5.3 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 97.5%; -4.7 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 97.5%; -2.7 to 1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 97.5%; -3.8 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 97.5%; -4.3 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 97.5%; -1.6 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 97.5%; -1.6 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19F: Exact 2-sided confidence interval (based on Chan & Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 97.5%; -4.4 to 3.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 97.5%; -4.3 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Description	Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	245	244
Serotype 1 (n=245,244)	4.59	4.45
Serotype 3 (n=245,243)	1.38	1.74
Serotype 4 (n=245,244)	5.30	5.28
Serotype 5 (n=245,244)	2.00	1.98
Serotype 6A (n=243,244)	2.25	2.19
Serotype 6B (n=245,244)	3.42	3.24
Serotype 7F (n=245,244)	3.92	4.18
Serotype 9V (n=245,244)	2.83	2.75
Serotype 14 (n=245,244)	4.78	4.96
Serotype 18C (n=245,244)	3.47	2.72
Serotype 19A (n=245,244)	6.49	6.44
Serotype 19F (n=245,244)	5.19	5.00
Serotype 23F (n=245,244)	2.61	2.17

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 97.5%; 0.87 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 97.5%; 0.71 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 97.5%; 0.86 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 97.5%; 0.85 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 97.5%; 0.86 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 97.5%; 0.82 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 97.5%; 0.82 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 97.5%; 0.87 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 97.5%; 0.75 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.28
	Confidence Interval	(2-Sided) 97.5%; 1.09 to 1.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 97.5%; 0.82 to 1.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 97.5%; 0.85 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC Ratio
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 97.5%; 0.98 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Description	Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame	Within 5 days after Dose 1(Day 2 to Day 6) of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	248	250
Redness: Any	1 0.4%	0 0%
Redness: Mild	1 0.4%	0 0%
Redness: Moderate	0 0%	0 0%
Redness: Severe	0 0%	0 0%
Swelling: Any	1 0.4%	0 0%
Swelling: Mild	1 0.4%	0 0%
Swelling: Moderate	0 0%	0 0%
Swelling: Severe	0 0%	0 0%
Tenderness: Any	42 16.8%	47 18.8%
Tenderness: Mild	32 12.8%	37 14.8%
Tenderness: Moderate	13 5.2%	14 5.6%
Tenderness: Severe	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Description	Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame	Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days and 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	248	247
Redness: Any (n=247, 247)	2 0.8%	0 0%
Redness: Mild (n=247, 247)	2 0.8%	0 0%
Redness: Moderate (n=247, 247)	0 0%	0 0%
Redness: Severe (n=247, 247)	0 0%	0 0%
Swelling: Any (n=247, 247)	2 0.8%	0 0%
Swelling: Mild (n=247, 247)	2 0.8%	0 0%
Swelling: Moderate (n=247, 247)	1 0.4%	0 0%
Swelling: Severe (n=247, 247)	0 0%	0 0%
Tenderness: Any (n=248, 247)	34 13.6%	32 12.8%
Tenderness: Mild (n=248, 247)	27 10.8%	28 11.2%
Tenderness: Moderate (n=247, 247)	7 2.8%	5 2%
Tenderness: Severe (n=247, 247)	0 0%	0 0%

5. Primary Outcome

Title	Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Description	Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Time Frame	Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	246	241
Redness: Any	0 0%	0 0%
Redness: Mild	0 0%	0 0%
Redness: Moderate	0 0%	0 0%
Redness: Severe	0 0%	0 0%
Swelling: Any	0 0%	0 0%
Swelling: Mild	0 0%	0 0%
Swelling: Moderate	0 0%	0 0%
Swelling: Severe	0 0%	0 0%
Tenderness: Any	37 14.8%	35 14%
Tenderness: Mild	30 12%	32 12.8%
Tenderness: Moderate	9 3.6%	4 1.6%
Tenderness: Severe	0 0%	0 0%

6. Primary Outcome

Title	Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Description	Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 5 days after Dose 1 (Day 2 to Day 6) of infant series

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	249	250
Fever: >=38.0 degree C (n=248, 250)	9 3.6%	7 2.8%
Fever: >=38.0 but <=39.0 degrees C (n=248, 250)	9 3.6%	7 2.8%
Fever: >39.0 but <=40.0 degrees C (n=248, 250)	0 0%	0 0%
Fever: >40.0 degrees C (n=248, 250)	0 0%	0 0%
Decreased appetite: Any (n=248, 250)	17 6.8%	26 10.4%
Decreased appetite: Moderate (n=248, 250)	17 6.8%	26 10.4%
Decreased appetite: Severe (n=248, 250)	0 0%	0 0%
Irritability: Any (n=249, 250)	103 41.2%	93 37.2%
Irritability: Mild (n=249, 250)	86 34.4%	77 30.8%
Irritability: Moderate (n=248, 250)	19 7.6%	17 6.8%
Irritability: Severe (n=248, 250)	0 0%	0 0%
Increased sleep: Any (n=248, 250)	16 6.4%	14 5.6%
Increased sleep: Mild (n=248, 250)	11 4.4%	10 4%
Increased sleep: Moderate (n=248, 250)	6 2.4%	4 1.6%
Increased sleep: Severe (n=248, 250)	0 0%	0 0%
Use of antipyretic medication (n=248, 250)	55 22%	58 23.2%

7. Primary Outcome

Title	Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Description	Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 5 days after Dose 2 (Day 2 to Day 6) of infant series

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	248	247
Fever: >=38.0 degree C (n=247, 247)	7 2.8%	7 2.8%
Fever: >=38.0 but <=39.0 degrees C (n=247, 247)	7 2.8%	7 2.8%
Fever: >39.0 but <=40.0 degrees C (n=247, 247)	1 0.4%	0 0%
Fever: >40.0 degrees C (n=247, 247)	0 0%	0 0%
Decreased appetite: Any(n=247, 247)	28 11.2%	18 7.2%
Decreased appetite: Moderate (n=247, 247)	28 11.2%	18 7.2%
Decreased appetite: Severe (n=247, 247)	0 0%	0 0%
Irritability: Any (n=248, 247)	93 37.2%	83 33.2%
Irritability: Mild (n=248, 247)	75 30%	67 26.8%
Irritability: Moderate (n=247, 247)	23 9.2%	17 6.8%
Irritability: Severe (n=247, 247)	0 0%	3 1.2%
Increased sleep: Any (n=247, 247)	24 9.6%	14 5.6%
Increased sleep: Mild (n=247, 247)	20 8%	12 4.8%
Increased sleep: Moderate (n=247, 247)	4 1.6%	1 0.4%
Increased sleep: Severe (n=247, 247)	0 0%	1 0.4%
Use of antipyretic medication (n=248, 247)	46 18.4%	43 17.2%

8. Primary Outcome

Title	Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Description	Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 5 days after Dose 3 (Day 2 to Day 6) of infant series

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	246	243
Fever: >=38.0 degree C (n=246, 241)	3 1.2%	8 3.2%
Fever: >=38.0 but <=39.0 degrees C (n=246, 241)	3 1.2%	7 2.8%
Fever: >39.0 but <=40.0 degrees C (n=246, 241)	0 0%	1 0.4%
Fever: >40.0 degrees C (n=246, 241)	0 0%	0 0%
Decreased appetite: Any (n=246, 242)	24 9.6%	20 8%
Decreased appetite: Moderate (n=246, 242)	24 9.6%	19 7.6%
Decreased appetite: Severe (n=246, 241)	0 0%	1 0.4%
Irritability: Any (n=246, 243)	83 33.2%	92 36.8%
Irritability: Mild (n=246, 242)	71 28.4%	74 29.6%
Irritability: Moderate (n=246, 242)	15 6%	18 7.2%
Irritability: Severe (n=246, 241)	1 0.4%	5 2%
Increased sleep: Any (n=246, 241)	12 4.8%	12 4.8%
Increased sleep: Mild (n=246, 241)	10 4%	11 4.4%
Increased sleep: Moderate (n=246, 241)	2 0.8%	1 0.4%
Increased sleep: Severe (n=246, 241)	1 0.4%	0 0%
Use of antipyretic medication (n=246, 241)	34 13.6%	36 14.4%

9. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
Description	An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
Time Frame	Dose 1 up to 28 to 42 days after dose 3

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	250	250
AEs	123 49.2%	127 50.8%
SAEs	1 0.4%	0 0%

10. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
Description	An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.
Time Frame	Informed consent up to Dose 1

Outcome Measure Data

Analysis Population Description

Safety population: participants who received at least 1 dose of study vaccine. Here "N"= participants evaluable for this outcome measure.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)	Screened Only
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.	Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
Measure Participants	250	250	26
AEs	2 0.8%	0 0%	9 1.8%
SAEs	0 0%	0 0%	0 0%

11. Secondary Outcome

Title	Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Description	Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	160	160
Serotype 1 (n=159,160)	71.7 28.7%	79.4 31.8%
Serotype 3 (n=160,160)	98.8 39.5%	100.0 40%
Serotype 4 (n=159,159)	100.0 40%	100.0 40%
Serotype 5 (n=160,159)	83.1 33.2%	85.5 34.2%
Serotype 6A (n=160,160)	99.4 39.8%	99.4 39.8%
Serotype 6B (n=156,155)	96.8 38.7%	96.8 38.7%
Serotype 7F (n=159,160)	100.0 40%	100.0 40%
Serotype 9V (n=158,160)	79.7 31.9%	75.0 30%
Serotype 14 (n=157,160)	81.5 32.6%	89.4 35.8%
Serotype 18C (n=159,160)	99.4 39.8%	99.4 39.8%
Serotype 19A (n=160,160)	95.6 38.2%	97.5 39%
Serotype 19F (n=158,159)	93.7 37.5%	94.3 37.7%
Serotype 23F (n=159,160)	96.2 38.5%	97.5 39%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-7.7
	Confidence Interval	(2-Sided) 95%; -17.2 to 1.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95%; -4.4 to 1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.3 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -10.6 to 5.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.9 to 2.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -4.5 to 4.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.3 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	4.7
	Confidence Interval	(2-Sided) 95%; -4.5 to 14.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-7.8
	Confidence Interval	(2-Sided) 95%; -15.8 to -0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.0
	Confidence Interval	(2-Sided) 95%; -2.9 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95%; -6.6 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -6.3 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -5.8 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Description	Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.

Arm/Group Title	13vPnC Multi-dose Vial (MDV)	13vPnC Single-Dose Syringe (SDS)
Arm/Group Description	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.	Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
Measure Participants	160	160
Serotype 1 (n=159,160)	48	52
Serotype 3 (n=160,160)	97	122
Serotype 4 (n=159,159)	1666	1492
Serotype 5 (n=160,159)	79	80
Serotype 6A (n=160,160)	1690	1968
Serotype 6B (n=156,155)	1990	2014
Serotype 7F (n=159,160)	2891	3450
Serotype 9V (n=158,160)	709	706
Serotype 14 (n=157,160)	567	786
Serotype 18C (n=159,160)	2792	1605
Serotype 19A (n=160,160)	305	329
Serotype 19F (n=158,159)	430	470
Serotype 23F (n=159,160)	918	998

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.80 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; 0.48 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 1.38 to 2.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	13vPnC Multi-dose Vial (MDV), 13vPnC Single-Dose Syringe (SDS)
	Comments	Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMT Ratio
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
Adverse Event Reporting Description	SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
Arm/Group Title	13vPnC MDV: Informed Consent to Dose 1		13vPnC SDS: Informed Consent to Dose 1		13vPnC MDV: After Dose 1		13vPnC SDS: After Dose 1		13vPnC MDV: After Dose 2		13vPnC SDS: After Dose 2		13vPnC MDV: After Dose 3		13vPnC SDS: After Dose 3		Screened Only
Arm/Group Description	Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.		Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.		Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.		Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.		Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.		Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.		Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.		Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.		Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
All Cause Mortality
	13vPnC MDV: Informed Consent to Dose 1		13vPnC SDS: Informed Consent to Dose 1		13vPnC MDV: After Dose 1		13vPnC SDS: After Dose 1		13vPnC MDV: After Dose 2		13vPnC SDS: After Dose 2		13vPnC MDV: After Dose 3		13vPnC SDS: After Dose 3		Screened Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	13vPnC MDV: Informed Consent to Dose 1		13vPnC SDS: Informed Consent to Dose 1		13vPnC MDV: After Dose 1		13vPnC SDS: After Dose 1		13vPnC MDV: After Dose 2		13vPnC SDS: After Dose 2		13vPnC MDV: After Dose 3		13vPnC SDS: After Dose 3		Screened Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
General disorders
Sudden infant death syndrome	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	13vPnC MDV: Informed Consent to Dose 1		13vPnC SDS: Informed Consent to Dose 1		13vPnC MDV: After Dose 1		13vPnC SDS: After Dose 1		13vPnC MDV: After Dose 2		13vPnC SDS: After Dose 2		13vPnC MDV: After Dose 3		13vPnC SDS: After Dose 3		Screened Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/250 (0.8%)		0/250 (0%)		113/250 (45.2%)		107/250 (42.8%)		114/249 (45.8%)		99/248 (39.9%)		97/247 (39.3%)		102/244 (41.8%)		9/26 (34.6%)
Congenital, familial and genetic disorders
Heart disease congenital	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		1/26 (3.8%)
Gastrointestinal disorders
Vomiting	0/250 (0%)		0/250 (0%)		3/250 (1.2%)		1/250 (0.4%)		0/249 (0%)		1/248 (0.4%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Abdominal pain	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
General disorders
Pyrexia	0/250 (0%)		0/250 (0%)		0/250 (0%)		2/250 (0.8%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		1/244 (0.4%)		0/26 (0%)
Vaccination site swelling	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Ulcer	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		1/248 (0.4%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Fever: >=38.0 degree C	0/0 (NaN)		0/0 (NaN)		9/248 (3.6%)		7/250 (2.8%)		7/247 (2.8%)		7/247 (2.8%)		3/246 (1.2%)		8/241 (3.3%)		0/26 (0%)
Fever: >=38.0 but <=39.0 degrees C	0/0 (NaN)		0/0 (NaN)		9/248 (3.6%)		7/250 (2.8%)		7/247 (2.8%)		7/247 (2.8%)		3/246 (1.2%)		7/241 (2.9%)		0/26 (0%)
Fever: >39.0 but <=40.0 degrees C	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		1/247 (0.4%)		0/247 (0%)		0/246 (0%)		1/241 (0.4%)		0/26 (0%)
Fever: >40.0 degrees C	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Decreased appetite: Any	0/0 (NaN)		0/0 (NaN)		17/248 (6.9%)		26/250 (10.4%)		28/247 (11.3%)		18/247 (7.3%)		24/246 (9.8%)		20/242 (8.3%)		0/26 (0%)
Decreased appetite: Moderate	0/0 (NaN)		0/0 (NaN)		17/248 (6.9%)		26/250 (10.4%)		28/247 (11.3%)		18/247 (7.3%)		24/246 (9.8%)		19/242 (7.9%)		0/26 (0%)
Decreased appetite: Severe	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		0/247 (0%)		0/246 (0%)		1/241 (0.4%)		0/26 (0%)
Irritability: Any	0/0 (NaN)		0/0 (NaN)		103/249 (41.4%)		93/250 (37.2%)		93/248 (37.5%)		83/247 (33.6%)		83/246 (33.7%)		92/243 (37.9%)		0/26 (0%)
Irritability: Mild	0/0 (NaN)		0/0 (NaN)		86/249 (34.5%)		77/250 (30.8%)		75/248 (30.2%)		67/247 (27.1%)		71/246 (28.9%)		74/242 (30.6%)		0/26 (0%)
Irritability: Moderate	0/0 (NaN)		0/0 (NaN)		19/248 (7.7%)		17/250 (6.8%)		23/247 (9.3%)		17/247 (6.9%)		15/246 (6.1%)		18/242 (7.4%)		0/26 (0%)
Irritability: Severe	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		3/247 (1.2%)		1/246 (0.4%)		5/241 (2.1%)		0/26 (0%)
Increased sleep: Any	0/0 (NaN)		0/0 (NaN)		16/248 (6.5%)		14/250 (5.6%)		24/247 (9.7%)		14/247 (5.7%)		12/246 (4.9%)		12/241 (5%)		0/26 (0%)
Increased sleep: Mild	0/0 (NaN)		0/0 (NaN)		11/248 (4.4%)		10/250 (4%)		20/247 (8.1%)		12/247 (4.9%)		10/246 (4.1%)		11/241 (4.6%)		0/26 (0%)
Increased sleep: Moderate	0/0 (NaN)		0/0 (NaN)		6/248 (2.4%)		4/250 (1.6%)		4/247 (1.6%)		1/247 (0.4%)		2/246 (0.8%)		1/241 (0.4%)		0/26 (0%)
Increased sleep: Severe	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		1/247 (0.4%)		1/246 (0.4%)		0/241 (0%)		0/26 (0%)
Infections and infestations
Bronchopneumonia	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		1/248 (0.4%)		1/247 (0.4%)		4/244 (1.6%)		2/26 (7.7%)
Conjunctivitis	0/250 (0%)		0/250 (0%)		3/250 (1.2%)		3/250 (1.2%)		3/249 (1.2%)		1/248 (0.4%)		4/247 (1.6%)		3/244 (1.2%)		1/26 (3.8%)
Upper respiratory tract infection	1/250 (0.4%)		0/250 (0%)		27/250 (10.8%)		17/250 (6.8%)		17/249 (6.8%)		10/248 (4%)		19/247 (7.7%)		25/244 (10.2%)		0/26 (0%)
Viral diarrhoea	0/250 (0%)		0/250 (0%)		6/250 (2.4%)		10/250 (4%)		8/249 (3.2%)		10/248 (4%)		5/247 (2%)		10/244 (4.1%)		0/26 (0%)
Tinea capitis	0/250 (0%)		0/250 (0%)		4/250 (1.6%)		3/250 (1.2%)		3/249 (1.2%)		1/248 (0.4%)		2/247 (0.8%)		1/244 (0.4%)		0/26 (0%)
Viral infection	0/250 (0%)		0/250 (0%)		3/250 (1.2%)		1/250 (0.4%)		1/249 (0.4%)		3/248 (1.2%)		0/247 (0%)		4/244 (1.6%)		0/26 (0%)
Otitis media	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		2/250 (0.8%)		2/249 (0.8%)		1/248 (0.4%)		3/247 (1.2%)		2/244 (0.8%)		0/26 (0%)
Breast abscess	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)	0
Dysentery	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Gastroenteritis	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		1/244 (0.4%)		0/26 (0%)
Injection site abscess	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Oral candidiasis	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Otitis media acute	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Respiratory tract infection	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		1/249 (0.4%)		3/248 (1.2%)		6/247 (2.4%)		3/244 (1.2%)		0/26 (0%)
Tinea infection	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Tinea versicolour	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Rash pustular	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Tinea faciei	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Furuncle	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		3/247 (1.2%)		0/244 (0%)		0/26 (0%)
Impetigo	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		2/247 (0.8%)		1/244 (0.4%)		0/26 (0%)
Gastroenteritis viral	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		1/244 (0.4%)		0/26 (0%)
Pneumonia	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		2/244 (0.8%)		0/26 (0%)
Atypical pneumonia	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)	0
Chest wall abscess	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Varicella	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Urinary tract infection	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		1/26 (3.8%)
Injury, poisoning and procedural complications
Burns first degree	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		1/244 (0.4%)		0/26 (0%)
Contusion	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Fall	0/250 (0%)		0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Metabolism and nutrition disorders
Failure to thrive	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		1/244 (0.4%)		3/26 (11.5%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		0/244 (0%)		0/26 (0%)
Growth retardation	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		1/26 (3.8%)
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma	0/250 (0%)		0/250 (0%)		2/250 (0.8%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/250 (0%)		0/250 (0%)		2/250 (0.8%)		2/250 (0.8%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Bronchial hyperreactivity	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		1/249 (0.4%)		0/248 (0%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	1/250 (0.4%)		0/250 (0%)		8/250 (3.2%)		12/250 (4.8%)		5/249 (2%)		7/248 (2.8%)		2/247 (0.8%)		6/244 (2.5%)		0/26 (0%)
Dermatitis diaper	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		1/247 (0.4%)		2/244 (0.8%)		0/26 (0%)
Eczema	0/250 (0%)		0/250 (0%)		1/250 (0.4%)		0/250 (0%)		1/249 (0.4%)		1/248 (0.4%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Dermatitis atopic	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		1/248 (0.4%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Rash papular	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		1/248 (0.4%)		0/247 (0%)		0/244 (0%)		0/26 (0%)
Skin ulcer	0/250 (0%)		0/250 (0%)		0/250 (0%)		0/250 (0%)		0/249 (0%)		0/248 (0%)		0/247 (0%)		1/244 (0.4%)		0/26 (0%)
Redness: Any	0/0 (NaN)		0/0 (NaN)		1/248 (0.4%)		0/250 (0%)		2/247 (0.8%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Redness: Mild	0/0 (NaN)		0/0 (NaN)		1/248 (0.4%)		0/250 (0%)		2/247 (0.8%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Redness: Moderate	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Redness: Severe	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Swelling: Any	0/0 (NaN)		0/0 (NaN)		1/248 (0.4%)		0/250 (0%)		2/247 (0.8%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Swelling: Mild	0/0 (NaN)		0/0 (NaN)		1/248 (0.4%)		0/250 (0%)		2/247 (0.8%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Swelling: Moderate	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		1/247 (0.4%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Swelling: Severe	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)
Tenderness: Any	0/0 (NaN)		0/0 (NaN)		42/248 (16.9%)		47/250 (18.8%)		34/248 (13.7%)		32/247 (13%)		37/246 (15%)		35/241 (14.5%)		0/26 (0%)
Tenderness: Mild	0/0 (NaN)		0/0 (NaN)		32/248 (12.9%)		37/250 (14.8%)		27/248 (10.9%)		28/247 (11.3%)		30/246 (12.2%)		32/241 (13.3%)		0/26 (0%)
Tenderness: Moderate	0/0 (NaN)		0/0 (NaN)		13/248 (5.2%)		14/250 (5.6%)		7/247 (2.8%)		5/247 (2%)		9/246 (3.7%)		4/241 (1.7%)		0/26 (0%)
Tenderness: Severe	0/0 (NaN)		0/0 (NaN)		0/248 (0%)		0/250 (0%)		0/247 (0%)		0/247 (0%)		0/246 (0%)		0/241 (0%)		0/26 (0%)

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.