A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01250756
• Collaborator: (none)
• Enrollment: 321
• Locations: 18
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 17.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Biological: 7-pneumococcal conjugate vaccine (7vPnC); Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP); Biological: DTaP	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 321 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Experimental	Biological: 7-pneumococcal conjugate vaccine (7vPnC); 0.5 mL per dose, 4 doses; Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP); 0.5 mL per dose, 4 doses
Experimental: 2 Active comparator	Biological: DTaP; 0.5 mL per dose, 4 doses

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series [1 month after the infant series]

   Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).

2. Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series [1 month after the infant series]

   Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.

3. Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series [1 month after the infant series]

   GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

4. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series [1 month after the infant series]

   Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

5. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series [1 month after the infant series]

   Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Secondary Outcome Measures

1. Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose [1 month after the toddler dose]

   Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.

2. Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose [1 month after the toddler dose]

   GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.

3. Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose [1 month after the toddler dose]

   GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

4. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose [1 month after the toddler dose]

   Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

5. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose [1 month after the toddler dose]

   Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

6. Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose [Pre-toddler dose, 1 month after the toddler dose]

   Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

7. Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 [1 month after the catch-up dose 3]

   Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

8. Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 [1 month after the catch-up dose 3]

   Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

Other Outcome Measures

1. Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) [Within 7 days after Dose 1 of the infant series]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

2. Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) [Within 7 days after Dose 2 of the infant series]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

3. Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) [Within 7 days after Dose 3 of the infant series]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

4. Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) [Within 7 days after the toddler dose]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

5. Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) [Within 7 days after Catch-up Dose 1]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

6. Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) [Within 7 days after Catch-up Dose 2]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

7. Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) [Within 7 days after Catch-up Dose 3]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

8. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) [Within 7 days after Dose 1 of the infant series]

   Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

9. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) [Within 7 days after Dose 2 of the infant series]

   Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

10. Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) [Within 7 days after Dose 3 of the infant series]

    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

11. Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) [Within 7 days after the toddler dose]

    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

12. Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) [Within 7 days after Catch-up Dose 1]

    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

13. Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) [Within 7 days after Catch-up Dose 2]

    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

14. Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) [Within 7 days after Catch-up Dose 3]

    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.

• Available for entire study period and whose parent/legal guardian can be reached by telephone.

• Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.

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

• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.

• History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).

• Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sotobo Children's Clinic	Isumi-city	Chiba	Japan
2	Matsuyama Red Cross Hospital	Matsuyama-city	Ehime	Japan
3	Yamashita Pediatrics Clinic	Itoshima	Fukuoka	Japan
4	Yokoyama Children's Clinic	Kasuga	Fukuoka	Japan
5	Tenshi Hospital	Sapporo-city	Hokkaido	Japan
6	Furuta Children's Clinic	Sapporo	Hokkaido	Japan
7	Watanabe Pediatric Allergy Clinic	Sapporo	Hokkaido	Japan
8	Yamanaka Tatsuru Pediatrics	Sapporo	Hokkaido	Japan
9	Matsuda Pediatrics Clinic	Kuwana	Mie	Japan
10	Kawasaki Medical School, Department of Pediatrics	Kurashiki	Okayama	Japan
11	Momotaro Clinic	Okayama-city	Okayama	Japan
12	Hug Hug Kids Clinic	Toyonaka	Osaka	Japan
13	Shibuya Clinic	Kumagaya-city	Saitama	Japan
14	Tsubaki Children's Clinic	Chiba		Japan
15	Kiyomatsu Childrens Clinic	Fukuoka		Japan
16	National Hospital Organization Fukuoka National Hospital	Fukuoka		Japan
17	Shindo Children's Clinic	Fukuoka		Japan
18	Takasaki Clinic Pedatrics and Child Health	Fukuoka		Japan

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: NCT01250756
• Other Study ID Numbers: B1841007; B1841007, 6107A1-4000
• First Posted: Dec 1, 2010
• Last Update Posted: Feb 26, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Pfizer: vaccine; pneumococcal conjugate
• Additional relevant MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Period Title: Infant Series
STARTED	161	160
Vaccinated Dose 1	159	158
Vaccinated Dose 2	147	157
Vaccinated Dose 3	133	155
COMPLETED	133	153
NOT COMPLETED	28	7
Period Title: Infant Series
STARTED	133	153
COMPLETED	122	149
NOT COMPLETED	11	4
Period Title: Infant Series
STARTED	122	149
COMPLETED	122	148
NOT COMPLETED	0	1
Period Title: Infant Series
STARTED	0	148
COMPLETED	0	147
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)	Total
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.	Total of all reporting groups
Overall Participants	161	160	321
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	3.8 (0.91)	3.9 (0.94)	3.9 (0.93)
Sex: Female, Male (Count of Participants)
Female	80 49.7%	82 51.3%	162 50.5%
Male	81 50.3%	78 48.8%	159 49.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Description	Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	132	149
Diphtheria	100.0 62.1%	100.0 62.5%
Tetanus	100.0 62.1%	100.0 62.5%
Pertussis toxoid (PT)	100.0 62.1%	100.0 62.5%
Filamentous hemagglutinin (FHA)	100.0 62.1%	100.0 62.5%

2. Primary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Description	Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	132	149
Diphtheria	1.38	0.99
Tetanus	1.91	2.05

3. Primary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
Description	GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	132	149
Pertussis toxoid (PT)	76.79	83.56
Filamentous hemagglutinin (FHA)	72.89	77.85

4. Primary Outcome

Title	Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Description	Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Measure Participants	132
4	100.0 62.1%
6B	99.2 61.6%
9V	100.0 62.1%
14	99.2 61.6%
18C	99.2 61.6%
19F	97.7 60.7%
23F	98.5 61.2%

5. Primary Outcome

Title	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Description	Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time Frame	1 month after the infant series

Outcome Measure Data

Analysis Population Description

Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Measure Participants	132
4	11.82
6B	4.23
9V	5.96
14	16.61
18C	5.48
19F	8.85
23F	4.17

6. Secondary Outcome

Title	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Description	Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	121	146
Diphtheria	100.0 62.1%	100.0 62.5%
Tetanus	100.0 62.1%	100.0 62.5%
Pertussis toxoid (PT)	100.0 62.1%	100.0 62.5%
Filamentous hemagglutinin (FHA)	100.0 62.1%	100.0 62.5%

7. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Description	GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	121	146
Diphtheria	2.56	2.14
Tetanus	2.53	3.04

8. Secondary Outcome

Title	Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
Description	GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	121	146
PT	106.54	130.62
FHA	120.99	145.38

9. Secondary Outcome

Title	Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
Description	Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Measure Participants	121
4	100.0 62.1%
6B	100.0 62.1%
9V	100.0 62.1%
14	100.0 62.1%
18C	99.2 61.6%
19F	99.2 61.6%
23F	100.0 62.1%

10. Secondary Outcome

Title	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Description	Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Time Frame	1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Measure Participants	121
4	12.15
6B	10.66
9V	6.43
14	15.83
18C	6.53
19F	9.70
23F	10.17

11. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Description	Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Time Frame	Pre-toddler dose, 1 month after the toddler dose

Outcome Measure Data

Analysis Population Description

Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	7vPnC + DTaP
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
Measure Participants	121
4	6.74
6B	5.89
9V	4.34
14	3.63
18C	6.90
19F	6.37
23F	8.10

12. Secondary Outcome

Title	Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Description	Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame	1 month after the catch-up dose 3

Outcome Measure Data

Analysis Population Description

Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	148
4	100.0 62.1%
6B	99.3 61.7%
9V	100.0 62.1%
14	100.0 62.1%
18C	99.3 61.7%
19F	100.0 62.1%
23F	99.3 61.7%

13. Secondary Outcome

Title	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Description	Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Time Frame	1 month after the catch-up dose 3

Outcome Measure Data

Analysis Population Description

Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	148
4	6.63
6B	4.30
9V	3.48
14	11.55
18C	3.10
19F	5.16
23F	4.41

14. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after Dose 1 of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	152	154
Erythema-Any (n= 152, 152)	57.2 35.5%	14.5 9.1%
Erythema-Mild (n= 152, 151)	52.6 32.7%	12.6 7.9%
Erythema-Moderate (n= 148, 152)	14.9 9.3%	2.0 1.3%
Erythema-Severe (n= 148, 151)	0.0 0%	0.0 0%
Induration-Any (n= 149, 153)	40.3 25%	7.8 4.9%
Induration-Mild (n= 149, 153)	38.3 23.8%	7.8 4.9%
Induration-Moderate (n= 148, 151)	10.1 6.3%	0.0 0%
Induration-Severe (n= 148, 151)	0.0 0%	0.0 0%
Tenderness-Any (n= 148, 151)	12.2 7.6%	0.7 0.4%
Tenderness-Significant (n= 148, 151)	0.0 0%	0.0 0%
Any local reaction (n= 152, 154)	66.4 41.2%	15.6 9.8%

15. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after Dose 2 of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	143	151
Erythema-Any (n= 142, 150)	64.1 39.8%	39.3 24.6%
Erythema-Mild (n= 142, 150)	58.5 36.3%	33.3 20.8%
Erythema-Moderate (n= 134, 147)	32.1 19.9%	6.8 4.3%
Erythema-Severe (n= 133, 147)	0.0 0%	0.0 0%
Induration-Any (n= 137, 150)	51.8 32.2%	30.0 18.8%
Induration-Mild (n= 137, 150)	49.6 30.8%	28.7 17.9%
Induration-Moderate (n= 134, 148)	23.9 14.8%	6.8 4.3%
Induration-Severe (n= 133, 147)	0.0 0%	0.0 0%
Tenderness-Any (n= 133, 147)	7.5 4.7%	4.1 2.6%
Tenderness-Significant (n= 133, 147)	0.0 0%	0.0 0%
Any local reaction (n= 143, 151)	69.2 43%	45.0 28.1%

16. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after Dose 3 of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	126	145
Erythema-Any (n= 123, 144)	52.8 32.8%	30.6 19.1%
Erythema-Mild (n= 123, 143)	46.3 28.8%	28.0 17.5%
Erythema-Moderate (n= 120, 139)	20.0 12.4%	5.8 3.6%
Erythema-Severe (n= 118, 138)	0.0 0%	0.0 0%
Induration-Any (n= 124, 144)	44.4 27.6%	19.4 12.1%
Induration-Mild (n= 124, 144)	42.7 26.5%	19.4 12.1%
Induration-Moderate (n= 119, 139)	11.8 7.3%	2.2 1.4%
Induration-Severe (n= 118, 138)	0.0 0%	0.0 0%
Tenderness-Any (n= 119, 138)	5.0 3.1%	3.6 2.3%
Tenderness-Significant (n= 118, 138)	0.0 0%	0.0 0%
Any local reaction (n= 126, 145)	61.1 38%	33.1 20.7%

17. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after the toddler dose

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	110	138
Erythema-Any (n= 108, 137)	51.9 32.2%	32.1 20.1%
Erythema-Mild (n= 106, 137)	48.1 29.9%	28.5 17.8%
Erythema-Moderate (n= 102, 134)	23.5 14.6%	7.5 4.7%
Erythema-Severe (n= 98, 133)	0.0 0%	0.0 0%
Induration-Any (n= 108, 137)	42.6 26.5%	23.4 14.6%
Induration-Mild (n= 108, 137)	40.7 25.3%	19.7 12.3%
Induration-Moderate (n= 99, 133)	16.2 10.1%	6.8 4.3%
Induration-Severe (n= 98, 133)	0.0 0%	0.0 0%
Tenderness-Any (n= 99, 136)	11.1 6.9%	4.4 2.8%
Tenderness-Significant (n= 98, 133)	0.0 0%	0.0 0%
Any local reaction (n= 110, 138)	56.4 35%	39.1 24.4%

18. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after Catch-up Dose 1

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	141
Erythema-Any (n= 139)	51.8 32.2%
Erythema-Mild (n= 139)	45.3 28.1%
Erythema-Moderate (n= 136)	10.3 6.4%
Erythema-Severe (n= 135)	0.0 0%
Induration-Any (n= 138)	34.8 21.6%
Induration-Mild (n= 138)	32.6 20.2%
Induration-Moderate (n= 135)	8.1 5%
Induration-Severe (n= 135)	0.0 0%
Tenderness-Any (n= 136)	8.1 5%
Tenderness-Significant (n= 135)	0.0 0%
Any local reaction (n= 141)	54.6 33.9%

19. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after Catch-up Dose 2

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	145
Erythema-Any (n= 144)	50.7 31.5%
Erythema-Mild (n= 144)	45.1 28%
Erythema-Moderate (n= 140)	13.6 8.4%
Erythema-Severe (n= 138)	0.0 0%
Induration-Any (n= 144)	32.6 20.2%
Induration-Mild (n= 143)	30.1 18.7%
Induration-Moderate (n= 140)	15.0 9.3%
Induration-Severe (n= 138)	0.0 0%
Tenderness-Any (n= 139)	5.0 3.1%
Tenderness-Significant (n= 138)	0.0 0%
Any local reaction (n= 145)	55.2 34.3%

20. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
Time Frame	Within 7 days after Catch-up Dose 3

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	137
Erythema-Any (n= 134)	32.1 19.9%
Erythema-Mild (n= 133)	27.1 16.8%
Erythema-Moderate (n= 131)	9.9 6.1%
Erythema-Severe (n= 130)	0.0 0%
Induration-Any (n= 134)	27.6 17.1%
Induration-Mild (n= 133)	24.8 15.4%
Induration-Moderate (n= 131)	9.9 6.1%
Induration-Severe (n= 130)	0.0 0%
Tenderness-Any (n= 132)	6.8 4.2%
Tenderness-Significant (n= 130)	0.0 0%
Any local reaction (n= 137)	40.9 25.4%

21. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after Dose 1 of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	154	153
Fever >=37.5 but =<39 degrees C(n=149,152)	18.8 11.7%	15.8 9.9%
Fever >39 but =<40.0 degrees C(n=148,151)	2.0 1.2%	2.0 1.3%
Fever >40 degrees C(n=148,151)	0.0 0%	0.0 0%
Decreased appetite(n=148,151)	8.8 5.5%	7.9 4.9%
Irritability(n=151,151)	15.2 9.4%	9.3 5.8%
Increased sleep(n=150,153)	32.0 19.9%	25.5 15.9%
Decreased sleep(n=151,151)	16.6 10.3%	15.2 9.5%
Hives (urticaria)(n=148,151)	1.4 0.9%	0.7 0.4%
Antipyretic medication to treat symptom(n=148,151)	1.4 0.9%	1.3 0.8%
Any systemic event(n=154,153)	57.8 35.9%	48.4 30.3%

22. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after Dose 2 of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	142	153
Fever >=37.5 but =<39 degrees C(n=138,149)	25.4 15.8%	15.4 9.6%
Fever >39 but =<40.0 degrees C(n=135,147)	2.2 1.4%	0.0 0%
Fever >40 degrees C(n=133,147)	0.0 0%	0.7 0.4%
Decreased appetite(n=135,147)	11.9 7.4%	5.4 3.4%
Irritability(n=134,149)	19.4 12%	12.1 7.6%
Increased sleep(n=136,148)	19.1 11.9%	12.8 8%
Decreased sleep(n=140,151)	17.1 10.6%	15.2 9.5%
Hives (urticaria)(n=133,147)	3.0 1.9%	0.0 0%
Antipyretic medication to treat symptom(n=134,147)	2.2 1.4%	2.0 1.3%
Any systemic event(n=142,153)	53.5 33.2%	38.6 24.1%

23. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after Dose 3 of the infant series

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	122	143
Fever >=37.5 but =<39 degrees C(n=120,141)	19.2 11.9%	14.9 9.3%
Fever >39 but =<40.0 degrees C(n=118,138)	1.7 1.1%	0.7 0.4%
Fever >40 degrees C(n=118,138)	0.0 0%	0.0 0%
Decreased appetite(n=119,138)	8.4 5.2%	6.5 4.1%
Irritability(n=118,139)	10.2 6.3%	7.2 4.5%
Increased sleep(n=119,141)	16.0 9.9%	18.4 11.5%
Decreased sleep(n=120,140)	6.7 4.2%	14.3 8.9%
Hives (urticaria)(n=119,138)	1.7 1.1%	0.0 0%
Antipyretic medication to treat symptom(n=119,138)	1.7 1.1%	2.2 1.4%
Any systemic event(n=122,143)	39.3 24.4%	36.4 22.8%

24. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after the toddler dose

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.

Arm/Group Title	7vPnC + DTaP	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	108	138
Fever >=37.5 but =<39 degrees C(n=103,135)	34.0 21.1%	22.2 13.9%
Fever >39 but =<40.0 degrees C(n=99,132)	5.1 3.2%	2.3 1.4%
Fever >40 degrees C(n=98,132)	1.0 0.6%	0.0 0%
Decreased appetite(n=100,133)	9.0 5.6%	8.3 5.2%
Irritability(n=100,134)	17.0 10.6%	9.7 6.1%
Increased sleep(n=103,135)	20.4 12.7%	15.6 9.8%
Decreased sleep(n=101,133)	10.9 6.8%	7.5 4.7%
Hives (urticaria)(n=98,133)	1.0 0.6%	0.8 0.5%
Antipyretic medication to treat symptom(n=98,133)	4.1 2.5%	4.5 2.8%
Any systemic event(n=108,138)	52.8 32.8%	39.9 24.9%

25. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after Catch-up Dose 1

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	139
Fever >=37.5 but =<39 degrees C(n=139)	32.4 20.1%
Fever >39 but =<40.0 degrees C(n=135)	2.2 1.4%
Fever >40 degrees C(n=135)	0.0 0%
Decreased appetite(n=136)	8.1 5%
Irritability(n=136)	12.5 7.8%
Increased sleep(n=136)	17.6 10.9%
Decreased sleep(n=136)	11.8 7.3%
Hives (urticaria)(n=135)	0.7 0.4%
Antipyretic medication to treat symptom(n=136)	5.9 3.7%
Any systemic event(n=139)	49.6 30.8%

26. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after Catch-up Dose 2

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	141
Fever >=37.5 but =<39 degrees C(n=140)	32.1 19.9%
Fever >39 but =<40.0 degrees C(n=138)	5.1 3.2%
Fever >40 degrees C(n=138)	0.7 0.4%
Decreased appetite(n=138)	10.9 6.8%
Irritability(n=138)	11.6 7.2%
Increased sleep(n=138)	15.9 9.9%
Decreased sleep(n=139)	10.1 6.3%
Hives (urticaria)(n=138)	2.2 1.4%
Antipyretic medication to treat symptom(n=138)	5.1 3.2%
Any systemic event(n=141)	47.5 29.5%

27. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Description	Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame	Within 7 days after Catch-up Dose 3

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.

Arm/Group Title	DTaP (Catch-up 7vPnC)
Arm/Group Description	Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
Measure Participants	136
Fever >=37.5 but =<39 degrees C(n=134)	26.9 16.7%
Fever >39 but =<40.0 degrees C(n=130)	0.8 0.5%
Fever >40 degrees C(n=130)	0.0 0%
Decreased appetite(n=130)	6.2 3.9%
Irritability(n=131)	9.2 5.7%
Increased sleep(n=131)	10.7 6.6%
Decreased sleep(n=131)	6.9 4.3%
Hives (urticaria)(n=131)	0.8 0.5%
Antipyretic medication to treat symptom(n=130)	1.5 0.9%
Any systemic event(n=136)	39.0 24.2%

Adverse Events

Time Frame	AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 7 days after each vaccine dose).
Adverse Event Reporting Description	Safety population: participants who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
Arm/Group Title	7vPnC + DTaP - Infant Series		DTaP (Catch-up 7vPnC)- Infant Series		7vPnC + DTaP - After the Infant Series		DTaP (Catch-up 7vPnC) - After the Infant Series		7vPnC + DTaP - Toddler Dose		DTaP (Catch-up 7vPnC) - Toddler Dose		DTaP (Catch-up 7vPnC) - After the Toddler Dose
Arm/Group Description	Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.		Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.		Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.		Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.		Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.		Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.		Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
All Cause Mortality
	7vPnC + DTaP - Infant Series		DTaP (Catch-up 7vPnC)- Infant Series		7vPnC + DTaP - After the Infant Series		DTaP (Catch-up 7vPnC) - After the Infant Series		7vPnC + DTaP - Toddler Dose		DTaP (Catch-up 7vPnC) - Toddler Dose		DTaP (Catch-up 7vPnC) - After the Toddler Dose
	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)
Serious Adverse Events
	7vPnC + DTaP - Infant Series		DTaP (Catch-up 7vPnC)- Infant Series		7vPnC + DTaP - After the Infant Series		DTaP (Catch-up 7vPnC) - After the Infant Series		7vPnC + DTaP - Toddler Dose		DTaP (Catch-up 7vPnC) - Toddler Dose		DTaP (Catch-up 7vPnC) - After the Toddler Dose
	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	3/159 (1.9%)		7/158 (4.4%)		10/159 (6.3%)		7/158 (4.4%)		0/122 (0%)		4/149 (2.7%)		1/149 (0.7%)
Congenital, familial and genetic disorders
Cryptorchism	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Gastrointestinal disorders
Inguinal hernia	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Intussusception	0/159 (0%)		1/158 (0.6%)		1/159 (0.6%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
General disorders
Pyrexia	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Infections and infestations
Gastroenteritis viral	1/159 (0.6%)		1/158 (0.6%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Respiratory syncytial virus bronchitis	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Bronchitis bacterial	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Respiratory syncytial virus bronchiolitis	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Bronchitis	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Pneumonia	0/159 (0%)		0/158 (0%)		2/159 (1.3%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Adenovirus infection	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Exanthema subitum	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Gastroenteritis adenovirus	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Otitis media	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Pneumonia mycoplasmal	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Pneumonia respiratory syncytial viral	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Upper respiratory tract infection	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Bronchopneumonia	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		2/149 (1.3%)		0/149 (0%)
Injury, poisoning and procedural complications
Burns second degree	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Metabolism and nutrition disorders
Weight gain poor	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Nervous system disorders
Febrile convulsion	0/159 (0%)		0/158 (0%)		4/159 (2.5%)		2/158 (1.3%)		0/122 (0%)		1/149 (0.7%)		1/149 (0.7%)
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Apnoea	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Tonsillar hypertrophy	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Infantile asthma	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Respiratory failure	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Vascular disorders
Kawasaki's disease	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Other (Not Including Serious) Adverse Events
	7vPnC + DTaP - Infant Series		DTaP (Catch-up 7vPnC)- Infant Series		7vPnC + DTaP - After the Infant Series		DTaP (Catch-up 7vPnC) - After the Infant Series		7vPnC + DTaP - Toddler Dose		DTaP (Catch-up 7vPnC) - Toddler Dose		DTaP (Catch-up 7vPnC) - After the Toddler Dose
	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	123/159 (77.4%)		126/158 (79.7%)		20/159 (12.6%)		129/158 (81.6%)		72/122 (59%)		96/149 (64.4%)		85/149 (57%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/159 (0.6%)		1/158 (0.6%)		2/159 (1.3%)		2/158 (1.3%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Cardiac disorders
Wolff-Parkinson-White syndrome	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Eye disorders
Conjunctivitis	6/159 (3.8%)		14/158 (8.9%)		0/159 (0%)		9/158 (5.7%)		1/122 (0.8%)		4/149 (2.7%)		2/149 (1.3%)
Eye discharge	3/159 (1.9%)		3/158 (1.9%)		0/159 (0%)		2/158 (1.3%)		1/122 (0.8%)		0/149 (0%)		2/149 (1.3%)
Keratitis	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Ocular hyperaemia	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Eyelid oedema	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Gastrointestinal disorders
Constipation	8/159 (5%)		8/158 (5.1%)		0/159 (0%)		6/158 (3.8%)		1/122 (0.8%)		1/149 (0.7%)		0/149 (0%)
Diarrhoea	7/159 (4.4%)		9/158 (5.7%)		1/159 (0.6%)		8/158 (5.1%)		6/122 (4.9%)		6/149 (4%)		2/149 (1.3%)
Haematochezia	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Dyspepsia	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Ileus	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Inguinal hernia	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Intussusception	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Upper gastrointestinal haemorrhage	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Vomiting	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		2/158 (1.3%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Stomatitis	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Aphthous stomatitis	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
General disorders
Vaccination site erythema	5/159 (3.1%)		10/158 (6.3%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Pyrexia	5/159 (3.1%)		0/158 (0%)		0/159 (0%)		4/158 (2.5%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Vaccination site induration	1/159 (0.6%)		4/158 (2.5%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Injection site induration	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Vaccination site swelling	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Application site erythema	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Injection site haemorrhage	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Fever ≥37.5°C but ≤39°C	28/149 (18.8%)		24/152 (15.8%)		0/0 (NaN)		45/139 (32.4%)		35/103 (34%)		30/135 (22.2%)		26/134 (19.4%)
Fever ≥37.5°C but ≤39°C	35/138 (25.4%)		23/149 (15.4%)		0/0 (NaN)		45/140 (32.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever ≥37.5°C but ≤39°C	23/120 (19.2%)		21/141 (14.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever>39°C but ≤40°C	3/148 (2%)		3/135 (2.2%)		0/0 (NaN)		3/135 (2.2%)		5/99 (5.1%)		3/132 (2.3%)		1/130 (0.8%)
Fever>39°C but ≤40°C	3/135 (2.2%)		0/147 (0%)		0/0 (NaN)		7/138 (5.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever>39°C but ≤40°C	2/118 (1.7%)		1/138 (0.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40.0°C	0/148 (0%)		0/151 (0%)		0/0 (NaN)		0/135 (0%)		1/98 (1%)		0/132 (0%)		0/130 (0%)
Fever >40.0°C	0/133 (0%)		1/147 (0.7%)		0/0 (NaN)		1/138 (0.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Fever >40.0°C	0/118 (0%)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	13/148 (8.8%)		12/151 (7.9%)		0/0 (NaN)		11/136 (8.1%)		9/100 (9%)		11/133 (8.3%)		8/130 (6.2%)
Decreased appetite	16/135 (11.9%)		8/147 (5.4%)		0/0 (NaN)		15/138 (10.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased appetite	10/119 (8.4%)		9/138 (6.5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	23/151 (15.2%)		14/151 (9.3%)		0/0 (NaN)		17/136 (12.5%)		17/100 (17%)		13/134 (9.7%)		12/131 (9.2%)
Irritability	26/134 (19.4%)		18/149 (12.1%)		0/0 (NaN)		16/138 (11.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Irritability	12/118 (10.2%)		10/139 (7.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	48/150 (32%)		39/153 (25.5%)		0/0 (NaN)		24/136 (17.6%)		21/103 (20.4%)		21/135 (15.6%)		14/131 (10.7%)
Increased sleep	26/136 (19.1%)		19/148 (12.8%)		0/0 (NaN)		22/138 (15.9%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Increased sleep	19/119 (16%)		26/141 (18.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	25/151 (16.6%)		23/151 (15.2%)		0/0 (NaN)		16/136 (11.8%)		11/101 (10.9%)		10/133 (7.5%)		9/131 (6.9%)
Decreased sleep	24/140 (17.1%)		23/151 (15.2%)		0/0 (NaN)		14/139 (10.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Decreased sleep	8/120 (6.7%)		20/140 (14.3%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hives (urticaria)	2/148 (1.4%)		1/151 (0.7%)		0/0 (NaN)		1/135 (0.7%)		1/98 (1%)		1/133 (0.8%)		1/131 (0.8%)
Hives (urticaria)	4/133 (3%)		0/147 (0%)		0/0 (NaN)		3/138 (2.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Hives (urticaria)	2/119 (1.7%)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Use of antipyretic medication to treat symptoms	2/148 (1.4%)		2/151 (1.3%)		0/0 (NaN)		8/136 (5.9%)		4/98 (4.1%)		6/133 (4.5%)		2/130 (1.5%)
Use of antipyretic medication to treat symptoms	3/134 (2.2%)		3/147 (2%)		0/0 (NaN)		7/138 (5.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Use of antipyretic medication to treat symptoms	2/119 (1.7%)		3/138 (2.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Immune system disorders
Food allergy	2/159 (1.3%)		1/158 (0.6%)		6/159 (3.8%)		6/158 (3.8%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Allergy to arthropod bite	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Milk allergy	0/159 (0%)		1/158 (0.6%)		1/159 (0.6%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Allergy to animal	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Anaphylactic reaction	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Infections and infestations
Nasopharyngitis	49/159 (30.8%)		59/158 (37.3%)		1/159 (0.6%)		63/158 (39.9%)		27/122 (22.1%)		43/149 (28.9%)		42/149 (28.2%)
Upper respiratory tract infection	35/159 (22%)		22/158 (13.9%)		5/159 (3.1%)		27/158 (17.1%)		17/122 (13.9%)		19/149 (12.8%)		10/149 (6.7%)
Gastroenteritis	19/159 (11.9%)		12/158 (7.6%)		0/159 (0%)		13/158 (8.2%)		2/122 (1.6%)		4/149 (2.7%)		8/149 (5.4%)
Influenza	16/159 (10.1%)		12/158 (7.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		1/149 (0.7%)
Bronchitis	10/159 (6.3%)		11/158 (7%)		0/159 (0%)		17/158 (10.8%)		11/122 (9%)		12/149 (8.1%)		9/149 (6%)
Exanthema subitum	6/159 (3.8%)		13/158 (8.2%)		0/159 (0%)		21/158 (13.3%)		2/122 (1.6%)		7/149 (4.7%)		4/149 (2.7%)
Gastroenteritis viral	7/159 (4.4%)		3/158 (1.9%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Varicella	5/159 (3.1%)		3/158 (1.9%)		0/159 (0%)		2/158 (1.3%)		2/122 (1.6%)		3/149 (2%)		2/149 (1.3%)
Impetigo	2/159 (1.3%)		5/158 (3.2%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		1/149 (0.7%)		1/149 (0.7%)
Otitis media	5/159 (3.1%)		2/158 (1.3%)		0/159 (0%)		9/158 (5.7%)		4/122 (3.3%)		2/149 (1.3%)		2/149 (1.3%)
Respiratory syncytial virus infection	2/159 (1.3%)		5/158 (3.2%)		0/159 (0%)		0/158 (0%)		2/122 (1.6%)		0/149 (0%)		0/149 (0%)
Bronchiolitis	5/159 (3.1%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Pharyngitis	1/159 (0.6%)		5/158 (3.2%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		4/149 (2.7%)
Otitis media acute	0/159 (0%)		5/158 (3.2%)		0/159 (0%)		4/158 (2.5%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Enteritis infectious	0/159 (0%)		3/158 (1.9%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Rhinitis	1/159 (0.6%)		2/158 (1.3%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		3/149 (2%)		1/149 (0.7%)
Gastroenteritis rotavirus	2/159 (1.3%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Molluscum contagiosum	0/159 (0%)		2/158 (1.3%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Oral candidiasis	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Otitis externa	2/159 (1.3%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Paronychia	2/159 (1.3%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Respiratory syncytial virus bronchitis	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Tonsillitis	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		1/149 (0.7%)		0/149 (0%)
Adenovirus infection	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Cellulitis	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Conjunctivitis viral	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Croup infectious	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Fungal infection	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Fungal skin infection	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Genital candidiasis	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Hand-foot-and-mouth disease	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		11/158 (7%)		4/122 (3.3%)		6/149 (4%)		2/149 (1.3%)
Hordeolum	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Mucocutaneous candidiasis	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Respiratory tract infection	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Rotavirus infection	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Sinusitis	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Staphylococcal scalded skin syndrome	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Vaccination site infection	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Viral infection	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Viral rash	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		1/149 (0.7%)		0/149 (0%)
Gastroenteritis bacterial	0/159 (0%)		0/158 (0%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Candidiasis	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Conjunctivitis bacterial	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Herpangina	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		0/149 (0%)		1/149 (0.7%)
Herpes simplex	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Localised infection	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Otitis media bacterial	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Bronchopneumonia	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Candida nappy rash	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Acute sinusitis	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Gastroenteritis adenovirus	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Injury, poisoning and procedural complications
Excoriation	0/159 (0%)		2/158 (1.3%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Contusion	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		3/149 (2%)		1/149 (0.7%)
Joint dislocation	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Thermal burn	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		1/122 (0.8%)		1/149 (0.7%)		2/149 (1.3%)
Arthropod bite	0/159 (0%)		0/158 (0%)		0/159 (0%)		4/158 (2.5%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Wound	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Arthropod sting	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		1/149 (0.7%)
Face injury	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Fall	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Lip injury	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Investigations
Alanine aminotransferase increased	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Aspartate aminotransferase increased	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Blood lactate dehydrogenase increased	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Metabolism and nutrition disorders
Lactose intolerance	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Reproductive system and breast disorders
Genital rash	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic	1/159 (0.6%)		1/158 (0.6%)		1/159 (0.6%)		3/158 (1.9%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Rhinorrhoea	1/159 (0.6%)		1/158 (0.6%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Asthma	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		1/149 (0.7%)
Infantile asthma	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Rhinitis perennial	0/159 (0%)		0/158 (0%)		1/159 (0.6%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Skin and subcutaneous tissue disorders
Eczema	26/159 (16.4%)		22/158 (13.9%)		2/159 (1.3%)		4/158 (2.5%)		2/122 (1.6%)		3/149 (2%)		5/149 (3.4%)
Dermatitis diaper	16/159 (10.1%)		13/158 (8.2%)		1/159 (0.6%)		13/158 (8.2%)		7/122 (5.7%)		2/149 (1.3%)		4/149 (2.7%)
Eczema infantile	6/159 (3.8%)		8/158 (5.1%)		1/159 (0.6%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Asteatosis	5/159 (3.1%)		4/158 (2.5%)		0/159 (0%)		1/158 (0.6%)		1/122 (0.8%)		1/149 (0.7%)		1/149 (0.7%)
Dry skin	1/159 (0.6%)		6/158 (3.8%)		1/159 (0.6%)		2/158 (1.3%)		1/122 (0.8%)		1/149 (0.7%)		1/149 (0.7%)
Heat rash	3/159 (1.9%)		3/158 (1.9%)		0/159 (0%)		16/158 (10.1%)		2/122 (1.6%)		1/149 (0.7%)		1/149 (0.7%)
Dermatitis	1/159 (0.6%)		3/158 (1.9%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Dermatitis atopic	4/159 (2.5%)		0/158 (0%)		3/159 (1.9%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Dermatitis contact	3/159 (1.9%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		1/122 (0.8%)		0/149 (0%)		0/149 (0%)
Erythema	2/159 (1.3%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Rash generalised	0/159 (0%)		3/158 (1.9%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Urticaria	1/159 (0.6%)		1/158 (0.6%)		1/159 (0.6%)		3/158 (1.9%)		0/122 (0%)		2/149 (1.3%)		1/149 (0.7%)
Petechiae	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Pruritus	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		2/158 (1.3%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Rash	1/159 (0.6%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		2/122 (1.6%)		1/149 (0.7%)		2/149 (1.3%)
Seborrhoeic dermatitis	0/159 (0%)		1/158 (0.6%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Generalised erythema	0/159 (0%)		0/158 (0%)		0/159 (0%)		1/158 (0.6%)		0/122 (0%)		0/149 (0%)		0/149 (0%)
Dermal cyst	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		1/149 (0.7%)		0/149 (0%)
Eczema asteatotic	0/159 (0%)		0/158 (0%)		0/159 (0%)		0/158 (0%)		0/122 (0%)		0/149 (0%)		1/149 (0.7%)
Erythema (Any)	87/152 (57.2%)		22/152 (14.5%)		0/0 (NaN)		72/139 (51.8%)		56/108 (51.9%)		44/137 (32.1%)		0/0 (NaN)
Erythema (Any)	91/142 (64.1%)		59/150 (39.3%)		0/0 (NaN)		73/144 (50.7%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Any)	65/123 (52.8%)		44/144 (30.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		43/134 (32.1%)
Erythema (Mild)	80/152 (52.6%)		19/151 (12.6%)		0/0 (NaN)		63/139 (45.3%)		51/106 (48.1%)		39/137 (28.5%)		0/0 (NaN)
Erythema (Mild)	83/142 (58.5%)		50/150 (33.3%)		0/0 (NaN)		65/144 (45.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Mild)	57/123 (46.3%)		40/143 (28%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		36/133 (27.1%)
Erythema (Moderate)	22/148 (14.9%)		3/152 (2%)		0/0 (NaN)		14/136 (10.3%)		24/102 (23.5%)		10/134 (7.5%)		0/0 (NaN)
Erythema (Moderate)	43/134 (32.1%)		10/147 (6.8%)		0/0 (NaN)		19/140 (13.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Moderate)	24/120 (20%)		8/139 (5.8%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		13/131 (9.9%)
Erythema (Severe)	0/148 (0%)		0/151 (0%)		0/0 (NaN)		0/135 (0%)		0/98 (0%)		0/133 (0%)		0/0 (NaN)
Erythema (Severe)	0/133 (0%)		0/147 (0%)		0/0 (NaN)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Erythema (Severe)	0/118 (0%)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/130 (0%)
Induration (Any)	60/149 (40.3%)		12/153 (7.8%)		0/0 (NaN)		48/138 (34.8%)		46/108 (42.6%)		32/137 (23.4%)		0/0 (NaN)
Induration (Any)	71/137 (51.8%)		45/150 (30%)		0/0 (NaN)		47/144 (32.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Any)	55/124 (44.4%)		28/144 (19.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		37/134 (27.6%)
Induration (Mild)	57/149 (38.3%)		12/153 (7.8%)		0/0 (NaN)		45/138 (32.6%)		44/108 (40.7%)		27/137 (19.7%)		0/0 (NaN)
Induration (Mild)	68/137 (49.6%)		43/150 (28.7%)		0/0 (NaN)		43/143 (30.1%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Mild)	53/124 (42.7%)		28/144 (19.4%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		33/133 (24.8%)
Induration (Moderate)	15/148 (10.1%)		0/151 (0%)		0/0 (NaN)		11/135 (8.1%)		16/99 (16.2%)		9/133 (6.8%)		0/0 (NaN)
Induration (Moderate)	32/134 (23.9%)		10/148 (6.8%)		0/0 (NaN)		21/140 (15%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Moderate)	14/119 (11.8%)		3/139 (2.2%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		13/131 (9.9%)
Induration (Severe)	0/148 (0%)		0/151 (0%)		0/0 (NaN)		0/135 (0%)		0/98 (0%)		0/133 (0%)		0/0 (NaN)
Induration (Severe)	0/133 (0%)		0/147 (0%)		0/0 (NaN)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Induration (Severe)	0/118 (0%)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/130 (0%)
Tenderness (Any)	18/148 (12.2%)		1/151 (0.7%)		0/0 (NaN)		11/136 (8.1%)		11/99 (11.1%)		6/136 (4.4%)		0/0 (NaN)
Tenderness (Any)	10/133 (7.5%)		6/147 (4.1%)		0/0 (NaN)		7/139 (5%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Any)	6/119 (5%)		5/138 (3.6%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		9/132 (6.8%)
Tenderness (Significant)	0/148 (0%)		0/151 (0%)		0/0 (NaN)		0/135 (0%)		0/98 (0%)		0/133 (0%)		0/0 (NaN)
Tenderness (Significant)	0/133 (0%)		0/147 (0%)		0/0 (NaN)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Tenderness (Significant)	0/118 (0%)		0/138 (0%)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/130 (0%)

Limitations/Caveats

[Not Specified]

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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.