Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine
Official Title
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability and Immunogenicity of 2 and 3 Doses of 13vPnC in HIV-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2010
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
First Submitted Date
Aug 18, 2009
First Submission Date that Met QC Criteria
Aug 19, 2009
First Posted Date
Aug 20, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 17, 2014
Results First Submitted that Met QC Criteria
Nov 13, 2014
Results First Posted Date
Nov 17, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 13, 2014
Last Update Posted Date
Nov 17, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Pneumococcal Infections
Keywords
vaccine
13-valent pneumococcal conjugate vaccine
23-valent pneumococcal polysaccharide vaccine
human immunodeficiency virus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
303Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
3 doses of 13vPnC and 1 dose of 23vPS, each dose given approximately 1 month apart
13vPnC; 3 vaccinations given at approximately 1 month intervals at visits 1-3
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Other Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older
Viral load < 50,000 copies/mL and CD4+ T cell count >= 200/uL within 6 months before study vaccination
Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy
No previous vaccination with a pneumococcal vaccine
Subject or parent/legal guardian able to complete an electronic diary
Exclusion Criteria:
Acquired immune deficiency syndrome (AIDS) at time of enrollment
Current illicit substance and/or alcohol abuse
History of active chronic viral hepatitis
Previous anaphylactic reaction to a vaccine or vaccine-related component
Serious chronic disorders including metastatic malignancy and end-stage renal disease
Bhorat AE, Madhi SA, Laudat F, Sundaraiyer V, Gurtman A, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015 Jul 17;29(11):1345-54. doi: 10.1097/QAD.0000000000000689.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
23vPS; 1 vaccination given at visit 4 (approximately 1 month after visit 3)
1
Blood draw
Procedure
Blood draw; 5 blood draws approximately 1 month apart taken prior to vaccination at visits 1-4 and visit 5 (approximately 1 month after visit 4).
1
Blood draw
Procedure
1 or 2 blood draws for CD4+ T cell count and HIV viral load at least 6 weeks apart, if subject does not have 2 CD4+ T cell counts and HIV viral load counts within 6 months before visit 1.
1
Screening blood draw(s)
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.
Within 14 days after 13vPnC Dose 1
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Within 14 days after 13vPnC Dose 2
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Within 14 days after 13vPnC Dose 3
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.
Within 14 days after 13vPnC Dose 1
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.
Within 14 days after 13vPnC Dose 2
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.
Within 14 days after 13vPnC Dose 3
Bucharest
030303
Romania
Pfizer Investigational Site
Constanța
900709
Romania
Pfizer Investigational Site
Johannesburg
Gauteng
2013
South Africa
Pfizer Investigational Site
Pretoria
Gauteng
0083
South Africa
Pfizer Investigational Site
Pretoria
Gauteng
0122
South Africa
Pfizer Investigational Site
Soweto
Gauteng
1818
South Africa
Pfizer Investigational Site
Dundee
KwaZulu-Natal
3000
South Africa
Pfizer Investigational Site
Worcester
Western Cape
6850
South Africa
Pfizer Investigational Site
Bloemfontein
9301
South Africa
Pfizer Investigational Site
Paarl
7626
South Africa
FG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
FG000151 subjects
FG001152 subjects
Vaccinated 13vPnC Dose 1
FG000150 subjects
FG001151 subjects
Vaccinated 13vPnC Dose 2
FG000145 subjects
FG001145 subjects
Vaccinated 13vPnC Dose 3
FG000144 subjects
FG001142 subjects
Vaccinated 23vPS Dose
FG000143 subjects
FG001139 subjects
COMPLETED
FG000141 subjects
FG001138 subjects
NOT COMPLETED
FG00010 subjects
FG00114 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
Protocol Violation
FG0009 subjects
FG0014 subjects
Withdrawal by Subject
FG0001 subjects
FG0018 subjects
Other
FG0000 subjects
FG0011 subjects
Safety population included all enrolled participants who received at least 1 dose of investigational product.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
BG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000150
BG001151
BG002301
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00010.3± 3.04
BG00141.2± 8.45
BG00225.8± 16.72
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00076
BG00188
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.
Posted
Geometric Mean
95% Confidence Interval
fold rise
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000259
Title
Denominators
Categories
Serotype 1 (n = 248)
Title
Measurements
OG0001.03(0.99 to 1.07)
Serotype 3 (n = 238)
Title
Measurements
OG0001.05(1.00 to 1.10)
Serotype 4 (n = 257)
Secondary
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies all participants who were evaluable for this measure and "n" signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter (mcg/mL)
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Secondary
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
titers
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Secondary
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Other Pre-specified
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
titers
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Other Pre-specified
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
titers
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.
Evaluable immunogenicity population. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
fold rise
1 month after 13vPnC Dose 3, 1 month after 23vPS Dose
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.
Safety population. Here "N" (number of participants analyzed) signifies participants with known values for any local reaction and "n" signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Within 14 days after 13vPnC Dose 1
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Safety population. Here "N" (number of participants analyzed) signifies participants with known values for any local reaction and "n" signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Within 14 days after 13vPnC Dose 2
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Safety population. Here "N" (number of participants analyzed) signifies participants with known values for any local reaction and "n" signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Within 14 days after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG001
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.
Safety population. Here "N" (number of participants analyzed) signifies participants with known values for any systemic event and "n" signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Within 14 days after 13vPnC Dose 1
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.
Safety population. Here "N" (number of participants analyzed) signifies participants with known values for any systemic event and "n" signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Within 14 days after 13vPnC Dose 2
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Other Pre-specified
Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.
Safety population. Here "N" (number of participants analyzed) signifies participants with known values for any systemic event and "n" signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Within 14 days after 13vPnC Dose 3
ID
Title
Description
OG000
13vPnC, 23vPS (Pediatric Participants)
Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Time Frame
Informed consent through 6-month follow-up after 13vPnC Dose 3. Local reactions and systemic events assessed within 14 days after: 13vPnC Dose 1 (Day 1); 13vPnC Dose 2 (28-42 days after 13vPnC Dose 1); and 13vPnC Dose 3 (28-42 days after 13vPnC Dose 2)
Description
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Prior 13vPnC Dose 1
Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
1
301
16
301
EG001
13vPnC Dose 1
Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
1
301
216
301
EG002
13vPnC Dose 2
Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
4
290
171
290
EG003
13vPnC Dose 3
Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
1
286
137
286
EG004
23vPS Dose
Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
0
282
31
282
EG005
Follow-up
Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
1
282
2
282
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Convulsion
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG0030 affected286 at risk
EG0040 affected282 at risk
EG0050 affected282 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Pharyngitis bacterial
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Conjunctivitis
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG0030 affected186 at risk
EG0041 affected282 at risk
EG0050 affected182 at risk
Nausea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Salivary gland enlargement
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Gastroduodenitis
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Fatigue
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0013 affected301 at risk
EG0020 affected290 at risk
EG003
Pyrexia
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0012 affected301 at risk
EG0022 affected290 at risk
EG003
Influenza like illness
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Injection site pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Injection site reaction
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Injection site swelling
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Vaccination site swelling
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0015 affected301 at risk
EG0021 affected290 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0013 affected301 at risk
EG0020 affected290 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0006 affected301 at risk
EG0013 affected301 at risk
EG0024 affected290 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0012 affected301 at risk
EG0021 affected290 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0021 affected290 at risk
EG003
Otitis media
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0011 affected301 at risk
EG0022 affected290 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Tinea capitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Viraemia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Body tinea
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Pharyngitis bacterial
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Varicella
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0003 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Impetigo
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0013 affected301 at risk
EG0021 affected290 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0004 affected301 at risk
EG0014 affected301 at risk
EG0023 affected290 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0021 affected290 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Nasal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0011 affected301 at risk
EG0020 affected290 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected301 at risk
EG0010 affected301 at risk
EG0021 affected290 at risk
EG003
Redness (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG00121 affected180 at risk
EG00216 affected187 at risk
EG003
Redness (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG00120 affected179 at risk
EG00212 affected186 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected173 at risk
EG0024 affected180 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected172 at risk
EG0021 affected178 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG00138 affected191 at risk
EG00233 affected191 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG00124 affected184 at risk
EG00226 affected190 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG00116 affected181 at risk
EG00212 affected184 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG0011 affected172 at risk
EG0020 affected178 at risk
EG003
Pain at injection site (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG001156 affected238 at risk
EG002166 affected236 at risk
EG003
Pain at injection site (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG001127 affected228 at risk
EG002139 affected227 at risk
EG003
Pain at injection site (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG00144 affected188 at risk
EG00251 affected199 at risk
EG003
Pain at injection site (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
EG0000 affected0 at risk
EG0019 affected175 at risk
EG0028 affected179 at risk
EG003
Fever (≥38°C)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00135 affected189 at risk
EG00227 affected190 at risk
EG003
Fever (≥38°C but <38.5°C)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00115 affected179 at risk
EG00215 affected183 at risk
EG003
Fever (≥38.5°C but <39°C)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG0015 affected174 at risk
EG0027 affected183 at risk
EG003
Fever (≥39°C but ≤40°C)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG0016 affected174 at risk
EG00210 affected184 at risk
EG003
Fever (>40°C)
General disorders
Systemic events
Systematic Assessment
All reporting of fever >40 degrees C except 2 participants in 13vPnC Dose 1 and 1 participant in 13vPnC Dose 3 were confirmed as data entry errors.
EG0000 affected0 at risk
EG00114 affected181 at risk
EG0022 affected180 at risk
EG003
Fatigue (Any)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG001123 affected230 at risk
EG00286 affected211 at risk
EG003
Fatigue (Mild)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00193 affected218 at risk
EG00269 affected207 at risk
EG003
Fatigue (Moderate)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00153 affected195 at risk
EG00229 affected184 at risk
EG003
Fatigue (Severe)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00116 affected178 at risk
EG00212 affected183 at risk
EG003
Headache (Any)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG001111 affected220 at risk
EG00281 affected207 at risk
EG003
Headache (Mild)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00196 affected209 at risk
EG00259 affected199 at risk
EG003
Headache (Moderate)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00139 affected191 at risk
EG00239 affected190 at risk
EG003
Headache (Severe)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00114 affected176 at risk
EG0025 affected182 at risk
EG003
Vomiting (Any)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00123 affected180 at risk
EG00219 affected185 at risk
EG003
Vomiting (Mild)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00120 affected180 at risk
EG00214 affected183 at risk
EG003
Vomiting (Moderate)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected172 at risk
EG0024 affected179 at risk
EG003
Vomiting (Severe)
General disorders
Systemic events
Systematic Assessment
All reporting of severe vomiting were confirmed as data entry errors.
EG0000 affected0 at risk
EG0012 affected173 at risk
EG0023 affected179 at risk
EG003
Diarrhea (Any)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00160 affected199 at risk
EG00235 affected190 at risk
EG003
Diarrhea (Mild)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00149 affected196 at risk
EG00230 affected187 at risk
EG003
Diarrhea (Moderate)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00114 affected177 at risk
EG00210 affected180 at risk
EG003
Diarrhea (Severe)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG0012 affected173 at risk
EG0025 affected179 at risk
EG003
Muscle pain (Any)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG001126 affected226 at risk
EG00297 affected216 at risk
EG003
Muscle pain (Mild)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG001100 affected213 at risk
EG00275 affected208 at risk
EG003
Muscle pain (Moderate)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00136 affected187 at risk
EG00234 affected191 at risk
EG003
Muscle pain (Severe)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00110 affected177 at risk
EG0027 affected180 at risk
EG003
Joint pain (Any)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00179 affected205 at risk
EG00261 affected201 at risk
EG003
Joint pain (Mild)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00163 affected199 at risk
EG00243 affected193 at risk
EG003
Joint pain (Moderate)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG00128 affected184 at risk
EG00222 affected188 at risk
EG003
Joint pain (Severe)
General disorders
Systemic events
Systematic Assessment
EG0000 affected0 at risk
EG0018 affected175 at risk
EG0026 affected179 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Parotitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected301 at risk
EG0010 affected301 at risk
EG0020 affected290 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000128
OG001131
OG002259
Title
Denominators
Categories
Serotype 1: 13vPnC Dose 2 (n = 120, 128, 248)
Title
Measurements
OG0003.88(3.30 to 4.57)
OG0013.95(3.23 to 4.85)
OG0023.92(3.44 to 4.46)
Serotype 1: 13vPnC Dose 3 (n = 120, 128, 248)
Title
Measurements
OG0004.14(3.56 to 4.83)
OG0013.92(3.21 to 4.79)
OG0024.03(3.55 to 4.57)
Serotype 3: 13vPnC Dose 2 (n = 118, 120, 238)
Title
Measurements
OG0001.47(1.25 to 1.74)
OG0010.97(0.81 to 1.16)
OG0021.19(1.05 to 1.35)
Serotype 3: 13vPnC Dose 3 (n = 118, 120, 238)
Title
Measurements
OG0001.49(1.26 to 1.76)
OG0011.06(0.88 to 1.27)
OG0021.25(1.11 to 1.42)
Serotype 4: 13vPnC Dose 2 (n = 127, 130, 257)
Title
Measurements
OG0003.06(2.54 to 3.69)
OG0012.97(2.40 to 3.67)
OG0023.01(2.62 to 3.47)
Serotype 4: 13vPnC Dose 3 (n = 127, 130, 257)
Title
Measurements
OG0003.36(2.84 to 3.97)
OG0013.19(2.59 to 3.91)
OG0023.27(2.87 to 3.73)
Serotype 5: 13vPnC Dose 2 (n = 126, 131, 257)
Title
Measurements
OG0004.52(3.78 to 5.39)
OG0015.77(4.83 to 6.89)
OG0025.12(4.51 to 5.80)
Serotype 5: 13vPnC Dose 3 (n = 126, 131, 257)
Title
Measurements
OG0004.84(4.12 to 5.70)
OG0015.53(4.63 to 6.61)
OG0025.18(4.60 to 5.85)
Serotype 6A: 13vPnC Dose 2 (n = 119, 130, 249)
Title
Measurements
OG0007.66(6.46 to 9.08)
OG0017.03(5.71 to 8.67)
OG0027.33(6.40 to 8.39)
Serotype 6A: 13vPnC Dose 3 (n = 119, 130, 249)
Title
Measurements
OG0007.97(6.81 to 9.33)
OG0017.04(5.74 to 8.64)
OG0027.47(6.56 to 8.51)
Serotype 6B: 13vPnC Dose 2 (n = 127, 130, 257)
Title
Measurements
OG00011.43(9.45 to 13.84)
OG0017.93(6.51 to 9.65)
OG0029.50(8.28 to 10.91)
Serotype 6B: 13vPnC Dose 3 (n = 127, 130, 257)
Title
Measurements
OG00011.94(10.01 to 14.24)
OG0018.28(6.78 to 10.11)
OG0029.92(8.67 to 11.35)
Serotype 7F: 13vPnC Dose 2 (n = 128, 131, 259)
Title
Measurements
OG0004.25(3.67 to 4.92)
OG0015.78(4.81 to 6.95)
OG0024.96(4.41 to 5.59)
Serotype 7F: 13vPnC Dose 3 (n = 128, 131, 259)
Title
Measurements
OG0005.05(4.38 to 5.82)
OG0015.90(4.95 to 7.04)
OG0025.46(4.88 to 6.12)
Serotype 9V: 13vPnC Dose 2 (n = 128, 131, 259)
Title
Measurements
OG0004.81(4.18 to 5.54)
OG0015.14(4.27 to 6.19)
OG0024.98(4.43 to 5.59)
Serotype 9V: 13vPnC Dose 3 (n = 128, 131, 259)
Title
Measurements
OG0004.98(4.35 to 5.70)
OG0015.48(4.59 to 6.55)
OG0025.23(4.67 to 5.84)
Serotype 14: 13vPnC Dose 2 (n = 128, 131, 259)
Title
Measurements
OG00011.60(8.76 to 15.35)
OG00115.14(11.64 to 19.71)
OG00213.27(10.96 to 16.08)
Serotype 14: 13vPnC Dose 3 (n = 128, 131, 259)
Title
Measurements
OG00012.62(9.75 to 16.33)
OG00115.13(11.80 to 19.40)
OG00213.83(11.57 to 16.53)
Serotype 18C: 13vPnC Dose 2 (n = 128, 131, 259)
Title
Measurements
OG0003.79(3.12 to 4.60)
OG0015.33(4.34 to 6.54)
OG0024.50(3.91 to 5.19)
Serotype 18C: 13vPnC Dose 3 (n = 128, 131, 259)
Title
Measurements
OG0003.83(3.19 to 4.60)
OG0015.18(4.27 to 6.28)
OG0024.46(3.90 to 5.10)
Serotype 19A: 13vPnC Dose 2 (n = 128, 131, 259)
Title
Measurements
OG00014.38(12.20 to 16.96)
OG00113.19(11.06 to 15.75)
OG00213.77(12.21 to 15.53)
Serotype 19A: 13vPnC Dose 3 (n = 128, 131, 259)
Title
Measurements
OG00014.19(12.17 to 16.54)
OG00113.18(11.11 to 15.62)
OG00213.67(12.20 to 15.32)
Serotype 19F: 13vPnC Dose 2 (n = 124, 128, 252)
Title
Measurements
OG0005.78(4.63 to 7.21)
OG0015.34(4.17 to 6.84)
OG0025.55(4.71 to 6.55)
Serotype 19F: 13vPnC Dose 3 (n = 124, 128, 252)
Title
Measurements
OG0006.09(4.98 to 7.44)
OG0015.67(4.47 to 7.18)
OG0025.87(5.03 to 6.85)
Serotype 23F: 13vPnC Dose 2 (n = 127, 131, 258)
Title
Measurements
OG0006.45(5.30 to 7.85)
OG0016.10(4.86 to 7.66)
OG0026.27(5.40 to 7.28)
Serotype 23F: 13vPnC Dose 3 (n = 127, 131, 258)
Title
Measurements
OG0006.64(5.55 to 7.94)
OG0017.06(5.65 to 8.82)
OG0026.85(5.94 to 7.90)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000127
OG001129
OG002256
Title
Denominators
Categories
Serotype 1: 13vPnC Dose 2 (n = 126, 127, 253)
Title
Measurements
OG00051(37.2 to 70.0)
OG00154(38.7 to 74.2)
OG00252(41.8 to 65.5)
Serotype 1: 13vPnC Dose 3 (n = 126, 127, 253)
Title
Measurements
OG00069(51.6 to 91.4)
OG00169(51.3 to 92.0)
OG00269(56.1 to 84.1)
Serotype 3: 13vPnC Dose 2 (n = 127, 129, 256)
Title
Measurements
OG00081(64.1 to 102.0)
OG00148(37.9 to 61.5)
OG00262(52.6 to 73.9)
Serotype 3: 13vPnC Dose 3 (n = 127, 129, 256)
Title
Measurements
OG000114(94.5 to 137.8)
OG00179(62.1 to 99.9)
OG00295(81.3 to 110.3)
Serotype 4: 13vPnC Dose 2 (n = 117, 126, 243)
Title
Measurements
OG0002509(1922.3 to 3274.2)
OG0011620(1211.2 to 2167.4)
OG0022000(1639.8 to 2439.1)
Serotype 4: 13vPnC Dose 3 (n = 117, 126, 243)
Title
Measurements
OG0003246(2697.1 to 3906.3)
OG0011944(1465.3 to 2579.7)
OG0022488(2092.1 to 2959.8)
Serotype 5: 13vPnC Dose 2 (n = 122, 124, 246)
Title
Measurements
OG000159(109.2 to 232.2)
OG001104(69.1 to 156.9)
OG002129(97.3 to 169.7)
Serotype 5: 13vPnC Dose 3 (n = 122, 124, 246)
Title
Measurements
OG000267(191.3 to 371.5)
OG001142(97.5 to 206.7)
OG002194(150.8 to 249.7)
Serotype 6A: 13vPnC Dose 2 (n = 125, 124, 249)
Title
Measurements
OG0005560(4378.4 to 7060.9)
OG0012425(1790.7 to 3284.5)
OG0023678(3016.2 to 4485.6)
Serotype 6A: 13vPnC Dose 3 (n = 125, 124, 249)
Title
Measurements
OG0007758(6314.2 to 9531.2)
OG0013239(2488.5 to 4215.9)
OG0025022(4216.8 to 5979.9)
Serotype 6B: 13vPnC Dose 2 (n = 121, 128, 249)
Title
Measurements
OG0005449(4365.1 to 6801.1)
OG0012724(2004.8 to 3701.0)
OG0023815(3140.9 to 4634.1)
Serotype 6B: 13vPnC Dose 3 (n = 121, 128, 249)
Title
Measurements
OG0007151(5828.2 to 8773.9)
OG0013723(2771.1 to 5002.5)
OG0025113(4250.1 to 6150.5)
Serotype 7F: 13vPnC Dose 2 (n = 125, 127, 252)
Title
Measurements
OG0003494(2772.8 to 4403.3)
OG0012255(1739.6 to 2923.6)
OG0022802(2352.6 to 3338.0)
Serotype 7F: 13vPnC Dose 3 (n = 125, 127, 252)
Title
Measurements
OG0004638(3889.7 to 5529.4)
OG0012702(2130.3 to 3428.2)
OG0023533(3037.4 to 4108.5)
Serotype 9V: 13vPnC Dose 2 (n = 118, 127, 245)
Title
Measurements
OG0003339(2461.4 to 4530.3)
OG0011432(998.6 to 2054.9)
OG0022153(1690.3 to 2743.3)
Serotype 9V: 13vPnC Dose 3 (n = 118, 127, 245)
Title
Measurements
OG0004714(3731.5 to 5955.4)
OG0012004(1416.5 to 2836.1)
OG0023026(2434.3 to 3761.4)
Serotype 14: 13vPnC Dose 2 (n = 117, 127, 244)
Title
Measurements
OG0003704(2906.5 to 4719.5)
OG0011342(1010.1 to 1782.1)
OG0022183(1792.2 to 2659.6)
Serotype 14: 13vPnC Dose 3 (n = 117, 127, 244)
Title
Measurements
OG0003963(3195.8 to 4914.2)
OG0011480(1150.3 to 1903.9)
OG0022373(1988.4 to 2832.8)
Serotype 18C: 13vPnC Dose 2 (n = 117, 121, 238)
Title
Measurements
OG0004635(3609.7 to 5951.8)
OG0011349(947.0 to 1921.5)
OG0022475(1965.7 to 3115.4)
Serotype 18C: 13vPnC Dose 3 (n = 117, 121, 238)
Title
Measurements
OG0005579(4423.7 to 7036.9)
OG0011787(1272.8 to 2508.5)
OG0023127(2515.2 to 3888.6)
Serotype 19A: 13vPnC Dose 2 (n = 125, 127, 252)
Title
Measurements
OG000684(519.2 to 902.1)
OG001458(332.5 to 631.2)
OG002559(452.3 to 690.9)
Serotype 19A: 13vPnC Dose 3 (n = 125, 127, 252)
Title
Measurements
OG0001002(814.5 to 1232.3)
OG001613(465.6 to 806.4)
OG002782(657.2 to 930.5)
Serotype 19F: 13vPnC Dose 2 (n = 122, 118, 240)
Title
Measurements
OG000717(495.6 to 1036.7)
OG001315(196.7 to 506.0)
OG002479(354.4 to 646.9)
Serotype 19F: 13vPnC Dose 3 (n = 122, 118, 240)
Title
Measurements
OG0001152(864.2 to 1535.0)
OG001597(397.9 to 897.1)
OG002834(650.1 to 1070.2)
Serotype 23F: 13vPnC Dose 2 (n = 120, 126, 246)
Title
Measurements
OG0001477(1086.2 to 2008.2)
OG001409(271.9 to 614.0)
OG002765(585.2 to 999.4)
Serotype 23F: 13vPnC Dose 3 (n = 120, 126, 246)
Title
Measurements
OG0002327(1844.2 to 2935.9)
OG001671(449.8 to 1000.3)
OG0021231(963.0 to 1572.5)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000127
OG001129
OG002256
Title
Denominators
Categories
Serotype 1 (n = 126, 127, 253)
Title
Measurements
OG0001.3(1.13 to 1.61)
OG0011.3(1.09 to 1.51)
OG0021.3(1.16 to 1.48)
Serotype 3 (n = 127, 129, 256)
Title
Measurements
OG0001.4(1.25 to 1.59)
OG0011.6(1.45 to 1.83)
OG0021.5(1.40 to 1.65)
Serotype 4 (n = 117, 126, 243)
Title
Measurements
OG0001.3(1.10 to 1.52)
OG0011.2(1.07 to 1.34)
OG0021.2(1.13 to 1.37)
Serotype 5 (n = 122, 124, 246)
Title
Measurements
OG0001.7(1.36 to 2.06)
OG0011.4(1.17 to 1.59)
OG0021.5(1.33 to 1.72)
Serotype 6A (n = 125, 124, 249)
Title
Measurements
OG0001.4(1.22 to 1.60)
OG0011.3(1.15 to 1.55)
OG0021.4(1.23 to 1.51)
Serotype 6B (n = 121, 128, 249)
Title
Measurements
OG0001.3(1.18 to 1.46)
OG0011.4(1.20 to 1.56)
OG0021.3(1.23 to 1.46)
Serotype 7F (n = 125, 127, 252)
Title
Measurements
OG0001.3(1.15 to 1.53)
OG0011.2(1.03 to 1.40)
OG0021.3(1.14 to 1.40)
Serotype 9V (n = 118, 127, 245)
Title
Measurements
OG0001.4(1.16 to 1.72)
OG0011.4(1.18 to 1.65)
OG0021.4(1.24 to 1.60)
Serotype 14 (n = 117, 127, 244)
Title
Measurements
OG0001.1(0.95 to 1.20)
OG0011.1(0.98 to 1.24)
OG0021.1(1.00 to 1.18)
Serotype 18C (n = 117, 121, 238)
Title
Measurements
OG0001.2(1.10 to 1.32)
OG0011.3(1.08 to 1.63)
OG0021.3(1.13 to 1.42)
Serotype 19A (n = 125, 127, 252)
Title
Measurements
OG0001.5(1.27 to 1.68)
OG0011.3(1.18 to 1.52)
OG0021.4(1.27 to 1.54)
Serotype 19F (n = 122, 118, 240)
Title
Measurements
OG0001.6(1.31 to 1.97)
OG0011.9(1.45 to 2.48)
OG0021.7(1.48 to 2.06)
Serotype 23F (n = 120, 126, 246)
Title
Measurements
OG0001.6(1.31 to 1.90)
OG0011.6(1.34 to 2.02)
OG0021.6(1.40 to 1.85)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000128
OG001131
Title
Denominators
Categories
Serotype 1 (n = 120, 128)
Title
Measurements
OG0001.07(1.01 to 1.13)
OG0010.99(0.93 to 1.06)
Serotype 3 (n = 118, 120)
Title
Measurements
OG0001.01(0.95 to 1.08)
OG0011.09(1.02 to 1.16)
Serotype 4 (n = 127, 130)
Title
Measurements
OG0001.10(1.02 to 1.18)
OG0011.07(1.00 to 1.16)
Serotype 5 (n = 126, 131)
Title
Measurements
OG0001.07(1.01 to 1.14)
OG0010.96(0.91 to 1.01)
Serotype 6A (n = 119, 130)
Title
Measurements
OG0001.04(0.96 to 1.12)
OG0011.00(0.95 to 1.06)
Serotype 6B (n = 127, 130)
Title
Measurements
OG0001.04(0.99 to 1.10)
OG0011.04(0.99 to 1.11)
Serotype 7F (n = 128, 131)
Title
Measurements
OG0001.19(1.12 to 1.27)
OG0011.02(0.95 to 1.10)
Serotype 9V (n = 128, 131)
Title
Measurements
OG0001.03(0.98 to 1.09)
OG0011.07(1.02 to 1.12)
Serotype 14 (n = 128, 131)
Title
Measurements
OG0001.09(1.02 to 1.16)
OG0011.00(0.95 to 1.05)
Serotype 18C (n = 128, 131)
Title
Measurements
OG0001.01(0.96 to 1.07)
OG0010.97(0.93 to 1.01)
Serotype 19A (n = 128, 131)
Title
Measurements
OG0000.99(0.93 to 1.04)
OG0011.00(0.96 to 1.04)
Serotype 19F (n = 124, 128)
Title
Measurements
OG0001.05(0.98 to 1.13)
OG0011.06(0.99 to 1.14)
Serotype 23F (n = 127, 131)
Title
Measurements
OG0001.03(0.96 to 1.11)
OG0011.16(1.07 to 1.26)
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000133
OG001137
OG002270
Title
Denominators
Categories
Serotype 1: Before 13vPnC Dose 1 (n=78,122,200)
Title
Measurements
OG0001.03(0.72 to 1.48)
OG0010.82(0.63 to 1.06)
OG0020.90(0.73 to 1.10)
Serotype 1: After 13vPnC Dose 1 (n=78,122,200)
Title
Measurements
OG0003.78(2.97 to 4.80)
OG0014.00(3.19 to 5.01)
OG0023.91(3.32 to 4.61)
Serotype 3: Before 13vPnC Dose 1 (n=99,127,226)
Title
Measurements
OG0000.83(0.62 to 1.11)
OG0010.47(0.37 to 0.58)
OG0020.60(0.50 to 0.72)
Serotype 3: After 13vPnC Dose 1 (n=99,127,226)
Title
Measurements
OG0001.25(0.99 to 1.58)
OG0010.75(0.62 to 0.92)
OG0020.94(0.81 to 1.09)
Serotype 4: Before 13vPnC Dose 1 (n=95,127,222)
Title
Measurements
OG0000.19(0.14 to 0.25)
OG0010.35(0.28 to 0.45)
OG0020.27(0.22 to 0.33)
Serotype 4: After 13vPnC Dose 1 (n=95,127,222)
Title
Measurements
OG0002.62(1.97 to 3.50)
OG0012.91(2.26 to 3.75)
OG0022.79(2.31 to 3.36)
Serotype 5: Before 13vPnC Dose 1 (n=122,137,259)
Title
Measurements
OG0004.18(3.42 to 5.12)
OG0013.38(2.84 to 4.02)
OG0023.74(3.28 to 4.27)
Serotype 5: After 13vPnC Dose 1 (n=122,137,259)
Title
Measurements
OG0004.81(3.98 to 5.80)
OG0015.53(4.63 to 6.61)
OG0025.18(4.55 to 5.89)
Serotype 6A: Before 13vPnC Dose 1 (n=99,136,235)
Title
Measurements
OG0006.22(5.19 to 7.45)
OG0012.67(2.24 to 3.18)
OG0023.81(3.32 to 4.37)
Serotype 6A: After 13vPnC Dose 1 (n=99,136,235)
Title
Measurements
OG0007.31(6.07 to 8.79)
OG0016.77(5.38 to 8.51)
OG0026.99(6.00 to 8.15)
Serotype 6B: Before 13vPnC Dose 1 (n=131,134,265)
Title
Measurements
OG0005.52(4.59 to 6.64)
OG0013.23(2.69 to 3.88)
OG0024.21(3.69 to 4.81)
Serotype 6B: After 13vPnC Dose 1 (n=131,134,265)
Title
Measurements
OG00010.26(8.37 to 12.58)
OG0017.29(5.81 to 9.15)
OG0028.63(7.41 to 10.06)
Serotype 7F: Before 13vPnC Dose 1 (n=111,134,245)
Title
Measurements
OG0000.85(0.63 to 1.14)
OG0011.14(0.94 to 1.37)
OG0021.00(0.84 to 1.18)
Serotype 7F: After 13vPnC Dose 1 (n=111,134,245)
Title
Measurements
OG0004.34(3.68 to 5.11)
OG0015.57(4.57 to 6.78)
OG0024.97(4.36 to 5.67)
Serotype 9V: Before 13vPnC Dose 1 (n=129,137,266)
Title
Measurements
OG0002.10(1.74 to 2.54)
OG0011.56(1.30 to 1.86)
OG0021.80(1.58 to 2.05)
Serotype 9V: After 13vPnC Dose 1 (n=129,137,266)
Title
Measurements
OG0004.77(4.08 to 5.57)
OG0015.16(4.24 to 6.27)
OG0024.97(4.38 to 5.63)
Serotype 14: Before 13vPnC Dose 1 (n=113,136,249)
Title
Measurements
OG0000.76(0.57 to 1.03)
OG0012.45(1.94 to 3.09)
OG0021.44(1.18 to 1.76)
Serotype 14: After 13vPnC Dose 1 (n=113,136,249)
Title
Measurements
OG00012.04(8.48 to 17.10)
OG00116.46(12.38 to 21.90)
OG00214.28(11.44 to 17.84)
Serotype 18C: Before 13vPnC Dose 1 (n=127,134,261)
Title
Measurements
OG0000.66(0.52 to 0.85)
OG0010.85(0.69 to 1.04)
OG0020.75(0.64 to 0.88)
Serotype 18C: After 13vPnC Dose 1 (n=127,134,261)
Title
Measurements
OG0003.92(3.14 to 4.91)
OG0015.55(4.51 to 6.84)
OG0024.69(4.02 to 5.46)
Serotype 19A: Before 13vPnC Dose 1 (n=133,137,270)
Title
Measurements
OG0007.51(6.34 to 8.90)
OG0014.78(4.04 to 5.66)
OG0025.97(5.29 to 6.74)
Serotype 19A: After 13vPnC Dose 1 (n=133,137,270)
Title
Measurements
OG00013.28(11.11 to 15.87)
OG00113.03(10.75 to 15.80)
OG00213.15(11.54 to 14.99)
Serotype 19F: Before 13vPnC Dose 1 (n=93,126,219)
Title
Measurements
OG0001.36(1.06 to 1.75)
OG0011.36(1.07 to 1.73)
OG0021.36(1.14 to 1.62)
Serotype 19F: After 13vPnC Dose 1 (n=93,126,219)
Title
Measurements
OG0004.62(3.55 to 6.02)
OG0014.98(3.74 to 6.62)
OG0024.82(3.96 to 5.88)
Serotype 23F: Before 13vPnC Dose 1 (n=126,137,263)
Title
Measurements
OG0002.29(1.83 to 2.86)
OG0011.61(1.31 to 1.96)
OG0021.90(1.64 to 2.21)
Serotype 23F: After 13vPnC Dose 1 (n=126,137,263)
Title
Measurements
OG0005.65(4.66 to 6.86)
OG0015.30(4.16 to 6.75)
OG0025.47(4.68 to 6.39)
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000133
OG001137
OG002270
Title
Denominators
Categories
Serotype 1 (n = 78, 122, 200)
Title
Measurements
OG0003.67(2.70 to 4.99)
OG0014.88(3.87 to 6.15)
OG0024.37(3.63 to 5.25)
Serotype 3 (n = 99, 127, 226)
Title
Measurements
OG0001.51(1.27 to 1.79)
OG0011.62(1.43 to 1.83)
OG0021.57(1.42 to 1.74)
Serotype 4 (n = 95, 127, 222)
Title
Measurements
OG00014.02(10.55 to 18.62)
OG0018.29(6.55 to 10.49)
OG00210.38(8.64 to 12.47)
Serotype 5 (n = 122, 137, 259)
Title
Measurements
OG0001.15(1.06 to 1.25)
OG0011.64(1.44 to 1.85)
OG0021.38(1.28 to 1.50)
Serotype 6A (n = 99, 136, 235)
Title
Measurements
OG0001.18(1.02 to 1.35)
OG0012.54(2.09 to 3.07)
OG0021.83(1.60 to 2.10)
Serotype 6B (n = 131, 134, 265)
Title
Measurements
OG0001.86(1.55 to 2.22)
OG0012.26(1.87 to 2.72)
OG0022.05(1.80 to 2.33)
Serotype 7F (n = 111, 134, 245)
Title
Measurements
OG0005.11(3.92 to 6.65)
OG0014.90(3.99 to 6.03)
OG0024.99(4.24 to 5.88)
Serotype 9V (n = 129, 137, 266)
Title
Measurements
OG0002.27(1.97 to 2.61)
OG0013.32(2.76 to 3.99)
OG0022.76(2.45 to 3.10)
Serotype 14 (n = 113, 136, 249)
Title
Measurements
OG00015.79(11.84 to 21.05)
OG0016.73(5.17 to 8.76)
OG0029.91(8.11 to 12.11)
Serotype 18C (n = 127, 134, 261)
Title
Measurements
OG0005.92(4.64 to 7.55)
OG0016.55(5.23 to 8.20)
OG0026.23(5.29 to 7.35)
Serotype 19A (n = 133, 137, 270)
Title
Measurements
OG0001.77(1.55 to 2.02)
OG0012.73(2.31 to 3.21)
OG0022.20(1.98 to 2.45)
Serotype 19F (n = 93, 126, 219)
Title
Measurements
OG0003.39(2.71 to 4.25)
OG0013.66(2.96 to 4.52)
OG0023.54(3.04 to 4.13)
Serotype 23F (n = 126, 137, 263)
Title
Measurements
OG0002.47(2.02 to 3.02)
OG0013.30(2.71 to 4.03)
OG0022.87(2.49 to 3.31)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000129
OG001128
OG002257
Title
Denominators
Categories
Serotype 1: Before 13vPnC Dose 1 (n=129,127,256)
Title
Measurements
OG0005(4.3 to 5.8)
OG0015(4.3 to 5.2)
OG0025(4.4 to 5.3)
Serotype 1: After 13vPnC Dose 1 (n=129,127,256)
Title
Measurements
OG00049(35.3 to 68.1)
OG00157(41.6 to 79.3)
OG00253(42.2 to 66.7)
Serotype 3: Before 13vPnC Dose 1 (n=126,128,254)
Title
Measurements
OG0008(6.6 to 10.8)
OG0015(4.5 to 5.8)
OG0027(5.7 to 7.5)
Serotype 3: After 13vPnC Dose 1 (n=126,128,254)
Title
Measurements
OG00041(31.7 to 52.6)
OG00121(16.3 to 27.1)
OG00229(24.3 to 35.1)
Serotype 4: Before 13vPnC Dose 1 (n=108,119,227)
Title
Measurements
OG00025(15.2 to 41.7)
OG00127(17.0 to 42.1)
OG00226(18.6 to 36.3)
Serotype 4: After 13vPnC Dose 1 (n=108,119,227)
Title
Measurements
OG0002247(1611.9 to 3131.4)
OG0011372(958.8 to 1963.7)
OG0021735(1356.9 to 2218.3)
Serotype 5: Before 13vPnC Dose 1 (n=125,122,247)
Title
Measurements
OG0005(4.5 to 6.7)
OG0016(4.8 to 6.8)
OG0026(4.9 to 6.4)
Serotype 5: After 13vPnC Dose 1 (n=125,122,247)
Title
Measurements
OG00079(52.5 to 118.0)
OG001123(81.8 to 186.3)
OG00298(73.7 to 131.1)
Serotype 6A: Before 13vPnC Dose 1 (n=99,98,197)
Title
Measurements
OG000157(84.4 to 292.5)
OG00161(35.1 to 106.8)
OG00298(64.6 to 149.4)
Serotype 6A: After 13vPnC Dose 1 (n=99,98,197)
Title
Measurements
OG0003480(2460.1 to 4921.8)
OG0011543(984.4 to 2418.5)
OG0022322(1743.1 to 3092.9)
Serotype 6B: Before 13vPnC Dose 1 (n=101,120,221)
Title
Measurements
OG000279(155.5 to 501.1)
OG001231(143.4 to 372.5)
OG002252(174.1 to 364.6)
Serotype 6B: After 13vPnC Dose 1 (n=101,120,221)
Title
Measurements
OG0003852(2888.3 to 5137.8)
OG0012099(1455.6 to 3028.2)
OG0022771(2179.2 to 3522.5)
Serotype 7F: Before 13vPnC Dose 1 (n=110,113,223)
Title
Measurements
OG000416(253.5 to 682.9)
OG00138(22.9 to 64.6)
OG002124(84.3 to 183.8)
Serotype 7F: After 13vPnC Dose 1 (n=110,113,223)
Title
Measurements
OG0003775(3019.4 to 4720.1)
OG0012005(1443.9 to 2783.1)
OG0022739(2237.5 to 3353.5)
Serotype 9V: Before 13vPnC Dose 1 (n=109,117,226)
Title
Measurements
OG000152(87.2 to 266.2)
OG00169(40.7 to 117.2)
OG002101(68.8 to 148.6)
Serotype 9V: After 13vPnC Dose 1 (n=109,117,226)
Title
Measurements
OG0002533(1822.7 to 3520.3)
OG0011231(836.1 to 1812.2)
OG0021743(1347.0 to 2256.4)
Serotype 14: Before 13vPnC Dose 1 (n=107,126,233)
Title
Measurements
OG000328(201.4 to 535.5)
OG001123(79.6 to 191.4)
OG002193(139.0 to 269.2)
Serotype 14: After 13vPnC Dose 1 (n=107,126,233)
Title
Measurements
OG0003571(2772.2 to 4600.1)
OG0011277(944.9 to 1725.8)
OG0022048(1660.8 to 2524.9)
Serotype 18C: Before 13vPnC Dose 1 (n=95,120,215)
Title
Measurements
OG00042(21.9 to 79.0)
OG00125(15.5 to 39.6)
OG00231(21.2 to 45.8)
Serotype 18C: After 13vPnC Dose 1 (n=95,120,215)
Title
Measurements
OG0002821(1891.1 to 4208.9)
OG0011031(671.3 to 1584.6)
OG0021609(1188.2 to 2178.5)
Serotype 19A: Before 13vPnC Dose 1 (n=129,128,257)
Title
Measurements
OG00028(19.1 to 40.8)
OG00123(16.7 to 32.7)
OG00226(19.9 to 32.9)
Serotype 19A: After 13vPnC Dose 1 (n=129,128,257)
Title
Measurements
OG000506(381.9 to 671.7)
OG001390(275.2 to 552.8)
OG002445(355.7 to 555.9)
Serotype 19F: Before 13vPnC Dose 1 (n=123,123,246)
Title
Measurements
OG00011(7.6 to 15.5)
OG00114(9.5 to 20.1)
OG00212(9.5 to 15.8)
Serotype 19F: After 13vPnC Dose 1 (n=123,123,246)
Title
Measurements
OG000425(285.3 to 632.5)
OG001214(130.4 to 352.3)
OG002302(219.3 to 415.2)
Serotype 23F: Before 13vPnC Dose 1 (n=118,125,243)
Title
Measurements
OG00014(9.3 to 22.0)
OG0017(5.3 to 9.0)
OG00210(7.6 to 12.7)
Serotype 23F: After 13vPnC Dose 1 (n=118,125,243)
Title
Measurements
OG000587(379.3 to 907.7)
OG001140(86.6 to 227.6)
OG002281(200.8 to 393.7)
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000129
OG001128
OG002257
Title
Denominators
Categories
Serotype 1 (n = 129, 127, 256)
Title
Measurements
OG0009.8(6.97 to 13.81)
OG00112.2(8.84 to 16.84)
OG00210.9(8.65 to 13.81)
Serotype 3 (n = 126, 128, 254)
Title
Measurements
OG0004.8(3.72 to 6.30)
OG0014.1(3.22 to 5.30)
OG0024.5(3.73 to 5.35)
Serotype 4 (n = 108, 119, 227)
Title
Measurements
OG00089.4(51.43 to 155.31)
OG00151.3(31.16 to 84.59)
OG00266.8(46.17 to 96.75)
Serotype 5 (n = 125, 122, 247)
Title
Measurements
OG00014.4(9.56 to 21.67)
OG00121.7(14.55 to 32.32)
OG00217.6(13.25 to 23.44)
Serotype 6A (n = 99, 98, 197)
Title
Measurements
OG00022.2(12.61 to 38.90)
OG00125.2(14.51 to 43.83)
OG00223.6(15.98 to 34.94)
Serotype 6B (n = 101, 120, 221)
Title
Measurements
OG00013.8(8.12 to 23.45)
OG0019.1(5.91 to 13.95)
OG00211.0(7.87 to 15.37)
Serotype 7F (n = 110, 113, 223)
Title
Measurements
OG0009.1(5.79 to 14.23)
OG00152.2(31.42 to 86.57)
OG00222.0(15.42 to 31.42)
Serotype 9V (n = 109, 117, 226)
Title
Measurements
OG00016.6(9.71 to 28.47)
OG00117.8(10.53 to 30.18)
OG00217.2(11.87 to 25.04)
Serotype 14 (n = 107, 126, 233)
Title
Measurements
OG00010.9(6.79 to 17.41)
OG00110.3(6.82 to 15.70)
OG00210.6(7.76 to 14.44)
Serotype 18C (n = 95, 120, 215)
Title
Measurements
OG00067.9(35.25 to 130.73)
OG00141.6(24.59 to 70.26)
OG00251.6(34.27 to 77.78)
Serotype 19A (n = 129, 128, 257)
Title
Measurements
OG00018.1(12.52 to 26.25)
OG00116.7(11.78 to 23.61)
OG00217.4(13.51 to 22.38)
Serotype 19F (n = 123, 123, 246)
Title
Measurements
OG00039.0(24.56 to 62.05)
OG00115.5(9.77 to 24.65)
OG00224.6(17.69 to 34.25)
Serotype 23F (n = 118, 125, 243)
Title
Measurements
OG00041.1(24.94 to 67.81)
OG00120.2(12.78 to 32.05)
OG00228.6(20.34 to 40.10)
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000133
OG001130
OG002263
Title
Denominators
Categories
Serotype 1: After 13vPnC Dose 3 (n=128,127,255)
Title
Measurements
OG0004.08(3.53 to 4.73)
OG0013.94(3.22 to 4.82)
OG0024.01(3.54 to 4.54)
Serotype 1: After 23vPS Dose (n=128,127,255)
Title
Measurements
OG0004.42(3.80 to 5.14)
OG0014.02(3.32 to 4.85)
OG0024.21(3.74 to 4.75)
Serotype 3: After 13vPnC Dose 3 (n=124,118,242)
Title
Measurements
OG0001.49(1.27 to 1.75)
OG0011.04(0.87 to 1.26)
OG0021.25(1.11 to 1.42)
Serotype 3: After 23vPS Dose (n=124,118,242)
Title
Measurements
OG0001.65(1.42 to 1.92)
OG0010.98(0.82 to 1.17)
OG0021.28(1.14 to 1.44)
Serotype 4: After 13vPnC Dose 3 (n=133,128,261)
Title
Measurements
OG0003.29(2.79 to 3.87)
OG0013.19(2.59 to 3.93)
OG0023.24(2.84 to 3.70)
Serotype 4: After 23vPS Dose (n=133,128,261)
Title
Measurements
OG0003.28(2.77 to 3.88)
OG0013.01(2.44 to 3.72)
OG0023.15(2.75 to 3.59)
Serotype 5: After 13vPnC Dose 3 (n=132,130,262)
Title
Measurements
OG0004.73(4.02 to 5.57)
OG0015.54(4.64 to 6.63)
OG0025.12(4.54 to 5.78)
Serotype 5: After 23vPS Dose (n=132,130,262)
Title
Measurements
OG0005.08(4.33 to 5.95)
OG0016.20(5.23 to 7.35)
OG0025.61(4.99 to 6.30)
Serotype 6A: After 13vPnC Dose 3 (n=122,129,251)
Title
Measurements
OG0008.20(6.99 to 9.61)
OG0017.07(5.75 to 8.69)
OG0027.60(6.67 to 8.66)
Serotype 6A: After 23vPS Dose (n=122,129,251)
Title
Measurements
OG0007.98(6.85 to 9.31)
OG0016.71(5.51 to 8.17)
OG0027.30(6.44 to 8.27)
Serotype 6B: After 13vPnC Dose 3 (n=133,129,262)
Title
Measurements
OG00012.25(10.31 to 14.55)
OG0018.29(6.78 to 10.13)
OG00210.10(8.84 to 11.55)
Serotype 6B: After 23vPS Dose (n=133,129,262)
Title
Measurements
OG00011.10(9.39 to 13.13)
OG0018.25(6.80 to 10.01)
OG0029.59(8.44 to 10.90)
Serotype 7F: After 13vPnC Dose 3 (n=133,130,263)
Title
Measurements
OG0005.05(4.39 to 5.81)
OG0015.88(4.93 to 7.02)
OG0025.44(4.87 to 6.09)
Serotype 7F: After 23vPS Dose (n=133,130,263)
Title
Measurements
OG0005.15(4.50 to 5.90)
OG0015.93(5.02 to 7.00)
OG0025.52(4.96 to 6.14)
Serotype 9V: After 13vPnC Dose 3 (n=133,130,263)
Title
Measurements
OG0005.02(4.40 to 5.72)
OG0015.49(4.59 to 6.57)
OG0025.25(4.70 to 5.86)
Serotype 9V: After 23vPS Dose (n=133,130,263)
Title
Measurements
OG0005.27(4.62 to 6.00)
OG0015.83(4.88 to 6.96)
OG0025.54(4.96 to 6.18)
Serotype 14: After 13vPnC Dose 3 (n=133,130,263)
Title
Measurements
OG00013.18(10.19 to 17.05)
OG00115.35(11.97 to 19.69)
OG00214.21(11.89 to 16.98)
Serotype 14: After 23vPS Dose (n=133,130,263)
Title
Measurements
OG00012.98(10.10 to 16.67)
OG00116.24(12.82 to 20.57)
OG00214.50(12.21 to 17.21)
Serotype 18C: After 13vPnC Dose 3 (n=132,130,262)
Title
Measurements
OG0003.84(3.21 to 4.59)
OG0015.17(4.25 to 6.28)
OG0024.45(3.90 to 5.08)
Serotype 18C: After 23vPS Dose (n=132,130,262)
Title
Measurements
OG0003.54(2.98 to 4.20)
OG0014.80(3.98 to 5.79)
OG0024.12(3.62 to 4.68)
Serotype 19A: After 13vPnC Dose 3 (n=133,130,263)
Title
Measurements
OG00014.16(12.21 to 16.41)
OG00113.21(11.13 to 15.68)
OG00213.68(12.22 to 15.31)
Serotype 19A: After 23vPS Dose (n=133,130,263)
Title
Measurements
OG00013.16(11.31 to 15.33)
OG00113.28(11.24 to 15.69)
OG00213.22(11.82 to 14.79)
Serotype 19F: After 13vPnC Dose 3 (n=130,127,257)
Title
Measurements
OG0006.15(5.09 to 7.45)
OG0015.67(4.47 to 7.19)
OG0025.91(5.08 to 6.87)
Serotype 19F: After 23vPS Dose (n=130,127,257)
Title
Measurements
OG0006.78(5.65 to 8.14)
OG0015.84(4.62 to 7.39)
OG0026.30(5.44 to 7.30)
Serotype 23F: After 13vPnC Dose 3 (n=132,129,261)
Title
Measurements
OG0006.69(5.60 to 7.98)
OG0017.30(5.87 to 9.09)
OG0026.98(6.07 to 8.03)
Serotype 23F: After 23vPS Dose (n=132,129,261)
Title
Measurements
OG0005.99(5.05 to 7.11)
OG0017.03(5.69 to 8.70)
OG0026.49(5.66 to 7.43)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000133
OG001130
OG002263
Title
Denominators
Categories
Serotype 1 (n = 128, 127, 255)
Title
Measurements
OG0001.08(1.01 to 1.16)
OG0011.02(0.96 to 1.08)
OG0021.05(1.00 to 1.10)
Serotype 3 (n = 124, 118, 242)
Title
Measurements
OG0001.11(1.03 to 1.20)
OG0010.94(0.88 to 1.00)
OG0021.02(0.97 to 1.08)
Serotype 4 (n = 133, 128, 261)
Title
Measurements
OG0001.00(0.94 to 1.05)
OG0010.94(0.90 to 0.99)
OG0020.97(0.94 to 1.01)
Serotype 5 (n = 132, 130, 262)
Title
Measurements
OG0001.07(1.02 to 1.13)
OG0011.12(1.05 to 1.19)
OG0021.09(1.05 to 1.14)
Serotype 6A (n = 122, 129, 251)
Title
Measurements
OG0000.97(0.92 to 1.04)
OG0010.95(0.91 to 0.99)
OG0020.96(0.93 to 1.00)
Serotype 6B (n = 133, 129, 262)
Title
Measurements
OG0000.91(0.87 to 0.95)
OG0011.00(0.96 to 1.04)
OG0020.95(0.92 to 0.98)
Serotype 7F (n = 133, 130, 263)
Title
Measurements
OG0001.02(0.97 to 1.07)
OG0011.01(0.95 to 1.06)
OG0021.01(0.98 to 1.05)
Serotype 9V (n = 133, 130, 263)
Title
Measurements
OG0001.05(1.00 to 1.10)
OG0011.06(1.01 to 1.11)
OG0021.06(1.02 to 1.09)
Serotype 14 (n = 133, 130, 263)
Title
Measurements
OG0000.98(0.91 to 1.06)
OG0011.06(0.99 to 1.13)
OG0021.02(0.97 to 1.07)
Serotype 18C (n = 132, 130, 262)
Title
Measurements
OG0000.92(0.88 to 0.96)
OG0010.93(0.89 to 0.97)
OG0020.92(0.90 to 0.95)
Serotype 19A (n = 133, 130, 263)
Title
Measurements
OG0000.93(0.89 to 0.97)
OG0011.01(0.96 to 1.05)
OG0020.97(0.94 to 1.00)
Serotype 19F (n = 130, 127, 257)
Title
Measurements
OG0001.10(1.04 to 1.17)
OG0011.03(0.97 to 1.09)
OG0021.07(1.02 to 1.11)
Serotype 23F (n = 132, 129, 261)
Title
Measurements
OG0000.90(0.86 to 0.94)
OG0010.96(0.91 to 1.02)
OG0020.93(0.89 to 0.96)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000132
OG001128
OG002260
Title
Denominators
Categories
Serotype 1: After 13vPnC Dose 3 (n=131,125,256)
Title
Measurements
OG00070(53.4 to 93.0)
OG00167(50.2 to 90.6)
OG00269(56.4 to 84.3)
Serotype 1: After 23vPS Dose (n=131,125,256)
Title
Measurements
OG000100(76.6 to 130.3)
OG00166(49.0 to 90.2)
OG00282(66.9 to 100.2)
Serotype 3: After 13vPnC Dose 3 (n=132,128,260)
Title
Measurements
OG000114(94.6 to 136.7)
OG00178(61.3 to 98.7)
OG00294(81.1 to 109.7)
Serotype 3: After 23vPS Dose (n=132,128,260)
Title
Measurements
OG000148(123.9 to 177.3)
OG001103(81.6 to 130.9)
OG002124(107.0 to 144.0)
Serotype 4: After 13vPnC Dose 3 (n=127,126,253)
Title
Measurements
OG0003213(2698.5 to 3826.6)
OG0011888(1427.3 to 2498.1)
OG0022466(2087.0 to 2913.5)
Serotype 4: After 23vPS Dose (n=127,126,253)
Title
Measurements
OG0003553(2984.9 to 4229.7)
OG0011831(1366.0 to 2453.7)
OG0022554(2146.3 to 3038.7)
Serotype 5: After 13vPnC Dose 3 (n=129,124,253)
Title
Measurements
OG000270(197.0 to 370.1)
OG001143(97.5 to 209.6)
OG002198(154.2 to 253.5)
Serotype 5: After 23vPS Dose (n=129,124,253)
Title
Measurements
OG000378(276.5 to 516.9)
OG001186(130.9 to 264.4)
OG002267(210.6 to 338.6)
Serotype 6A: After 13vPnC Dose 3 (n=132,127,259)
Title
Measurements
OG0008011(6580.0 to 9752.1)
OG0012956(2240.1 to 3900.3)
OG0024913(4109.7 to 5873.6)
Serotype 6A: After 23vPS Dose (n=132,127,259)
Title
Measurements
OG0007236(5936.2 to 8819.4)
OG0012707(2060.8 to 3556.3)
OG0024468(3743.3 to 5333.1)
Serotype 6B: After 13vPnC Dose 3 (n=130,126,256)
Title
Measurements
OG0007102(5853.9 to 8615.8)
OG0013666(2720.7 to 4940.5)
OG0025129(4283.9 to 6141.0)
Serotype 6B: After 23vPS Dose (n=130,126,256)
Title
Measurements
OG0006652(5460.8 to 8102.8)
OG0013324(2496.6 to 4426.2)
OG0024728(3961.1 to 5643.2)
Serotype 7F: After 13vPnC Dose 3 (n=131,125,256)
Title
Measurements
OG0004640(3915.9 to 5497.9)
OG0012821(2283.2 to 3484.4)
OG0023639(3171.6 to 4174.8)
Serotype 7F: After 23vPS Dose (n=131,125,256)
Title
Measurements
OG0005260(4470.4 to 6189.9)
OG0013027(2455.7 to 3731.3)
OG0024016(3508.3 to 4597.9)
Serotype 9V: After 13vPnC Dose 3 (n=127,125,252)
Title
Measurements
OG0004501(3606.4 to 5618.0)
OG0011980(1394.6 to 2811.7)
OG0022995(2424.2 to 3700.8)
Serotype 9V: After 23vPS Dose (n=127,125,252)
Title
Measurements
OG0005114(4090.6 to 6393.0)
OG0012037(1452.6 to 2857.6)
OG0023240(2629.5 to 3991.2)
Serotype 14: After 13vPnC Dose 3 (n=127,126,253)
Title
Measurements
OG0004023(3317.5 to 4879.5)
OG0011431(1115.7 to 1836.1)
OG0022405(2030.8 to 2847.1)
Serotype 14: After 23vPS Dose (n=127,126,253)
Title
Measurements
OG0004718(3861.6 to 5764.9)
OG0011620(1284.5 to 2043.0)
OG0022771(2346.9 to 3270.7)
Serotype 18C: After 13vPnC Dose 3 (n=129,121,250)
Title
Measurements
OG0005455(4401.5 to 6761.4)
OG0011667(1172.5 to 2370.8)
OG0023074(2479.2 to 3810.5)
Serotype 18C: After 23vPS Dose (n=129,121,250)
Title
Measurements
OG0006468(5341.1 to 7832.2)
OG0011835(1328.1 to 2535.5)
OG0023515(2878.5 to 4292.8)
Serotype 19A: After 13vPnC Dose 3 (n=131,125,256)
Title
Measurements
OG0001021(837.5 to 1245.6)
OG001603(456.7 to 796.3)
OG002790(665.2 to 937.4)
Serotype 19A: After 23vPS Dose (n=131,125,256)
Title
Measurements
OG0001244(1012.1 to 1529.5)
OG001691(531.0 to 898.6)
OG002933(788.2 to 1105.5)
Serotype 19F: After 13vPnC Dose 3 (n=126,117,243)
Title
Measurements
OG0001166(884.3 to 1537.7)
OG001564(375.0 to 848.1)
OG002822(642.8 to 1051.0)
Serotype 19F: After 23vPS Dose (n=126,117,243)
Title
Measurements
OG0001696(1296.5 to 2217.5)
OG001790(547.5 to 1139.7)
OG0021174(934.2 to 1474.8)
Serotype 23F: After 13vPnC Dose 3 (n=128,126,254)
Title
Measurements
OG0002346(1883.3 to 2922.6)
OG001650(435.3 to 969.9)
OG0021241(976.6 to 1576.7)
Serotype 23F: After 23vPS Dose (n=128,126,254)
Title
Measurements
OG0002595(2143.3 to 3141.5)
OG001580(386.1 to 871.8)
OG0021234(970.1 to 1570.3)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000132
OG001128
OG002260
Title
Denominators
Categories
Serotype 1 (n = 131, 125, 256)
Title
Measurements
OG0001.4(1.23 to 1.63)
OG0011.0(0.86 to 1.13)
OG0021.2(1.08 to 1.31)
Serotype 3 (n = 132, 128, 260)
Title
Measurements
OG0001.3(1.15 to 1.48)
OG0011.3(1.17 to 1.51)
OG0021.3(1.20 to 1.44)
Serotype 4 (n = 127, 126, 253)
Title
Measurements
OG0001.1(1.04 to 1.18)
OG0011.0(0.87 to 1.09)
OG0021.0(0.97 to 1.10)
Serotype 5 (n = 129, 124, 253)
Title
Measurements
OG0001.4(1.15 to 1.71)
OG0011.3(1.13 to 1.50)
OG0021.4(1.20 to 1.53)
Serotype 6A (n = 132, 127, 259)
Title
Measurements
OG0000.9(0.85 to 0.96)
OG0010.9(0.86 to 0.97)
OG0020.9(0.87 to 0.95)
Serotype 6B (n = 130, 126, 256)
Title
Measurements
OG0000.9(0.87 to 1.01)
OG0010.9(0.79 to 1.04)
OG0020.9(0.86 to 0.99)
Serotype 7F (n = 131, 125, 256)
Title
Measurements
OG0001.1(1.06 to 1.21)
OG0011.1(0.93 to 1.23)
OG0021.1(1.02 to 1.19)
Serotype 9V (n = 127, 125, 252)
Title
Measurements
OG0001.1(1.05 to 1.23)
OG0011.0(0.84 to 1.27)
OG0021.1(0.97 to 1.21)
Serotype 14 (n = 127, 126, 253)
Title
Measurements
OG0001.2(1.07 to 1.28)
OG0011.1(1.03 to 1.24)
OG0021.2(1.08 to 1.23)
Serotype 18C (n = 129, 121, 250)
Title
Measurements
OG0001.2(1.04 to 1.35)
OG0011.1(0.92 to 1.31)
OG0021.1(1.03 to 1.27)
Serotype 19A (n = 131, 125, 256)
Title
Measurements
OG0001.2(1.11 to 1.34)
OG0011.1(1.03 to 1.27)
OG0021.2(1.10 to 1.27)
Serotype 19F (n = 126, 117, 243)
Title
Measurements
OG0001.5(1.25 to 1.69)
OG0011.4(1.14 to 1.72)
OG0021.4(1.26 to 1.62)
Serotype 23F (n = 128, 126, 254)
Title
Measurements
OG0001.1(0.96 to 1.28)
OG0010.9(0.81 to 0.98)
OG0021.0(0.91 to 1.09)
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000120
OG001123
OG002243
Title
Denominators
Categories
Redness: Any (n = 92, 88, 180)
Title
Measurements
OG00020.7
OG0012.3
OG00211.7
Redness: Mild (n = 91, 88, 179)
Title
Measurements
OG00019.8
OG0012.3
OG00211.2
Redness: Moderate (n = 85, 88, 173)
Title
Measurements
OG0002.4
OG0010.0
OG0021.2
Redness: Severe (n = 84, 88, 172)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Swelling: Any (n = 97, 94, 191)
Title
Measurements
OG00029.9
OG0019.6
OG00219.9
Swelling: Mild (n = 91, 93, 184)
Title
Measurements
OG00017.6
OG0018.6
OG00213.0
Swelling: Moderate (n = 92, 89, 181)
Title
Measurements
OG00016.3
OG0011.1
OG0028.8
Swelling: Severe (n = 84, 88, 172)
Title
Measurements
OG0001.2
OG0010.0
OG0020.6
Pain at Injection Site: Any (n = 117, 121, 238)
Title
Measurements
OG00068.4
OG00162.8
OG00265.5
Pain at Injection Site: Mild (n = 112, 116, 228)
Title
Measurements
OG00055.4
OG00156.0
OG00255.7
Pain at Injection Site: Moderate (n = 94, 94, 188)
Title
Measurements
OG00028.7
OG00118.1
OG00223.4
Pain at Injection Site: Severe (n = 86, 89, 175)
Title
Measurements
OG0008.1
OG0012.2
OG0025.1
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000120
OG001119
OG002239
Title
Denominators
Categories
Redness: Any (n = 101, 86, 187)
Title
Measurements
OG00013.9
OG0012.3
OG0028.6
Redness: Mild (n = 100, 86, 186)
Title
Measurements
OG00010.0
OG0012.3
OG0026.5
Redness: Moderate (n = 95, 85, 180)
Title
Measurements
OG0004.2
OG0010.0
OG0022.2
Redness: Severe (n = 93, 85, 178)
Title
Measurements
OG0001.1
OG0010.0
OG0020.6
Swelling: Any (n = 103, 88, 191)
Title
Measurements
OG00025.2
OG0018.0
OG00217.3
Swelling: Mild (n = 102, 88, 190)
Title
Measurements
OG00018.6
OG0018.0
OG00213.7
Swelling: Moderate (n = 99, 85, 184)
Title
Measurements
OG00012.1
OG0010.0
OG0026.5
Swelling: Severe (n = 93, 85, 178)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Pain at Injection Site: Any (n = 117, 119, 236)
Title
Measurements
OG00060.7
OG00179.8
OG00270.3
Pain at Injection Site: Mild (n = 110, 117, 227)
Title
Measurements
OG00049.1
OG00172.6
OG00261.2
Pain at Injection Site: Moderate (n= 103, 96, 199)
Title
Measurements
OG00024.3
OG00127.1
OG00225.6
Pain at Injection Site: Severe (n = 93, 86, 179)
Title
Measurements
OG0005.4
OG0013.5
OG0024.5
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000104
OG001109
OG002213
Title
Denominators
Categories
Redness: Any (n = 84, 70, 154)
Title
Measurements
OG0008.3
OG0010.0
OG0024.5
Redness: Mild (n = 83, 70, 153)
Title
Measurements
OG0007.2
OG0010.0
OG0023.9
Redness: Moderate (n = 82, 70, 152)
Title
Measurements
OG0002.4
OG0010.0
OG0021.3
Redness: Severe (n = 80, 70, 150)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Swelling: Any (n = 89, 71, 160)
Title
Measurements
OG00018.0
OG0014.2
OG00211.9
Swelling: Mild (n = 86, 71, 157)
Title
Measurements
OG00010.5
OG0014.2
OG0027.6
Swelling: Moderate (n = 84, 70, 154)
Title
Measurements
OG0009.5
OG0010.0
OG0025.2
Swelling: Severe (n = 80, 70, 150)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
Pain at Injection Site: Any (n = 104, 109, 213)
Title
Measurements
OG00052.9
OG00169.7
OG00261.5
Pain at Injection Site: Mild (n = 96, 105, 201)
Title
Measurements
OG00041.7
OG00163.8
OG00253.2
Pain at Injection Site: Moderate (n = 89, 78, 167)
Title
Measurements
OG00019.1
OG00124.4
OG00221.6
Pain at Injection Site: Severe (n = 83, 73, 156)
Title
Measurements
OG0004.8
OG0015.5
OG0025.1
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000128
OG001138
OG002266
Title
Denominators
Categories
Fever: >=38 degrees C (n= 94, 95, 189)
Title
Measurements
OG00019.1
OG00117.9
OG00218.5
Fever: >=38, <38.5 degrees C (n = 87, 92, 179)
Title
Measurements
OG0008.0
OG0018.7
OG0028.4
Fever: >=38.5, <39 degrees C (n = 85, 89, 174)
Title
Measurements
OG0002.4
OG0013.4
OG0022.9
Fever: >=39, =<40 degrees C (n = 86, 88, 174)
Title
Measurements
OG0004.7
OG0012.3
OG0023.4
Fever: >40 degrees C (n = 88, 93, 181)
Title
Measurements
OG0006.8
OG0018.6
OG0027.7
Fatigue: Any (n = 111, 119, 230)
Title
Measurements
OG00047.7
OG00158.8
OG00253.5
Fatigue: Mild (n = 105, 113, 218)
Title
Measurements
OG00033.3
OG00151.3
OG00242.7
Fatigue: Moderate (n = 96, 99, 195)
Title
Measurements
OG00026.0
OG00128.3
OG00227.2
Fatigue: Severe (n = 86, 92, 178)
Title
Measurements
OG0009.3
OG0018.7
OG0029.0
Headache: Any (n = 107, 113, 220)
Title
Measurements
OG00039.3
OG00161.1
OG00250.5
Headache: Mild (n = 100, 109, 209)
Title
Measurements
OG00033.0
OG00157.8
OG00245.9
Headache: Moderate (n = 94, 97, 191)
Title
Measurements
OG00018.1
OG00122.7
OG00220.4
Headache: Severe (n = 87, 89, 176)
Title
Measurements
OG0006.9
OG0019.0
OG0028.0
Vomiting: Any (n = 89, 91, 180)
Title
Measurements
OG00018.0
OG0017.7
OG00212.8
Vomiting: Mild (n = 89, 91, 180)
Title
Measurements
OG00014.6
OG0017.7
OG00211.1
Vomiting: Moderate (n = 84, 88, 172)
Title
Measurements
OG0002.4
OG0010.0
OG0021.2
Vomiting: Severe (n = 85, 88, 173)
Title
Measurements
OG0002.4
OG0010.0
OG0021.2
Diarrhea: Any (n = 94, 105, 199)
Title
Measurements
OG00025.5
OG00134.3
OG00230.2
Diarrhea: Mild (n = 92, 104, 196)
Title
Measurements
OG00019.6
OG00129.8
OG00225.0
Diarrhea: Moderate (n = 86, 91, 177)
Title
Measurements
OG0008.1
OG0017.7
OG0027.9
Diarrhea: Severe (n = 85, 88, 173)
Title
Measurements
OG0001.2
OG0011.1
OG0021.2
Muscle Pain: Any (n = 108, 118, 226)
Title
Measurements
OG00048.1
OG00162.7
OG00255.8
Muscle Pain: Mild (n = 103, 110, 213)
Title
Measurements
OG00036.9
OG00156.4
OG00246.9
Muscle Pain: Moderate (n = 89, 98, 187)
Title
Measurements
OG00019.1
OG00119.4
OG00219.3
Muscle Pain: Severe (n = 86, 91, 177)
Title
Measurements
OG0005.8
OG0015.5
OG0025.6
Joint Pain: Any (n = 100, 105, 205)
Title
Measurements
OG00034.0
OG00142.9
OG00238.5
Joint Pain: Mild (n = 98, 101, 199)
Title
Measurements
OG00026.5
OG00136.6
OG00231.7
Joint Pain: Moderate (n = 89, 95, 184)
Title
Measurements
OG00012.4
OG00117.9
OG00215.2
Joint Pain: Severe (n = 84, 91, 175)
Title
Measurements
OG0004.8
OG0014.4
OG0024.6
Use of Medication to Treat Pain (n = 101, 96, 197)
Title
Measurements
OG00033.7
OG00124.0
OG00228.9
Use of Medication to Treat Fever (n=112, 107, 219)
Title
Measurements
OG00044.6
OG00139.3
OG00242.0
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000123
OG001120
OG002243
Title
Denominators
Categories
Fever: >=38 degrees C (n= 102, 88, 190)
Title
Measurements
OG00016.7
OG00111.4
OG00214.2
Fever: >=38, <38.5 degrees C (n = 96, 87, 183)
Title
Measurements
OG0007.3
OG0019.2
OG0028.2
Fever: >=38.5, <39 degrees C (n = 98, 85, 183)
Title
Measurements
OG0006.1
OG0011.2
OG0023.8
Fever: >=39, =<40 degrees C (n = 97, 87, 184)
Title
Measurements
OG0007.2
OG0013.4
OG0025.4
Fever: >40 degrees C (n = 95, 85, 180)
Title
Measurements
OG0001.1
OG0011.2
OG0021.1
Fatigue: Any (n = 106, 105, 211)
Title
Measurements
OG00033.0
OG00148.6
OG00240.8
Fatigue: Mild (n = 104, 103, 207)
Title
Measurements
OG00024.0
OG00142.7
OG00233.3
Fatigue: Moderate (n = 96, 88, 184)
Title
Measurements
OG00010.4
OG00121.6
OG00215.8
Fatigue: Severe (n = 95, 88, 183)
Title
Measurements
OG0007.4
OG0015.7
OG0026.6
Headache: Any (n = 101, 106, 207)
Title
Measurements
OG00028.7
OG00149.1
OG00239.1
Headache: Mild (n = 97, 102, 199)
Title
Measurements
OG00018.6
OG00140.2
OG00229.6
Headache: Moderate (n = 97, 93, 190)
Title
Measurements
OG00013.4
OG00128.0
OG00220.5
Headache: Severe (n = 94, 88, 182)
Title
Measurements
OG0002.1
OG0013.4
OG0022.7
Vomiting: Any (n = 96, 89, 185)
Title
Measurements
OG00010.4
OG00110.1
OG00210.3
Vomiting: Mild (n = 94, 89, 183)
Title
Measurements
OG0006.4
OG0019.0
OG0027.7
Vomiting: Moderate (n = 94, 85, 179)
Title
Measurements
OG0003.2
OG0011.2
OG0022.2
Vomiting: Severe (n = 94, 85, 179)
Title
Measurements
OG0003.2
OG0010.0
OG0021.7
Diarrhea: Any (n = 95, 95, 190)
Title
Measurements
OG00010.5
OG00126.3
OG00218.4
Diarrhea: Mild (n = 94, 93, 187)
Title
Measurements
OG0007.4
OG00124.7
OG00216.0
Diarrhea: Moderate (n = 93, 87, 180)
Title
Measurements
OG0003.2
OG0018.0
OG0025.6
Diarrhea: Severe (n = 94, 85, 179)
Title
Measurements
OG0004.3
OG0011.2
OG0022.8
Muscle Pain: Any (n = 112, 104, 216)
Title
Measurements
OG00037.5
OG00152.9
OG00244.9
Muscle Pain: Mild (n = 105, 103, 208)
Title
Measurements
OG00025.7
OG00146.6
OG00236.1
Muscle Pain: Moderate (n = 100, 91, 191)
Title
Measurements
OG00015.0
OG00120.9
OG00217.8
Muscle Pain: Severe (n = 95, 85, 180)
Title
Measurements
OG0005.3
OG0012.4
OG0023.9
Joint Pain: Any (n = 106, 95, 201)
Title
Measurements
OG00026.4
OG00134.7
OG00230.3
Joint Pain: Mild (n = 100, 93, 193)
Title
Measurements
OG00016.0
OG00129.0
OG00222.3
Joint Pain: Moderate (n = 99, 89, 188)
Title
Measurements
OG00011.1
OG00112.4
OG00211.7
Joint Pain: Severe (n = 94, 85, 179)
Title
Measurements
OG0004.3
OG0012.4
OG0023.4
Use of Medication to Treat Pain (n = 100, 91, 191)
Title
Measurements
OG00020.0
OG00117.6
OG00218.8
Use of Medication to Treat Fever (n=102, 96, 198)
Title
Measurements
OG00028.4
OG00126.0
OG00227.3
OG001
13vPnC, 23vPS (Adult Participants)
Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
OG002
13vPnC, 23vPS (All Participants)
Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Units
Counts
Participants
OG000106
OG001113
OG002219
Title
Denominators
Categories
Fever: >=38 degrees C (n= 85, 73, 158)
Title
Measurements
OG00010.6
OG00111.0
OG00210.8
Fever: >=38, <38.5 degrees C (n = 82, 73, 155)
Title
Measurements
OG0006.1
OG0015.5
OG0025.8
Fever: >=38.5, <39 degrees C (n = 81, 72, 153)
Title
Measurements
OG0002.5
OG0015.6
OG0023.9
Fever: >=39, =<40 degrees C (n = 82, 70, 152)
Title
Measurements
OG0002.4
OG0012.9
OG0022.6
Fever: >40 degrees C (n = 83, 70, 153)
Title
Measurements
OG0003.6
OG0011.4
OG0022.6
Fatigue: Any (n = 92, 91, 183)
Title
Measurements
OG00025.0
OG00147.3
OG00236.1
Fatigue: Mild (n = 89, 88, 177)
Title
Measurements
OG00020.2
OG00139.8
OG00229.9
Fatigue: Moderate (n = 83, 80, 163)
Title
Measurements
OG0006.0
OG00125.0
OG00215.3
Fatigue: Severe (n = 83, 73, 156)
Title
Measurements
OG0004.8
OG0018.2
OG0026.4
Headache: Any (n = 88, 89, 177)
Title
Measurements
OG00018.2
OG00146.1
OG00232.2
Headache: Mild (n = 84, 87, 171)
Title
Measurements
OG00010.7
OG00141.4
OG00226.3
Headache: Moderate (n = 83, 77, 160)
Title
Measurements
OG0008.4
OG00119.5
OG00213.8
Headache: Severe (n = 82, 72, 154)
Title
Measurements
OG0003.7
OG0016.9
OG0025.2
Vomiting: Any (n = 85, 74, 159)
Title
Measurements
OG0008.2
OG0019.5
OG0028.8
Vomiting: Mild (n = 84, 72, 156)
Title
Measurements
OG0007.1
OG0015.6
OG0026.4
Vomiting: Moderate (n = 82, 73, 155)
Title
Measurements
OG0002.4
OG0015.5
OG0023.9
Vomiting: Severe (n = 81, 72, 153)
Title
Measurements
OG0001.2
OG0012.8
OG0022.0
Diarrhea: Any (n = 81, 81, 162)
Title
Measurements
OG0004.9
OG00128.4
OG00216.7
Diarrhea: Mild (n = 81, 79, 160)
Title
Measurements
OG0004.9
OG00125.3
OG00215.0
Diarrhea: Moderate (n = 80, 73, 153)
Title
Measurements
OG0001.3
OG0016.8
OG0023.9
Diarrhea: Severe (n = 81, 73, 154)
Title
Measurements
OG0001.2
OG0014.1
OG0022.6
Muscle Pain: Any (n = 99, 92, 191)
Title
Measurements
OG00037.4
OG00147.8
OG00242.4
Muscle Pain: Mild (n = 93, 89, 182)
Title
Measurements
OG00025.8
OG00137.1
OG00231.3
Muscle Pain: Moderate (n = 85, 78, 163)
Title
Measurements
OG00012.9
OG00124.4
OG00218.4
Muscle Pain: Severe (n = 84, 72, 156)
Title
Measurements
OG0008.3
OG0015.6
OG0027.1
Joint Pain: Any (n = 91, 83, 174)
Title
Measurements
OG00024.2
OG00132.5
OG00228.2
Joint Pain: Mild (n = 88, 82, 170)
Title
Measurements
OG00015.9
OG00128.0
OG00221.8
Joint Pain: Moderate (n = 82, 77, 159)
Title
Measurements
OG0007.3
OG00115.6
OG00211.3
Joint Pain: Severe (n = 81, 71, 152)
Title
Measurements
OG0002.5
OG0012.8
OG0022.6
Use of Medication to Treat Pain (n = 90, 79, 169)
Title
Measurements
OG00017.8
OG00121.5
OG00219.5
Use of Medication to Treat Fever (n = 89, 75, 164)