Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Official Title
A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2015
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
Sep 2007
Primary Completion Date
Dec 2013Actual
Completion Date
Dec 2013Actual
First Submitted Date
Aug 24, 2007
First Submission Date that Met QC Criteria
Aug 27, 2007
First Posted Date
Aug 28, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2014
Results First Submitted that Met QC Criteria
Apr 7, 2015
Results First Posted Date
Apr 9, 2015Estimated
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
Apr 7, 2015
Last Update Posted Date
Apr 9, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Pneumococcal Conjugate Vaccine
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
1,116Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Other
arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.
1 month after Dose 1
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult 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 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
1 month after 13vPnC Dose at year 0
Secondary Outcomes
Not provided
Other Outcomes
Measure
Description
Time Frame
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female aged 50 to 59 years
Determined by medical history, physical examination and clinical judgement to be eligible for the study
Able to complete electronic diary
Available for the 5 year 9 month duration of the study
Exclusion Criteria:
Previous vaccination with any licensed or experimental pneumococcal vaccine
Allergic to egg proteins and chicken proteins
History of Guillian-Barre syndrome
Vaccination with TIV within 6 months before study start
Vaccination with diphtheria-containing vaccine within 6 months of study start
Serious chronic disorders including immunodeficiency or metastatic malignancy
Known or suspected hypersensitivity to any vaccine or vaccine component
Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.
Initially 1060 participants were reported to complete the 6 month follow up at Year 0, however 6 additional participants who were reported to have withdrawn initially, actually completed the 6 month follow up at Year 0.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Periods
Title
Milestones
Reasons Not Completed
Initial Vaccination (Year 0)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle
13 valent pneumococcal conjugate vaccine
Biological
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
2
0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle
1 month after 13vPnC (Year 5)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.
before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
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 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 before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.
Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.
Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult 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 1 month after 13vPnC Dose 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
1 month after 13vPnC (Year 5)
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.
before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.
Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)
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(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Within 14 days after Dose 1 (Year 0)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)
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(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Within 14 days after Dose 2 (Year 0)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)
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(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
Within 14 days after 13vPnC (Year 5)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)
Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
Within 14 days after Dose 1 (Year 0)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)
Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
Within 14 days after Dose 2 (Year 0)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)
Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
Within 14 days after 13vPnC (Year 5)
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)
Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Within 30 Minutes After Dose 1 (Year 0)
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)
Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Within 30 Minutes After Dose 2 (Year 0)
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)
Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
Within 30 Minutes After 13vPnC (Year 5)
Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.
Signing of informed consent up to 194 days after re-vaccination at Year 5
Rolling Hills Estates
California
90274
United States
Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
Aurora
Colorado
80045-7144
United States
Tampa Bay Medical Research, Inc.
Clearwater
Florida
33761
United States
A. G. A. Clinical Trials
Hialeah
Florida
33012
United States
Advanced Clinical Research
Meridian
Idaho
83642
United States
Accelovance
Peoria
Illinois
61602
United States
Suite 100
Riverdale
Maryland
20737
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Radiant Research, Inc
St Louis
Missouri
63141
United States
Big Sky Clinical Research
Butte
Montana
59701
United States
FFM Clinical Research
Camillus
New York
13031
United States
Rochester Clinical Research
Rochester
New York
14609
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
PMG Research of Raleigh, LLC
Cary
North Carolina
27518
United States
Hickory Family Practice Associates
Hickory
North Carolina
28601
United States
PMG Research of Hickory, LLC
Hickory
North Carolina
28601
United States
Unifour Medical Research Associates, LLC
Hickory
North Carolina
28601
United States
Unifour Medical Research Associates
Hickory
North Carolina
28601
United States
Fairbrook Medical Clinic
Hickory
North Carolina
28602
United States
PMG Research of Hickory, LLC
Hickory
North Carolina
28602
United States
Unifour Medical Research Associates, LLC
Hickory
North Carolina
28602
United States
PMG Research of Raleigh, LLC
Raleigh
North Carolina
27609
United States
PMG Research of Salisbury
Salisbury
North Carolina
28144
United States
PMG Research of Winston-Salem
Winston-Salem
North Carolina
27103
United States
Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
Cincinnati
Ohio
45206
United States
Rapid Medical Research, Inc.
Cleveland
Ohio
44122
United States
Prestige Clinical Research
Franklin
Ohio
45005
United States
Preferred Primary Care Physicians, Inc
Carnegie
Pennsylvania
15106
United States
Family Healthcare Partners
Grove City
Pennsylvania
16127
United States
Family Practice Medical Associates South, Jefferson Office
Jefferson Hills
Pennsylvania
15025
United States
Kid's Plus Pediatrics
Pittsburgh
Pennsylvania
15217
United States
Primary Physicians Research Inc.
Pittsburgh
Pennsylvania
15241
United States
Family Practice Medical Associates South
Upper Saint Clair
Pennsylvania
15241
United States
The Washington Hospital Family Medicine
Washington
Pennsylvania
15301
United States
Internal Medicine & Pediatric Associates of Bristol, PC
Bristol
Tennessee
37620
United States
PMG Research of Bristol, LLC
Bristol
Tennessee
37620
United States
Volunteer Research Group
Knoxville
Tennessee
37920
United States
Clark D. McKeever, M.D. Research for Health
Houston
Texas
77055-6040
United States
Diagnostics Research Group
San Antonio
Texas
78229
United States
Advanced Clinical Research
West Jordan
Utah
84088
United States
Derived
Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.
FG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
FG000554 subjects
FG001562 subjects
Vaccinated Dose 1
FG000551 subjects
FG001560 subjects
Vaccinated Dose 2
FG000538 subjects
FG001543 subjects
Initially Reported to Complete Year 0
FG000531 subjectsInitially 1060 participants were reported to complete follow-up(Year 0),but 1066 actually completed.
FG001529 subjectsInitially 1060 participants were reported to complete follow-up(Year 0),but 1066 actually completed.
COMPLETED
FG000533 subjects6 additional participants initially reported to have withdrawn, actually completed follow-up(Year 0)
FG001533 subjects6 additional participants initially reported to have withdrawn, actually completed follow-up(Year 0)
NOT COMPLETED
FG00021 subjects
FG00129 subjects
Type
Comment
Reasons
Subject request
FG0008 subjects
FG00111 subjects
Lost to Follow-up
FG0005 subjects
FG00110 subjects
Protocol Violation
FG0002 subjects
FG0015 subjects
Other, unspecified
FG0003 subjects
FG0011 subjects
Investigator request
FG0002 subjects
FG0010 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
Death
FG0001 subjects
FG0010 subjects
Failed to return
FG0000 subjects
FG0011 subjects
Follow-up (From 6-month[Year 0]-Year 5)
Type
Comment
Milestone Data
STARTED
FG000533 subjects
FG001533 subjects
COMPLETED
FG000364 subjects
FG001363 subjects
NOT COMPLETED
FG000169 subjects
FG001170 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0011 subjects
Death
FG0005 subjects
FG001
Revaccination With 13vPnC (Year 5)
Type
Comment
Milestone Data
STARTED
FG000364 subjects
FG001363 subjects
Vaccinated 13vPnC (Year 5)
FG000364 subjects
FG001363 subjects
Completed 1 Month Follow-up
FG000363 subjects
FG001359 subjects
Completed 6 Month Follow-up
FG000361 subjects
FG001351 subjects
COMPLETED
FG000361 subjects
FG001351 subjects
NOT COMPLETED
FG0003 subjects
FG00112 subjects
Type
Comment
Reasons
Subject request
FG0000 subjects
FG0011 subjects
Failed to return
FG0001 subjects
FG001
Safety analysis set included all randomized participants who had received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
BG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000551
BG001560
BG0021111
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
BG00054.6± 2.8
BG00154.6± 2.9
BG00254.6± 2.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000319
BG001322
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
Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.
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.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after Dose 1
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000530
OG001531
Title
Denominators
Categories
A/H1N1 strain (n=445,431)
Title
Measurements
OG00084.0(80.6 to 87.0)
OG00181.2(77.6 to 84.4)
A/H3N2 strain (n=377,369)
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang
percent difference
2.8
2-Sided
95
-1.8
7.4
Yes
Non-Inferiority or Equivalence
Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult 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 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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=participants with valid and determinate assay results for the specified serotype at the given visit.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter (mcg/mL)
1 month after 13vPnC Dose at year 0
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
titers
1 month after 13vPnC (Year 5)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
Other Pre-specified
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.
All-available immunogenicity population at Year 5.n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
titers
before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Year 0 and 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.
Posted
Geometric Mean
95% Confidence Interval
titers
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both 1 month after 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
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 participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
titers
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
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 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 before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.
Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window.
Posted
Geometric Mean
95% Confidence Interval
titers
Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.
Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and all the specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult 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 1 month after 13vPnC Dose 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter(mcg/mL)
1 month after 13vPnC (Year 5)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
Other Pre-specified
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.
All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Years 0 through Year 5 within the protocol specified time window. Here, n=number of participants with valid and determinate assay results for the specified serotype at the given time points.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)
ID
Title
Description
OG000
All Participants
Other Pre-specified
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.
Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and the specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
fold-rises
Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)
ID
Title
Description
OG000
All Participants
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)
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(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.
Posted
Number
percentage of participants
Within 14 days after Dose 1 (Year 0)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)
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(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here,n=number of participants with known values.
Posted
Number
percentage of participants
Within 14 days after Dose 2 (Year 0)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)
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(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).
The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.
Posted
Number
percentage of participants
Within 14 days after 13vPnC (Year 5)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)
Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.
Posted
Number
percentage of participants
Within 14 days after Dose 1 (Year 0)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)
Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.
Posted
Number
percentage of participants
Within 14 days after Dose 2 (Year 0)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)
Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.
The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.
Posted
Number
percentage of participants
Within 14 days after 13vPnC (Year 5)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)
Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Safety population included all participants who had received at least 1 vaccination and did not lack any safety data.
Posted
Number
percentage of participants
Within 30 Minutes After Dose 1 (Year 0)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)
Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.
Safety population included all participants who had received at least 1 vaccination (Dose 2, year 0) and did not lack any safety data.
Posted
Number
percentage of participants
Within 30 Minutes After Dose 2 (Year 0)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Other Pre-specified
Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)
Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).
Safety population at Year 5 included all participants who had received at least 1 vaccination and did not lack any safety data.
Posted
Number
percentage of participants
Within 30 Minutes After 13vPnC (Year 5)
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
OG001
Other Pre-specified
Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.
Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.
Posted
Number
percentage of participants
Signing of informed consent up to 194 days after re-vaccination at Year 5
ID
Title
Description
OG000
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)
Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Time Frame
AEs/SAEs recorded: All AEs for 1 month postvaccination. All SAEs and newly diagnosed chronic medical conditions for 6 months postvaccination. Deaths and withdrawals due to S/AE in Years 1-4
Description
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
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
13vPnC+TIV/Placebo: Dose 1 (Year 0)
Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
4
551
420
551
EG001
13vPnC+TIV/Placebo: Dose 2 (Year 0)
Participants who received 0.5-mL Placebo matched to 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
3
538
248
538
EG002
13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)
Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
18
538
26
538
EG003
13vPnC+TIV/Placebo: Years 1-4
Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
8
536
1
536
EG004
13vPnC+TIV/Placebo: 13vPnC (Year 5)
Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
2
364
256
364
EG005
13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)
Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
2
364
1
364
EG006
Placebo+TIV/13vPnC: Dose 1 (Year 0)
Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
5
560
326
560
EG007
Placebo+TIV/13vPnC: Dose 2 (Year 0)
Participants who received 0.5-mL dose of 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
6
543
388
543
EG008
Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)
Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
10
543
29
543
EG009
Placebo+TIV/13vPnC: Years 1-4
Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
3
542
0
542
EG010
Placebo+TIV/13vPnC: 13vPnC (Year 5)
Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
2
363
248
363
EG011
Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)
Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
3
363
0
363
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Renal colic
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG0030 affected536 at risk
EG0040 affected364 at risk
EG0050 affected364 at risk
EG0060 affected560 at risk
EG0070 affected543 at risk
EG0080 affected543 at risk
EG0090 affected542 at risk
EG0100 affected363 at risk
EG0111 affected363 at risk
Uterine prolapse
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Thrombosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Blood glucose increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0022 affected538 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Peridiverticular abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0022 affected538 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Leiomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Bone cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Thyroid cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG0030 affected536 at risk
EG0040 affected364 at risk
EG0050 affected364 at risk
EG0060 affected560 at risk
EG0071 affected543 at risk
EG0080 affected543 at risk
EG0090 affected542 at risk
EG0100 affected363 at risk
EG0110 affected363 at risk
Anaemia macrocytic
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Eye irritation
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Eye swelling
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Glaucoma
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Coeliac disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Rectal fissure
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rectal polyp
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0013 affected538 at risk
EG0020 affected538 at risk
EG003
Aggravated generalized joint pain: any
General disorders
Systemic Events
Systematic Assessment
EG00062 affected292 at risk
EG00141 affected264 at risk
EG0020 affected538 at risk
EG003
Aggravated generalized muscle pain: any
General disorders
Systemic Events
Systematic Assessment
EG000109 affected314 at risk
EG00150 affected268 at risk
EG0020 affected538 at risk
EG003
Any systemic event
General disorders
Systemic Events
Systematic Assessment
EG000417 affected484 at risk
EG001248 affected381 at risk
EG0020 affected538 at risk
EG003
Chills
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Chills: any
General disorders
Systemic Events
Systematic Assessment
EG00096 affected306 at risk
EG00156 affected273 at risk
EG0020 affected538 at risk
EG003
Cyst
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Decreased appetite: any
General disorders
Systemic Events
Systematic Assessment
EG00095 affected315 at risk
EG00155 affected270 at risk
EG0020 affected538 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Fatigue: any
General disorders
Systemic Events
Systematic Assessment
EG000226 affected389 at risk
EG001138 affected316 at risk
EG0020 affected538 at risk
EG003
Fever: > 40.0 degrees C
General disorders
Systemic Events
Systematic Assessment
EG0000 affected261 at risk
EG0011 affected237 at risk
EG0020 affected538 at risk
EG003
Fever: 38.0 to 38.5 degrees C
General disorders
Systemic Events
Systematic Assessment
EG0004 affected261 at risk
EG0013 affected238 at risk
EG0020 affected538 at risk
EG003
Fever: 38.5 to 39.0 degrees C
General disorders
Systemic Events
Systematic Assessment
EG0004 affected262 at risk
EG0013 affected239 at risk
EG0020 affected538 at risk
EG003
Fever: 39.0 to 40.0 degrees C
General disorders
Systemic Events
Systematic Assessment
EG0001 affected261 at risk
EG0011 affected236 at risk
EG0020 affected538 at risk
EG003
Headache: any
General disorders
Systemic Events
Systematic Assessment
EG000263 affected399 at risk
EG001161 affected334 at risk
EG0020 affected538 at risk
EG003
Influenza like illness
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site haematoma
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site movement impairment
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site nodule
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Malaise
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
New joint pain: any
General disorders
Systemic Events
Systematic Assessment
EG000102 affected309 at risk
EG00155 affected268 at risk
EG0020 affected538 at risk
EG003
New muscle pain: any
General disorders
Systemic Events
Systematic Assessment
EG000252 affected385 at risk
EG00182 affected288 at risk
EG0020 affected538 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rash: any
General disorders
Systemic Events
Systematic Assessment
EG00035 affected278 at risk
EG00115 affected246 at risk
EG0020 affected538 at risk
EG003
Vessel puncture site reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Vomiting: any
General disorders
Systemic Events
Systematic Assessment
EG00014 affected266 at risk
EG00117 affected247 at risk
EG0020 affected538 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0021 affected538 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Localised infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected551 at risk
EG0014 affected538 at risk
EG0020 affected538 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0022 affected538 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rash pustular
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0011 affected538 at risk
EG0021 affected538 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected551 at risk
EG0017 affected538 at risk
EG0020 affected538 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0011 affected538 at risk
EG0021 affected538 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Blood glucose increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Blood pressure increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Heart rate increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
International normalised ratio decreased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Impaired fasting glucose
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0013 affected538 at risk
EG0020 affected538 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0004 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0012 affected538 at risk
EG0021 affected538 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Morton's neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0014 affected538 at risk
EG0020 affected538 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Presyncope
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected551 at risk
EG0012 affected538 at risk
EG0020 affected538 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0013 affected538 at risk
EG0020 affected538 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected551 at risk
EG0013 affected538 at risk
EG0020 affected538 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected551 at risk
EG0013 affected538 at risk
EG0020 affected538 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0014 affected538 at risk
EG0020 affected538 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0022 affected538 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Any local reaction
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000420 affected474 at risk
EG001105 affected300 at risk
EG0020 affected538 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0011 affected538 at risk
EG0020 affected538 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Limitation of arm movement: Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000113 affected317 at risk
EG00123 affected248 at risk
EG0020 affected538 at risk
EG003
Limitation of arm movement: Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000101 affected310 at risk
EG00123 affected248 at risk
EG0020 affected538 at risk
EG003
Limitation of arm movement: Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00014 affected269 at risk
EG0011 affected236 at risk
EG0020 affected538 at risk
EG003
Limitation of arm movement: Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0009 affected266 at risk
EG0010 affected236 at risk
EG0020 affected538 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Pain: Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000407 affected469 at risk
EG00194 affected294 at risk
EG0020 affected538 at risk
EG003
Pain: Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000380 affected459 at risk
EG00189 affected290 at risk
EG0020 affected538 at risk
EG003
Pain: Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG000127 affected324 at risk
EG00111 affected243 at risk
EG0020 affected538 at risk
EG003
Pain: Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00011 affected267 at risk
EG0010 affected236 at risk
EG0020 affected538 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Redness: Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00046 affected282 at risk
EG0014 affected238 at risk
EG0020 affected538 at risk
EG003
Redness: Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00044 affected281 at risk
EG0014 affected238 at risk
EG0020 affected538 at risk
EG003
Redness: Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00011 affected265 at risk
EG0010 affected236 at risk
EG0020 affected538 at risk
EG003
Redness: Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0001 affected262 at risk
EG0010 affected236 at risk
EG0020 affected538 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Swelling: Any
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00053 affected288 at risk
EG00111 affected242 at risk
EG0020 affected538 at risk
EG003
Swelling: Mild
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00049 affected288 at risk
EG00111 affected242 at risk
EG0020 affected538 at risk
EG003
Swelling: Moderate
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG00015 affected263 at risk
EG0011 affected236 at risk
EG0020 affected538 at risk
EG003
Swelling: Severe
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
EG0001 affected262 at risk
EG0010 affected236 at risk
EG0020 affected538 at risk
EG003
Menopause
Social circumstances
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Flushing
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0021 affected538 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0023 affected538 at risk
EG003
Skin and subcutaneous tissue disorder
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Acute pain at injection site (Mild)
General disorders
MedDRA
Non-systematic Assessment
EG00037 affected551 at risk
EG00132 affected538 at risk
EG0020 affected538 at risk
EG003
Acute Pain at injection site (Moderate)
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Acute Pain at injection site (Severe)
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected551 at risk
EG0010 affected538 at risk
EG0020 affected538 at risk
EG003
Acute Pain at injection site (Any)
General disorders
MedDRA
Non-systematic Assessment
EG00037 affected551 at risk
EG00132 affected538 at risk
EG0020 affected538 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
Failed to return
FG0007 subjects
FG0013 subjects
Investigator request
FG0003 subjects
FG0013 subjects
Lost to Follow-up
FG00055 subjects
FG00156 subjects
Other
FG00022 subjects
FG00126 subjects
Protocol Violation
FG00018 subjects
FG00122 subjects
Subject request
FG00054 subjects
FG00157 subjects
4 subjects
Lost to Follow-up
FG0002 subjects
FG0017 subjects
641
Male
BG000232
BG001238
BG002470
71.1
(67.1 to 75.0)
OG00169.5(65.4 to 73.4)
B strain (n=321,320)
Title
Measurements
OG00060.6(56.3 to 64.8)
OG00160.3(56.0 to 64.5)
OG000
OG001
A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.
percent difference
1.6
2-Sided
95
-3.9
7.2
Yes
Non-Inferiority or Equivalence
Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%
OG000
OG001
B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.
percent difference
0.3
2-Sided
95
-5.6
6.2
Yes
Non-Inferiority or Equivalence
Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000531
OG001532
Title
Denominators
Categories
Serotype 1 (n=292, 289)
Title
Measurements
OG0004.05(3.41 to 4.81)
OG0015.45(4.57 to 6.49)
Serotype 3 (n=290, 288)
Title
Measurements
OG0001.15(1.02 to 1.29)
OG0011.46(1.29 to 1.65)
Serotype 4 (n=290, 288)
Title
Measurements
OG0002.35(2.00 to 2.77)
OG0013.41(2.89 to 4.02)
Serotype 5 (n=293, 289)
Title
Measurements
OG0006.03(5.16 to 7.05)
OG0017.18(6.13 to 8.40)
Serotype 6A (n=293, 288)
Title
Measurements
OG0005.78(5.02 to 6.64)
OG0016.70(5.74 to 7.83)
Serotype 6B (n=292, 289)
Title
Measurements
OG0007.58(6.54 to 8.78)
OG00110.09(8.57 to 11.86)
Serotype 7F (n=293, 289)
Title
Measurements
OG0008.14(7.07 to 9.38)
OG00110.57(9.11 to 12.27)
Serotype 9V (n=293, 289)
Title
Measurements
OG0004.96(4.32 to 5.70)
OG0016.97(6.08 to 7.99)
Serotype 14 (n=294, 288)
Title
Measurements
OG00010.77(9.04 to 12.82)
OG00114.05(11.82 to 16.71)
Serotype 18C (n=293, 288)
Title
Measurements
OG0009.65(8.32 to 11.19)
OG00113.49(11.62 to 15.67)
Serotype 19A (n=294, 289)
Title
Measurements
OG00016.80(14.75 to 19.14)
OG00118.84(16.37 to 21.68)
Serotype 19F (n=291, 286)
Title
Measurements
OG0006.13(5.21 to 7.22)
OG0017.13(5.90 to 8.63)
Serotype 23F (n=294, 289)
Title
Measurements
OG0007.17(6.06 to 8.49)
OG0018.54(7.11 to 10.25)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.74
2-Sided
95
0.58
0.95
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.79
2-Sided
95
0.66
0.93
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.69
2-Sided
95
0.55
0.87
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.84
2-Sided
95
0.67
1.05
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.86
2-Sided
95
0.70
1.06
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.75
2-Sided
95
0.60
0.93
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric mean ratio
0.77
2-Sided
95
0.63
0.95
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution
Geometric mean ratio
0.71
2-Sided
95
0.59
0.86
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution
Geometric Mean Ratio
0.77
2-Sided
95
0.60
0.98
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution
Geometric Mean Ratio
0.72
2-Sided
95
0.58
0.88
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution
Geometric Mean Ratio
0.89
2-Sided
95
0.74
1.08
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution
Geometric Mean Ratio
0.86
2-Sided
95
0.67
1.10
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG000
OG001
Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution
Geometric Mean Ratio
0.84
2-Sided
95
0.66
1.08
Yes
Non-Inferiority or Equivalence
Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000363
OG001363
Title
Denominators
Categories
Serotype 1 (n=349,352 )
Title
Measurements
OG000178(150.6 to 210.1)
OG001168(141.4 to 199.9)
Serotype 3(n=355, 352)
Title
Measurements
OG00059(52.1 to 67.1)
OG00166(57.7 to 75.0)
Serotype 4(n=357,350)
Title
Measurements
OG0001618(1453.2 to 1801.5)
OG0011491(1318.4 to 1685.8)
Serotype 5(n=350,353)
Title
Measurements
OG000267(224.7 to 317.0)
OG001312(266.2 to 366.6)
Serotype 6A(n=356,350)
Title
Measurements
OG0004266(3752.0 to 4849.9)
OG0013994(3442.0 to 4635.6)
Serotype 6B(n=354,351)
Title
Measurements
OG0003583(3130.7 to 4101.8)
OG0013567(3149.2 to 4040.9)
Serotype 7F(n=355,352)
Title
Measurements
OG0001636(1459.8 to 1834.3)
OG0011803(1624.6 to 2001.7)
Serotype 9V(n=353,347)
Title
Measurements
OG0001818(1581.5 to 2090.6)
OG0011551(1282.4 to 1875.8)
Serotype 14(n=355,350)
Title
Measurements
OG0001110(993.2 to 1239.7)
OG0011107(988.1 to 1240.1)
Serotype 18C(n=353,348)
Title
Measurements
OG0001800(1571.8 to 2060.7)
OG0011738(1485.4 to 2033.8)
Serotype 19A(n=354,352)
Title
Measurements
OG000913(815.7 to 1022.9)
OG001890(787.1 to 1006.5)
Serotype 19F(n=345,338)
Title
Measurements
OG0001202(1030.9 to 1402.0)
OG0011140(976.7 to 1330.3)
Serotype 23F(n=354,350)
Title
Measurements
OG0001837(1562.6 to 2159.9)
OG0011820(1552.0 to 2134.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.1
2-Sided
95
0.83
1.34
No
Superiority or Other
OG000
OG001
Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.9
2-Sided
95
0.75
1.08
No
Superiority or Other
OG000
OG001
Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.1
2-Sided
95
0.92
1.28
No
Superiority or Other
OG000
OG001
Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.9
2-Sided
95
0.68
1.08
No
Superiority or Other
OG000
OG001
Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.1
2-Sided
95
0.88
1.30
No
Superiority or Other
OG000
OG001
Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.0
2-Sided
95
0.84
1.21
No
Superiority or Other
OG000
OG001
Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.9
2-Sided
95
0.78
1.06
No
Superiority or Other
OG000
OG001
Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.2
2-Sided
95
0.93
1.48
No
Superiority or Other
OG000
OG001
Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.0
2-Sided
95
0.86
1.17
No
Superiority or Other
OG000
OG001
Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.0
2-Sided
95
0.84
1.27
No
Superiority or Other
OG000
OG001
Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.0
2-Sided
95
0.87
1.21
No
Superiority or Other
OG000
OG001
Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.1
2-Sided
95
0.85
1.31
No
Superiority or Other
OG000
OG001
Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.0
2-Sided
95
0.80
1.27
No
Superiority or Other
Units
Counts
Participants
OG000726
Title
Denominators
Categories
Serotype 1:Before 13vPnC (Year 5),(n=690)
Title
Measurements
OG00010(8.7 to 10.7)
Serotype 1: After 13vPnC (Year 5),(n=690)
Title
Measurements
OG000173(153.5 to 195.5)
Serotype 3: Before 13vPnC (Year 5),(n=699)
Title
Measurements
OG0008(7.6 to 9.2)
Serotype 3: After 13vPnC (Year 5),(n=699)
Title
Measurements
OG00062(56.6 to 68.0)
Serotype 4 : Before 13vPnC (Year 5),(n=667)
Title
Measurements
OG00088(73.5 to 106.6)
Serotype 4 : After 13vPnC (Year 5),(n=667)
Title
Measurements
OG0001553(1426.5 to 1691.4)
Serotype 5 : Before 13vPnC (Year 5),(n=694)
Title
Measurements
OG00016(13.8 to 18.0)
Serotype 5 :After 13vPnC (Year 5),(n=694)
Title
Measurements
OG000290(257.8 to 326.4)
Serotype 6A : Before 13vPnC (Year 5),(n=677)
Title
Measurements
OG000173(144.5 to 206.8)
Serotype 6A : After 13vPnC (Year 5),(n=677)
Title
Measurements
OG0004072(3684.3 to 4500.2)
Serotype 6B : Before 13vPnC (Year 5),(n=650)
Title
Measurements
OG000209(174.0 to 252.1)
Serotype 6B : After 13vPnC (Year 5),(n=650)
Title
Measurements
OG0003504(3181.3 to 3859.7)
Serotype 7F: Before 13vPnC (Year 5),(n=687)
Title
Measurements
OG000122(100.9 to 147.7)
Serotype 7F: After 13vPnC (Year 5),(n=687)
Title
Measurements
OG0001697(1569.0 to 1834.7)
Serotype 9V: Before 13vPnC (Year 5),(n=671)
Title
Measurements
OG00097(78.1 to 119.5)
Serotype 9V: After 13vPnC (Year 5),(n=671)
Title
Measurements
OG0001669(1479.9 to 1882.6)
Serotype 14: Before 13vPnC (Year 5),(n=678)
Title
Measurements
OG000289(250.5 to 332.9)
Serotype 14: After 13vPnC (Year 5),(n=678)
Title
Measurements
OG0001096(1011.1 to 1187.9)
Serotype 18C: Before 13vPnC (Year 5),(n=683)
Title
Measurements
OG000120(100.5 to 143.6)
Serotype 18C: After 13vPnC (Year 5),(n=683)
Title
Measurements
OG0001748(1573.5 to 1941.9)
Serotype 19A: Before 13vPnC (Year 5),(n=696)
Title
Measurements
OG000113(99.0 to 127.9)
Serotype 19A: After 13vPnC (Year 5),(n=696)
Title
Measurements
OG000900(827.1 to 978.4)
Serotype 19F: Before 13vPnC (Year 5),(n=649)
Title
Measurements
OG00038(31.5 to 45.1)
Serotype 19F: After 13vPnC (Year 5),(n=649)
Title
Measurements
OG0001146(1024.6 to 1282.9)
Serotype 23F: Before 13vPnC (Year 5),(n=685)
Title
Measurements
OG00050(42.2 to 59.0)
Serotype 23F: After 13vPnC (Year 5),(n=685)
Title
Measurements
OG0001819(1620.2 to 2043.0)
Units
Counts
Participants
OG000726
Title
Denominators
Categories
Serotype 1 (n=690)
Title
Measurements
OG00018.0(15.72 to 20.53)
Serotype 3(n=699)
Title
Measurements
OG0007.4(6.70 to 8.19)
Serotype 4(n=667)
Title
Measurements
OG00017.6(14.59 to 21.12)
Serotype 5 (n=694)
Title
Measurements
OG00018.4(16.12 to 20.99)
Serotype 6A(n=677)
Title
Measurements
OG00023.6(19.74 to 28.11)
Serotype 6B(n=650)
Title
Measurements
OG00016.7(13.98 to 20.02)
Serotype 7F(n=687)
Title
Measurements
OG00013.9(11.48 to 16.83)
Serotype 9V(n=671)
Title
Measurements
OG00017.3(14.10 to 21.17)
Serotype 14(n=678)
Title
Measurements
OG0003.8(3.32 to 4.34)
Serotype 18C(n=683)
Title
Measurements
OG00014.6(12.27 to 17.25)
Serotype 19A(n=696)
Title
Measurements
OG0008.0(7.07 to 9.04)
Serotype 19F(n=649)
Title
Measurements
OG00030.4(25.47 to 36.34)
Serotype 23F(n=685)
Title
Measurements
OG00036.5(30.84 to 43.12)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1:After 13vPnC (Year 0),(n=381)
Title
Measurements
OG000217(184.0 to 255.0)
Serotype 1: After 13vPnC (Year 5),(n=381)
Title
Measurements
OG000183(156.6 to 214.6)
Serotype 3: After 13vPnC (Year 0),(n=374)
Title
Measurements
OG00069(60.0 to 78.7)
Serotype 3: After 13vPnC (Year 5),(n=374)
Title
Measurements
OG00061(54.4 to 69.0)
Serotype 4 : After 13vPnC (Year 0),(n=382)
Title
Measurements
OG0001905(1666.7 to 2177.5)
Serotype 4 : After 13vPnC (Year 5),(n=382)
Title
Measurements
OG0001589(1426.0 to 1771.3)
Serotype 5 : After 13vPnC (Year 0),(n=374)
Title
Measurements
OG000129(104.5 to 160.1)
Serotype 5 :After 13vPnC (Year 5),(n=374)
Title
Measurements
OG000300(256.8 to 350.4)
Serotype 6A : After 13vPnC (Year 0),(n=390)
Title
Measurements
OG0002779(2345.5 to 3293.0)
Serotype 6A : After 13vPnC (Year 5),(n=390)
Title
Measurements
OG0004196(3677.1 to 4787.1)
Serotype 6B : After 13vPnC (Year 0),(n=380)
Title
Measurements
OG0003089(2662.6 to 3584.8)
Serotype 6B : After 13vPnC (Year 5),(n=380)
Title
Measurements
OG0003541(3158.7 to 3968.9)
Serotype 7F: After 13vPnC (Year 0),(n=372)
Title
Measurements
OG0002196(1839.7 to 2620.3)
Serotype 7F: After 13vPnC (Year 5),(n=372)
Title
Measurements
OG0001768(1596.9 to 1958.3)
Serotype 9V: After 13vPnC (Year 0),(n=387)
Title
Measurements
OG0001343(1097.1 to 1643.7)
Serotype 9V: After 13vPnC (Year 5),(n=387)
Title
Measurements
OG0001768(1501.6 to 2081.6)
Serotype 14: After 13vPnC (Year 0),(n=383)
Title
Measurements
OG0001169(994.7 to 1374.1)
Serotype 14: After 13vPnC (Year 5),(n=383)
Title
Measurements
OG0001135(1017.5 to 1265.1)
Serotype 18C: After 13vPnC (Year 0),(n=381)
Title
Measurements
OG0001728(1420.9 to 2101.1)
Serotype 18C: After 13vPnC (Year 5),(n=381)
Title
Measurements
OG0001772(1540.0 to 2038.3)
Serotype 19A: After 13vPnC (Year 0),(n=378)
Title
Measurements
OG000879(769.0 to 1005.4)
Serotype 19A: After 13vPnC (Year 5),(n=378)
Title
Measurements
OG000858(763.9 to 963.0)
Serotype 19F: After 13vPnC (Year 0),(n=369)
Title
Measurements
OG000472(383.9 to 579.9)
Serotype 19F: After 13vPnC (Year 5),(n=369)
Title
Measurements
OG0001139(982.7 to 1319.6)
Serotype 23F: After 13vPnC (Year 0),(n=368)
Title
Measurements
OG000494(396.4 to 615.2)
Serotype 23F: After 13vPnC (Year 5),(n=368)
Title
Measurements
OG0001955(1700.6 to 2246.7)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1 (n=381)
Title
Measurements
OG0000.8(0.70 to 1.02)
Serotype 3(n=374)
Title
Measurements
OG0000.9(0.79 to 1.01)
Serotype 4(n=382)
Title
Measurements
OG0000.8(0.73 to 0.95)
Serotype 5 (n=374)
Title
Measurements
OG0002.3(1.92 to 2.80)
Serotype 6A(n=390)
Title
Measurements
OG0001.5(1.31 to 1.74)
Serotype 6B(n=380)
Title
Measurements
OG0001.1(1.00 to 1.31)
Serotype 7F(n=372)
Title
Measurements
OG0000.8(0.67 to 0.96)
Serotype 9V(n=387)
Title
Measurements
OG0001.3(1.08 to 1.60)
Serotype 14(n=383)
Title
Measurements
OG0001.0(0.83 to 1.13)
Serotype 18C(n=381)
Title
Measurements
OG0001.0(0.86 to 1.22)
Serotype 19A(n=378)
Title
Measurements
OG0001.0(0.88 to 1.08)
Serotype 19F(n=369)
Title
Measurements
OG0002.4(2.01 to 2.90)
Serotype 23F(n=368)
Title
Measurements
OG0004.0(3.26 to 4.80)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1:Before 13vPnC (Year 0),(n=384)
Title
Measurements
OG0006(5.6 to 6.9)
Serotype 1: After 13vPnC (Year 5),(n=384)
Title
Measurements
OG000171(145.4 to 200.4)
Serotype 3: Before 13vPnC (Year 0),(n=380)
Title
Measurements
OG0006(5.6 to 6.9)
Serotype 3: After 13vPnC (Year 5),(n=380)
Title
Measurements
OG00060(53.0 to 67.8)
Serotype 4 : Before 13vPnC (Year 0),(n=310)
Title
Measurements
OG00022(16.3 to 28.9)
Serotype 4 : After 13vPnC (Year 5),(n=310)
Title
Measurements
OG0001558(1379.0 to 1761.0)
Serotype 5 : Before 13vPnC (Year 0),(n=370)
Title
Measurements
OG0005(4.6 to 5.4)
Serotype 5 :After 13vPnC (Year 5),(n=370)
Title
Measurements
OG000284(241.8 to 333.1)
Serotype 6A : Before 13vPnC (Year 0),(n=356)
Title
Measurements
OG00018(14.3 to 23.1)
Serotype 6A : After 13vPnC (Year 5),(n=356)
Title
Measurements
OG0004072(3533.5 to 4692.1)
Serotype 6B : Before 13vPnC (Year 0),(n=333)
Title
Measurements
OG00053(38.7 to 71.6)
Serotype 6B : After 13vPnC (Year 5),(n=333)
Title
Measurements
OG0003341(2930.6 to 3809.9)
Serotype 7F: Before 13vPnC (Year 0),(n=330)
Title
Measurements
OG00010(7.7 to 12.2)
Serotype 7F: After 13vPnC (Year 5),(n=330)
Title
Measurements
OG0001818(1624.0 to 2035.0)
Serotype 9V: Before 13vPnC (Year 0),(n=352)
Title
Measurements
OG00028(21.3 to 37.5)
Serotype 9V: After 13vPnC (Year 5),(n=352)
Title
Measurements
OG0001725(1451.1 to 2050.8)
Serotype 14: Before 13vPnC (Year 0),(n=369)
Title
Measurements
OG00067(50.8 to 87.2)
Serotype 14: After 13vPnC (Year 5),(n=369)
Title
Measurements
OG0001164(1041.9 to 1300.8)
Serotype 18C: Before 13vPnC (Year 0),(n=361)
Title
Measurements
OG00020(15.7 to 25.2)
Serotype 18C: After 13vPnC (Year 5),(n=361)
Title
Measurements
OG0001824(1579.7 to 2105.6)
Serotype 19A: Before 13vPnC (Year 0),(n=348)
Title
Measurements
OG00028(22.6 to 33.8)
Serotype 19A: After 13vPnC (Year 5),(n=348)
Title
Measurements
OG000849(749.6 to 961.0)
Serotype 19F: Before 13vPnC (Year 0),(n=377)
Title
Measurements
OG00014(11.3 to 16.7)
Serotype 19F: After 13vPnC (Year 5),(n=377)
Title
Measurements
OG0001106(954.7 to 1281.3)
Serotype 23F: Before 13vPnC (Year 0),(n=350)
Title
Measurements
OG0009(7.2 to 10.2)
Serotype 23F: After 13vPnC (Year 5),(n=350)
Title
Measurements
OG0001851(1590.3 to 2155.3)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1 (n=384)
Title
Measurements
OG00027.5(23.05 to 32.78)
Serotype 3(n=380)
Title
Measurements
OG0009.7(8.34 to 11.19)
Serotype 4(n=310)
Title
Measurements
OG00071.8(53.28 to 96.69)
Serotype 5 (n=370)
Title
Measurements
OG00057.0(48.03 to 67.58)
Serotype 6A(n=356)
Title
Measurements
OG000224.1(171.09 to 293.51)
Serotype 6B(n=333)
Title
Measurements
OG00063.5(46.14 to 87.45)
Serotype 7F(n=330)
Title
Measurements
OG000188.0(147.92 to 238.83)
Serotype 9V(n=352)
Title
Measurements
OG00061.0(45.19 to 82.31)
Serotype 14(n=369)
Title
Measurements
OG00017.5(13.40 to 22.86)
Serotype 18C(n=361)
Title
Measurements
OG00091.7(71.33 to 117.84)
Serotype 19A(n=348)
Title
Measurements
OG00030.7(24.99 to 37.77)
Serotype 19F(n=377)
Title
Measurements
OG00080.5(64.90 to 99.92)
Serotype 23F(n=350)
Title
Measurements
OG000216.5(172.97 to 270.87)
Units
Counts
Participants
OG000130
Title
Denominators
Categories
Serotype 1: Before 13vPnC dose Year 0 (n=92)
Title
Measurements
OG0006(4.9 to 7.0)
Serotype 1: After 13vPnC dose at Year 0 (n=92)
Title
Measurements
OG000200(143.5 to 278.0)
Serotype 1: Year 1 (n=125)
Title
Measurements
OG00019(14.0 to 26.7)
Serotype 1: Year 2 (n=128)
Title
Measurements
OG00014(10.1 to 18.2)
Serotype 1: Year 3 (n=128)
Title
Measurements
OG00011(8.3 to 14.5)
Serotype 1: Year 4 (n=127)
Title
Measurements
OG00010(7.4 to 12.4)
Serotype 1: Before 13vPnC dose Year 5 (n=126)
Title
Measurements
OG00010(7.8 to 12.8)
Serotype 1: After 13vPnC dose at Year 5 (n=126)
Title
Measurements
OG000203(158.5 to 260.6)
Serotype 3: Before 13vPnC dose Year 0 (n=90)
Title
Measurements
OG0006(4.9 to 7.3)
Serotype 3: After 13vPnC dose Year 0 (n=91)
Title
Measurements
OG00063(48.1 to 83.6)
Serotype 3: Year 1 (n=129)
Title
Measurements
OG00014(10.7 to 17.2)
Serotype 3: Year 2 (n=129)
Title
Measurements
OG00012(9.2 to 14.7)
Serotype 3: Year 3 (n=129)
Title
Measurements
OG0009(7.1 to 10.7)
Serotype 3: Year 4 (n=128)
Title
Measurements
OG0009(7.2 to 11.3)
Serotype 3: Before 13vPnC dose Year 5 (n=129)
Title
Measurements
OG0009(7.3 to 11.7)
Serotype 3: After 13vPnC dose at Year 5 (n=128)
Title
Measurements
OG00055(44.6 to 68.1)
Serotype 4: Before 13vPnC dose Year 0 (n=74)
Title
Measurements
OG00016(8.8 to 27.3)
Serotype 4: After 13vPnC dose at Year 0 (n=91)
Title
Measurements
OG0001896(1429.7 to 2514.2)
Serotype 4: Year 1 (n=126)
Title
Measurements
OG000442(309.0 to 632.4)
Serotype 4: Year 2 (n=121)
Title
Measurements
OG000181(117.1 to 278.7)
Serotype 4: Year 3 (n=125)
Title
Measurements
OG000137(89.4 to 211.0)
Serotype 4: Year 4 (n=123)
Title
Measurements
OG00097(62.2 to 151.5)
Serotype 4: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00092(59.7 to 140.6)
Serotype 4: After 13vPnC dose at Year 5 (n=128)
Title
Measurements
OG0001574(1340.7 to 1847.9)
Serotype 5: Before 13vPnC dose Year 0 (n=89)
Title
Measurements
OG0005(4.1 to 5.2)
Serotype 5: After 13vPnC dose at Year 0 (n=93)
Title
Measurements
OG000145(96.5 to 216.6)
Serotype 5: Year 1 (n=130)
Title
Measurements
OG00032(22.8 to 43.7)
Serotype 5: Year 2 (n=128)
Title
Measurements
OG00020(14.4 to 27.0)
Serotype 5: Year 3 (n=128)
Title
Measurements
OG00017(12.3 to 23.0)
Serotype 5: Year 4 (n=128)
Title
Measurements
OG00014(10.7 to 19.3)
Serotype 5: Before 13vPnC dose Year 5 (n=129)
Title
Measurements
OG00013(9.9 to 17.8)
Serotype 5: After 13vPnC dose at Year 5 (n=128)
Title
Measurements
OG000273(204.7 to 365.2)
Serotype 6A: Before 13vPnC dose Year 0 (n=87)
Title
Measurements
OG00016(9.9 to 26.1)
Serotype 6A: After 13vPnC dose Year 0 (n=94)
Title
Measurements
OG0002158(1456.8 to 3196.6)
Serotype 6A: Year 1 (n=126)
Title
Measurements
OG000748(532.4 to 1051.3)
Serotype 6A: Year 2 (n=129)
Title
Measurements
OG000405(275.0 to 595.8)
Serotype 6A: Year 3 (n=127)
Title
Measurements
OG000282(187.7 to 424.1)
Serotype 6A: Year 4 (n=126)
Title
Measurements
OG000203(134.6 to 306.1)
Serotype 6A: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG000166(107.5 to 255.3)
Serotype 6A: After 13vPnC dose Year 5 (n=129)
Title
Measurements
OG0003777(2916.3 to 4891.2)
Serotype 6B: Before 13vPnC dose Year 0 (n=83)
Title
Measurements
OG00088(46.7 to 165.8)
Serotype 6B: After 13vPnC dose Year 0 (n=93)
Title
Measurements
OG0002950(2110.7 to 4123.5)
Serotype 6B: Year 1 (n=122)
Title
Measurements
OG000765(562.2 to 1039.9)
Serotype 6B: Year 2 (n=121)
Title
Measurements
OG000505(353.9 to 720.2)
Serotype 6B: Year 3 (n=120)
Title
Measurements
OG000373(253.3 to 549.8)
Serotype 6B: Year 4 (n=115)
Title
Measurements
OG000326(218.2 to 485.9)
Serotype 6B: Before 13vPnC dose Year 5 (n=123)
Title
Measurements
OG000229(149.1 to 350.3)
Serotype 6B: After 13vPnC dose Year 5 (n=127)
Title
Measurements
OG0003804(3216.1 to 4499.0)
Serotype 7F: Before 13vPnC dose Year 0 (n=80)
Title
Measurements
OG00013(7.9 to 23.0)
Serotype 7F: After 13vPnC dose Year 0 (n=88)
Title
Measurements
OG0002265(1563.6 to 3280.4)
Serotype 7F: Year 1 (n=129)
Title
Measurements
OG000515(356.6 to 745.1)
Serotype 7F: Year 2 (n=128)
Title
Measurements
OG000279(182.4 to 426.9)
Serotype 7F: Year 3 (n=125)
Title
Measurements
OG000253(165.1 to 387.4)
Serotype 7F: Year 4 (n=127)
Title
Measurements
OG000175(114.3 to 268.6)
Serotype 7F: Before 13vPnC dose Year 5 (n=124)
Title
Measurements
OG000155(98.7 to 244.5)
Serotype 7F: After 13vPnC dose Year 5 (n=129)
Title
Measurements
OG0001932(1585.5 to 2353.7)
Serotype 9V: Before 13vPnC dose Year 0 (n=88)
Title
Measurements
OG00017(9.7 to 28.3)
Serotype 9V: After 13vPnC dose Year 0 (n=93)
Title
Measurements
OG0001202(795.7 to 1816.4)
Serotype 9V: Year 1 (n=125)
Title
Measurements
OG000276(173.2 to 440.3)
Serotype 9V: Year 2 (n=127)
Title
Measurements
OG000136(83.4 to 221.5)
Serotype 9V: Year 3 (n=128)
Title
Measurements
OG000121(75.2 to 194.7)
Serotype 9V: Year 4 (n=124)
Title
Measurements
OG00066(39.8 to 108.7)
Serotype 9V: Before 13vPnC dose Year 5 (n=128)
Title
Measurements
OG00086(53.1 to 139.9)
Serotype 9V: After 13vPnC dose Year 5 (n=127)
Title
Measurements
OG0001572(1155.4 to 2139.2)
Serotype 14: Before 13vPnC dose Year 0 (n=87)
Title
Measurements
OG00074(41.7 to 130.1)
Serotype 14: After 13vPnC dose Year 0 (n=90)
Title
Measurements
OG0001436(1036.7 to 1989.0)
Serotype 14: Year 1 (n=124)
Title
Measurements
OG000541(394.3 to 741.1)
Serotype 14: Year 2 (n=125)
Title
Measurements
OG000446(326.5 to 609.0)
Serotype 14: Year 3 (n=124)
Title
Measurements
OG000416(302.8 to 571.3)
Serotype 14: Year 4 (n=125)
Title
Measurements
OG000341(241.9 to 481.4)
Serotype 14: Before 13vPnC dose Year 5 (n=127)
Title
Measurements
OG000335(244.8 to 457.6)
Serotype 14: After 13vPnC dose Year 5 (n=128)
Title
Measurements
OG0001238(1046.4 to 1464.2)
Serotype 18C: Before 13vPnC dose Year 0 (n=82)
Title
Measurements
OG00018(11.4 to 29.2)
Serotype 18C: After 13vPnC dose Year 0 (n=92)
Title
Measurements
OG0001189(766.6 to 1843.2)
Serotype 18C: Year 1 (n=127)
Title
Measurements
OG000301(206.2 to 440.4)
Serotype 18C: Year 2 (n=123)
Title
Measurements
OG000170(115.2 to 251.6)
Serotype 18C: Year 3 (n=129)
Title
Measurements
OG000115(76.7 to 171.2)
Serotype 18C: Year 4 (n=126)
Title
Measurements
OG000102(67.6 to 154.9)
Serotype 18C: Before 13vPnC dose Year 5 (n=127)
Title
Measurements
OG00099(65.9 to 148.1)
Serotype 18C: After 13vPnC dose Year 5 (n=127)
Title
Measurements
OG0001580(1289.0 to 1937.4)
Serotype 19A: Before 13vPnC dose Year 0 (n=84)
Title
Measurements
OG00024(15.7 to 37.1)
Serotype 19A: After 13vPnC dose Year 0 (n=92)
Title
Measurements
OG000727(551.4 to 957.4)
Serotype 19A: Year 1 (n=130)
Title
Measurements
OG000193(145.9 to 255.4)
Serotype 19A: Year 2 (n=127)
Title
Measurements
OG000135(100.4 to 181.9)
Serotype 19A: Year 3 (n=129)
Title
Measurements
OG000105(76.6 to 143.3)
Serotype 19A: Year 4 (n=129)
Title
Measurements
OG00097(72.0 to 131.6)
Serotype 19A: Before 13vPnC dose Year 5 (n=130)
Title
Measurements
OG00097(71.7 to 132.3)
Serotype 19A: After 13vPnC dose Year 5 (n=128)
Title
Measurements
OG000874(729.8 to 1046.1)
Serotype 19F: Before 13vPnC dose Year 0 (n=94)
Title
Measurements
OG00014(9.3 to 21.1)
Serotype 19F: After 13vPnC dose Year 0 (n=91)
Title
Measurements
OG000448(298.8 to 670.5)
Serotype 19F: Year 1 (n=124)
Title
Measurements
OG00085(55.7 to 131.0)
Serotype 19F: Year 2 (n=128)
Title
Measurements
OG00044(28.9 to 67.3)
Serotype 19F: Year 3 (n=128)
Title
Measurements
OG00035(23.0 to 54.4)
Serotype 19F: Year 4 (n=125)
Title
Measurements
OG00029(19.2 to 44.0)
Serotype 19F: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00024(15.9 to 36.1)
Serotype 19F: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0001112(882.3 to 1400.5)
Serotype 23F: Before 13vPnC dose Year 0 (n=84)
Title
Measurements
OG0009(6.1 to 13.3)
Serotype 23F: After 13vPnC dose Year 0 (n=89)
Title
Measurements
OG000396(242.7 to 646.6)
Serotype 23F: Year 1 (n=127)
Title
Measurements
OG000116(78.9 to 171.6)
Serotype 23F: Year 2 (n=124)
Title
Measurements
OG00095(64.1 to 141.0)
Serotype 23F: Year 3 (n=128)
Title
Measurements
OG00060(40.4 to 88.0)
Serotype 23F: Year 4 (n=127)
Title
Measurements
OG00054(36.8 to 78.6)
Serotype 23F: Before 13vPnC dose Year 5 (n=127)
Title
Measurements
OG00048(33.0 to 71.1)
Serotype 23F: After 13vPnC dose Year 5 (n=128)
Title
Measurements
OG0001642(1263.2 to 2133.5)
Units
Counts
Participants
OG000130
Title
Denominators
Categories
Serotype 1:After 13vPnC dose at Year 0 (n=89)
Title
Measurements
OG00034.0(24.24 to 47.66)
Serotype 1: Year 1 (n= 90)
Title
Measurements
OG0003.5(2.45 to 5.00)
Serotype 1: Year 2 (n=91)
Title
Measurements
OG0002.4(1.72 to 3.26)
Serotype 1: Year 3 (n= 92)
Title
Measurements
OG0001.8(1.38 to 2.47)
Serotype 1: Year 4 (n= 90)
Title
Measurements
OG0001.6(1.24 to 2.09)
Serotype 1: Before 13vPnC dose Year 5 (n=89)
Title
Measurements
OG0001.7(1.26 to 2.16)
Serotype 1: After 13vPnC dose at Year 5 (n=89)
Title
Measurements
OG00039.3(28.69 to 53.81)
Serotype 3: After 13vPnC dose at Year 0 (n=87)
Title
Measurements
OG00010.4(7.65 to 14.23)
Serotype 3: Year 1 (n=89)
Title
Measurements
OG0002.0(1.59 to 2.58)
Serotype 3: Year 2 (n=89)
Title
Measurements
OG0001.6(1.29 to 2.01)
Serotype 3: Year 3 (n=89)
Title
Measurements
OG0001.3(1.04 to 1.56)
Serotype 3: Year 4 (n=89)
Title
Measurements
OG0001.4(1.15 to 1.76)
Serotype 3: Before 13vPnC dose Year 5 (n=90)
Title
Measurements
OG0001.5(1.14 to 1.86)
Serotype 3: After 13vPnC dose at Year 5 (n=89)
Title
Measurements
OG0009.1(6.93 to 12.07)
Serotype 4: After 13vPnC dose at Year 0 (n=72)
Title
Measurements
OG000118.9(65.63 to 215.39)
Serotype 4: Year 1 (n=74)
Title
Measurements
OG00021.3(11.90 to 38.06)
Serotype 4: Year 2 (n=71)
Title
Measurements
OG0008.3(4.66 to 14.95)
Serotype 4: Year 3 (n=70)
Title
Measurements
OG0006.5(3.75 to 11.15)
Serotype 4: Year 4 (n=71)
Title
Measurements
OG0004.6(2.73 to 7.63)
Serotype 4: Before 13vPnC dose Year 5 (n=71)
Title
Measurements
OG0004.7(2.80 to 7.74)
Serotype 4: After 13vPnC dose at Year 5 (n=73)
Title
Measurements
OG00098.7(54.38 to 179.10)
Serotype 5: After 13vPnC dose at Year 0 (n=87)
Title
Measurements
OG00029.5(19.21 to 45.45)
Serotype 5: Year 1 (n=89)
Title
Measurements
OG0006.1(4.18 to 8.91)
Serotype 5: Year 2 (n=88)
Title
Measurements
OG0003.7(2.57 to 5.40)
Serotype 5: Year 3 (n=88)
Title
Measurements
OG0002.9(2.05 to 4.19)
Serotype 5: Year 4 (n=88)
Title
Measurements
OG0002.6(1.84 to 3.59)
Serotype 5: Before 13vPnC dose Year 5 (n=88)
Title
Measurements
OG0002.3(1.67 to 3.29)
Serotype 5: After 13vPnC dose at Year 5 (n=87)
Title
Measurements
OG00060.6(42.73 to 86.06)
Serotype 6A: After 13vPnC dose Year 0 (n=86)
Title
Measurements
OG000126.8(69.14 to 232.51)
Serotype 6A: Year 1 (n=85)
Title
Measurements
OG00038.3(22.35 to 65.79)
Serotype 6A: Year 2 (n=87)
Title
Measurements
OG00021.9(12.98 to 36.99)
Serotype 6A: Year 3 (n=86)
Title
Measurements
OG00014.8(8.83 to 24.79)
Serotype 6A: Year 4 (n=85)
Title
Measurements
OG00011.7(7.00 to 19.62)
Serotype 6A: Before 13vPnC dose Year 5 (n=85)
Title
Measurements
OG0009.2(5.40 to 15.81)
Serotype 6A: After 13vPnC dose Year 5 (n=86)
Title
Measurements
OG000219.2(123.97 to 387.54)
Serotype 6B: After 13vPnC dose Year 0 (n=81)
Title
Measurements
OG00033.3(17.17 to 64.74)
Serotype 6B: Year 1 (n=78)
Title
Measurements
OG0008.9(4.88 to 16.21)
Serotype 6B: Year 2 (n=78)
Title
Measurements
OG0005.7(3.18 to 10.14)
Serotype 6B: Year 3 (n=77)
Title
Measurements
OG0004.3(2.33 to 7.98)
Serotype 6B: Year 4 (n=73)
Title
Measurements
OG0003.3(1.91 to 5.75)
Serotype 6B: Before 13vPnC dose Year 5 (n=81)
Title
Measurements
OG0002.9(1.63 to 5.28)
Serotype 6B: After 13vPnC dose Year 5 (n=81)
Title
Measurements
OG00038.8(19.92 to 75.61)
Serotype 7F: After 13vPnC dose Year 0 (n=75)
Title
Measurements
OG000168.6(88.78 to 320.29)
Serotype 7F: Year 1 (n=80)
Title
Measurements
OG00037.1(19.84 to 69.34)
Serotype 7F: Year 2 (n=78)
Title
Measurements
OG00018.7(10.16 to 34.57)
Serotype 7F: Year 3 (n=76)
Title
Measurements
OG00017.8(9.69 to 32.66)
Serotype 7F: Year 4 (n=78)
Title
Measurements
OG00010.4(5.69 to 18.93)
Serotype 7F: Before 13vPnC dose Year 5 (n=77)
Title
Measurements
OG0008.4(4.57 to 15.56)
Serotype 7F: After 13vPnC dose Year 5 (n=80)
Title
Measurements
OG000163.6(95.30 to 280.70)
Serotype 9V: After 13vPnC dose Year 0 (n=86)
Title
Measurements
OG00068.2(37.54 to 123.92)
Serotype 9V: Year 1 (n=86)
Title
Measurements
OG00012.2(6.94 to 21.55)
Serotype 9V: Year 2 (n=87)
Title
Measurements
OG0005.6(3.30 to 9.63)
Serotype 9V: Year 3 (n=88)
Title
Measurements
OG0005.3(3.20 to 8.80)
Serotype 9V: Year 4 (n=84)
Title
Measurements
OG0003.0(1.79 to 5.00)
Serotype 9V: Before 13vPnC dose Year 5 (n=87)
Title
Measurements
OG0003.8(2.19 to 6.66)
Serotype 9V: After 13vPnC dose Year 5 (n=86)
Title
Measurements
OG00099.3(54.99 to 179.41)
Serotype 14: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG00022.4(12.42 to 40.22)
Serotype 14: Year 1 (n=84)
Title
Measurements
OG0007.3(4.35 to 12.22)
Serotype 14: Year 2 (n=85)
Title
Measurements
OG0006.2(3.86 to 10.11)
Serotype 14: Year 3 (n=82)
Title
Measurements
OG0005.2(3.12 to 8.80)
Serotype 14: Year 4 (n=84)
Title
Measurements
OG0005.5(3.26 to 9.42)
Serotype 14: Before 13vPnC dose Year 5 (n=86)
Title
Measurements
OG0004.7(2.85 to 7.86)
Serotype 14: After 13vPnC dose Year 5 (n=86)
Title
Measurements
OG00019.9(11.37 to 35.00)
Serotype 18C: After 13vPnC dose Year 0 (n=79)
Title
Measurements
OG00058.2(31.53 to 107.35)
Serotype 18C: Year 1 (n=81)
Title
Measurements
OG00012.3(7.45 to 20.29)
Serotype 18C: Year 2 (n=81)
Title
Measurements
OG0006.2(3.73 to 10.34)
Serotype 18C: Year 3 (n=81)
Title
Measurements
OG0004.5(2.82 to 7.30)
Serotype 18C: Year 4 (n=79)
Title
Measurements
OG0003.9(2.46 to 6.22)
Serotype 18C: Before 13vPnC dose Year 5 (n=81)
Title
Measurements
OG0003.9(2.40 to 6.28)
Serotype 18C: After 13vPnC dose Year 5 (n=79)
Title
Measurements
OG00082.7(50.04 to 136.70)
Serotype 19A: After 13vPnC dose Year 0 (n=81)
Title
Measurements
OG00028.4(18.04 to 44.69)
Serotype 19A: Year 1 (n=84)
Title
Measurements
OG0007.3(4.72 to 11.16)
Serotype 19A: Year 2 (n=82)
Title
Measurements
OG0005.4(3.55 to 8.18)
Serotype 19A: Year 3 (n=84)
Title
Measurements
OG0004.1(2.72 to 6.10)
Serotype 19A: Year 4 (n=84)
Title
Measurements
OG0003.7(2.42 to 5.61)
Serotype 19A: Before 13vPnC dose Year 5 (n=84)
Title
Measurements
OG0003.8(2.45 to 5.99)
Serotype 19A: After 13vPnC dose Year 5 (n=83)
Title
Measurements
OG00036.4(23.40 to 56.57)
Serotype 19F: After 13vPnC dose Year 0 (n=90)
Title
Measurements
OG00032.8(20.67 to 51.98)
Serotype 19F: Year 1 (n=91)
Title
Measurements
OG0006.3(4.08 to 9.86)
Serotype 19F: Year 2 (n=93)
Title
Measurements
OG0003.9(2.58 to 6.02)
Serotype 19F: Year 3 (n=92)
Title
Measurements
OG0002.7(1.76 to 4.09)
Serotype 19F: Year 4 (n=91)
Title
Measurements
OG0002.4(1.62 to 3.56)
Serotype 19F: Before 13vPnC dose Year 5 (n=90)
Title
Measurements
OG0001.9(1.26 to 2.83)
Serotype 19F: After 13vPnC dose Year 5 (n=89)
Title
Measurements
OG00081.6(52.36 to 127.08)
Serotype 23F: After 13vPnC dose Year 0 (n=79)
Title
Measurements
OG00041.2(23.36 to 72.69)
Serotype 23F: Year 1 (n=84)
Title
Measurements
OG00012.6(7.69 to 20.62)
Serotype 23F: Year 2 (n=81)
Title
Measurements
OG0009.6(5.81 to 15.78)
Serotype 23F: Year 3 (n=84)
Title
Measurements
OG0006.6(4.13 to 10.41)
Serotype 23F: Year 4 (n=84)
Title
Measurements
OG0005.8(3.68 to 9.26)
Serotype 23F: Before 13vPnC dose Year 5 (n=83)
Title
Measurements
OG0005.3(3.31 to 8.53)
Serotype 23F: After 13vPnC dose Year 5 (n=82)
Title
Measurements
OG000194.0(115.99 to 324.32)
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000363
OG001363
Title
Denominators
Categories
Serotype 1 (n=357, 345)
Title
Measurements
OG0005.92(5.33 to 6.57)
OG0015.83(5.20 to 6.55)
Serotype 3(n=343, 338)
Title
Measurements
OG0000.69(0.62 to 0.76)
OG0010.72(0.65 to 0.80)
Serotype 4(n=357,345)
Title
Measurements
OG0004.90(4.42 to 5.44)
OG0014.77(4.22 to 5.39)
Serotype 5(n=357,345)
Title
Measurements
OG0007.49(6.71 to 8.35)
OG0018.02(7.16 to 8.99)
Serotype 6A(n=357,345)
Title
Measurements
OG00013.59(12.01 to 15.39)
OG00113.45(11.67 to 15.51)
Serotype 6B(n=355,345)
Title
Measurements
OG00020.18(17.74 to 22.96)
OG00121.76(18.97 to 24.96)
Serotype 7F(n=357,345)
Title
Measurements
OG0008.48(7.72 to 9.30)
OG0018.70(7.91 to 9.58)
Serotype 9V(n=357,345)
Title
Measurements
OG0005.91(5.37 to 6.51)
OG0016.35(5.74 to 7.02)
Serotype 14(n=357,345)
Title
Measurements
OG00015.57(13.94 to 17.39)
OG00116.39(14.70 to 18.28)
Serotype 18C(n=357,345)
Title
Measurements
OG0007.77(7.06 to 8.55)
OG0018.46(7.58 to 9.44)
Serotype 19A(n=357,345)
Title
Measurements
OG00016.77(15.09 to 18.64)
OG00117.97(16.14 to 20.01)
Serotype 19F(n=357,345)
Title
Measurements
OG00016.83(14.86 to 19.06)
OG00118.18(15.77 to 20.96)
Serotype 23F(n=357,345)
Title
Measurements
OG00018.15(15.87 to 20.76)
OG00120.25(17.57 to 23.32)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.01
2-Sided
95
0.87
1.18
No
Superiority or Other
OG000
OG001
Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.95
2-Sided
95
0.82
1.10
No
Superiority or Other
OG000
OG001
Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.03
2-Sided
95
0.88
1.21
No
Superiority or Other
OG000
OG001
Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.93
2-Sided
95
0.80
1.09
No
Superiority or Other
OG000
OG001
Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
1.01
2-Sided
95
0.84
1.22
No
Superiority or Other
OG000
OG001
Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.93
2-Sided
95
0.77
1.12
No
Superiority or Other
OG000
OG001
Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.97
2-Sided
95
0.85
1.11
No
Superiority or Other
OG000
OG001
Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.93
2-Sided
95
0.81
1.07
No
Superiority or Other
OG000
OG001
Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.95
2-Sided
95
0.81
1.11
No
Superiority or Other
OG000
OG001
Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.92
2-Sided
95
0.79
1.06
No
Superiority or Other
OG000
OG001
Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.93
2-Sided
95
0.80
1.08
No
Superiority or Other
OG000
OG001
Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.93
2-Sided
95
0.77
1.12
No
Superiority or Other
OG000
OG001
Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.
Geometric Mean Ratio
0.90
2-Sided
95
0.74
1.09
No
Superiority or Other
Units
Counts
Participants
OG000726
Title
Denominators
Categories
Serotype 1:Before 13vPnC (Year 5),(n=665)
Title
Measurements
OG0001.27(1.16 to 1.40)
Serotype 1: After 13vPnC (Year 5),(n=665)
Title
Measurements
OG0005.87(5.42 to 6.36)
Serotype 3: Before 13vPnC (Year 5),(n=623)
Title
Measurements
OG0000.33(0.30 to 0.37)
Serotype 3: After 13vPnC (Year 5),(n=623)
Title
Measurements
OG0000.71(0.65 to 0.76)
Serotype 4 : Before 13vPnC (Year 5),(n=663)
Title
Measurements
OG0000.67(0.60 to 0.74)
Serotype 4 : After 13vPnC (Year 5),(n=663)
Title
Measurements
OG0004.83(4.45 to 5.24)
Serotype 5 : Before 13vPnC (Year 5),(n=671)
Title
Measurements
OG0002.65(2.45 to 2.87)
Serotype 5 :After 13vPnC (Year 5),(n=671)
Title
Measurements
OG0007.76(7.16 to 8.41)
Serotype 6A : Before 13vPnC (Year 5),(n=671)
Title
Measurements
OG0002.52(2.33 to 2.73)
Serotype 6A : After 13vPnC (Year 5),(n=671)
Title
Measurements
OG00013.51(12.28 to 14.86)
Serotype 6B : Before 13vPnC (Year 5),(n=668)
Title
Measurements
OG0003.12(2.86 to 3.41)
Serotype 6B : After 13vPnC (Year 5),(n=668)
Title
Measurements
OG00021.04(19.12 to 23.16)
Serotype 7F: Before 13vPnC (Year 5),(n=671)
Title
Measurements
OG0002.52(2.31 to 2.76)
Serotype 7F: After 13vPnC (Year 5),(n=671)
Title
Measurements
OG0008.72(8.16 to 9.33)
Serotype 9V: Before 13vPnC (Year 5),(n=672)
Title
Measurements
OG0002.11(1.96 to 2.28)
Serotype 9V: After 13vPnC (Year 5),(n=672)
Title
Measurements
OG0006.14(5.71 to 6.59)
Serotype 14: Before 13vPnC (Year 5),(n=672)
Title
Measurements
OG0005.17(4.69 to 5.70)
Serotype 14: After 13vPnC (Year 5),(n=672)
Title
Measurements
OG00016.26(15.03 to 17.58)
Serotype 18C: Before 13vPnC (Year 5),(n=672)
Title
Measurements
OG0002.55(2.34 to 2.78)
Serotype 18C: After 13vPnC (Year 5),(n=672)
Title
Measurements
OG0008.10(7.52 to 8.72)
Serotype 19A: Before 13vPnC (Year 5),(n=671)
Title
Measurements
OG0005.47(5.07 to 5.89)
Serotype 19A: After 13vPnC (Year 5),(n=671)
Title
Measurements
OG00017.29(16.03 to 18.65)
Serotype 19F: Before 13vPnC (Year 5),(n=664)
Title
Measurements
OG0002.24(2.02 to 2.47)
Serotype 19F: After 13vPnC (Year 5),(n=664)
Title
Measurements
OG00017.73(16.10 to 19.53)
Serotype 23F: Before 13vPnC (Year 5),(n=671)
Title
Measurements
OG0002.50(2.29 to 2.73)
Serotype 23F: After 13vPnC (Year 5),(n=671)
Title
Measurements
OG00019.23(17.45 to 21.20)
Units
Counts
Participants
OG000726
Title
Denominators
Categories
Serotype 1 (n=665)
Title
Measurements
OG0004.62(4.22 to 5.05)
Serotype 3(n=623)
Title
Measurements
OG0002.11(1.99 to 2.24)
Serotype 4(n=663)
Title
Measurements
OG0007.24(6.60 to 7.95)
Serotype 5 (n=671)
Title
Measurements
OG0002.93(2.75 to 3.12)
Serotype 6A(n=671)
Title
Measurements
OG0005.35(4.92 to 5.82)
Serotype 6B(n=668)
Title
Measurements
OG0006.74(6.19 to 7.34)
Serotype 7F(n=671)
Title
Measurements
OG0003.46(3.20 to 3.74)
Serotype 9V(n=672)
Title
Measurements
OG0002.90(2.74 to 3.08)
Serotype 14(n=672)
Title
Measurements
OG0003.14(2.89 to 3.42)
Serotype 18C(n=672)
Title
Measurements
OG0003.18(2.96 to 3.41)
Serotype 19A(n=671)
Title
Measurements
OG0003.16(2.95 to 3.39)
Serotype 19F(n=664)
Title
Measurements
OG0007.93(7.21 to 8.72)
Serotype 23F(n=671)
Title
Measurements
OG0007.69(7.05 to 8.39)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1:After 13vPnC (Year 0),(n=389)
Title
Measurements
OG0004.77(4.10 to 5.54)
Serotype 1: After 13vPnC (Year 5),(n=389)
Title
Measurements
OG0005.88(5.32 to 6.50)
Serotype 3: After 13vPnC (Year 0),(n=378)
Title
Measurements
OG0001.26(1.13 to 1.40)
Serotype 3: After 13vPnC (Year 5),(n=378)
Title
Measurements
OG0000.74(0.67 to 0.81)
Serotype 4 : After 13vPnC (Year 0),(n=387)
Title
Measurements
OG0002.90(2.51 to 3.36)
Serotype 4 : After 13vPnC (Year 5),(n=387)
Title
Measurements
OG0005.13(4.64 to 5.68)
Serotype 5 : After 13vPnC (Year 0),(n=390)
Title
Measurements
OG0006.52(5.72 to 7.44)
Serotype 5 :After 13vPnC (Year 5),(n=390)
Title
Measurements
OG0008.25(7.40 to 9.20)
Serotype 6A : After 13vPnC (Year 0),(n=390)
Title
Measurements
OG0006.13(5.41 to 6.94)
Serotype 6A : After 13vPnC (Year 5),(n=390)
Title
Measurements
OG00013.52(11.94 to 15.31)
Serotype 6B : After 13vPnC (Year 0),(n=390)
Title
Measurements
OG0008.87(7.77 to 10.14)
Serotype 6B : After 13vPnC (Year 5),(n=390)
Title
Measurements
OG00020.70(18.31 to 23.39)
Serotype 7F: After 13vPnC (Year 0),(n=390)
Title
Measurements
OG0009.24(8.16 to 10.47)
Serotype 7F: After 13vPnC (Year 5),(n=390)
Title
Measurements
OG0008.40(7.68 to 9.19)
Serotype 9V: After 13vPnC (Year 0),(n=391)
Title
Measurements
OG0005.83(5.17 to 6.56)
Serotype 9V: After 13vPnC (Year 5),(n=391)
Title
Measurements
OG0006.07(5.53 to 6.65)
Serotype 14: After 13vPnC (Year 0),(n=391)
Title
Measurements
OG00011.98(10.33 to 13.91)
Serotype 14: After 13vPnC (Year 5),(n=391)
Title
Measurements
OG00015.04(13.57 to 16.66)
Serotype 18C: After 13vPnC (Year 0),(n=390)
Title
Measurements
OG00011.64(10.20 to 13.29)
Serotype 18C: After 13vPnC (Year 5),(n=390)
Title
Measurements
OG0008.25(7.47 to 9.12)
Serotype 19A: After 13vPnC (Year 0),(n=391)
Title
Measurements
OG00017.43(15.51 to 19.59)
Serotype 19A: After 13vPnC (Year 5),(n=391)
Title
Measurements
OG00018.48(16.68 to 20.48)
Serotype 19F: After 13vPnC (Year 0),(n=388)
Title
Measurements
OG0006.56(5.66 to 7.60)
Serotype 19F: After 13vPnC (Year 5),(n=388)
Title
Measurements
OG00018.26(16.14 to 20.66)
Serotype 23F: After 13vPnC (Year 0),(n=391)
Title
Measurements
OG0008.03(6.91 to 9.32)
Serotype 23F: After 13vPnC (Year 5),(n=391)
Title
Measurements
OG00020.17(17.81 to 22.83)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1 (n=389)
Title
Measurements
OG0001.23(1.07 to 1.42)
Serotype 3(n=378)
Title
Measurements
OG0000.59(0.54 to 0.64)
Serotype 4(n=387)
Title
Measurements
OG0001.77(1.56 to 2.01)
Serotype 5 (n=390)
Title
Measurements
OG0001.26(1.14 to 1.41)
Serotype 6A(n=390)
Title
Measurements
OG0002.21(1.97 to 2.47)
Serotype 6B(n=390)
Title
Measurements
OG0002.33(2.08 to 2.61)
Serotype 7F(n=390)
Title
Measurements
OG0000.91(0.81 to 1.02)
Serotype 9V(n=391)
Title
Measurements
OG0001.04(0.95 to 1.14)
Serotype 14(n=391)
Title
Measurements
OG0001.25(1.10 to 1.43)
Serotype 18C(n=390)
Title
Measurements
OG0000.71(0.64 to 0.79)
Serotype 19A(n=391)
Title
Measurements
OG0001.06(0.96 to 1.17)
Serotype 19F(n=388)
Title
Measurements
OG0002.78(2.44 to 3.17)
Serotype 23F(n=391)
Title
Measurements
OG0002.51(2.23 to 2.83)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1:Before 13vPnC (Year 0),(n=380)
Title
Measurements
OG0000.44(0.38 to 0.50)
Serotype 1: After 13vPnC (Year 5),(n=380)
Title
Measurements
OG0005.86(5.29 to 6.48)
Serotype 3: Before 13vPnC (Year 0),(n=368)
Title
Measurements
OG0000.47(0.42 to 0.53)
Serotype 3: After 13vPnC (Year 5),(n=368)
Title
Measurements
OG0000.74(0.67 to 0.81)
Serotype 4 : Before 13vPnC (Year 0),(n=373)
Title
Measurements
OG0000.22(0.19 to 0.26)
Serotype 4 : After 13vPnC (Year 5),(n=373)
Title
Measurements
OG0005.21(4.71 to 5.77)
Serotype 5 : Before 13vPnC (Year 0),(n=387)
Title
Measurements
OG0001.79(1.65 to 1.95)
Serotype 5 :After 13vPnC (Year 5),(n=387)
Title
Measurements
OG0008.32(7.46 to 9.27)
Serotype 6A : Before 13vPnC (Year 0),(n=386)
Title
Measurements
OG0001.56(1.42 to 1.71)
Serotype 6A : After 13vPnC (Year 5),(n=386)
Title
Measurements
OG00013.63(12.03 to 15.45)
Serotype 6B : Before 13vPnC (Year 0),(n=383)
Title
Measurements
OG0001.76(1.58 to 1.96)
Serotype 6B : After 13vPnC (Year 5),(n=383)
Title
Measurements
OG00021.09(18.66 to 23.84)
Serotype 7F: Before 13vPnC (Year 0),(n=384)
Title
Measurements
OG0000.70(0.62 to 0.79)
Serotype 7F: After 13vPnC (Year 5),(n=384)
Title
Measurements
OG0008.41(7.70 to 9.19)
Serotype 9V: Before 13vPnC (Year 0),(n=387)
Title
Measurements
OG0000.87(0.79 to 0.96)
Serotype 9V: After 13vPnC (Year 5),(n=387)
Title
Measurements
OG0006.07(5.53 to 6.66)
Serotype 14: Before 13vPnC (Year 0),(n=389)
Title
Measurements
OG0001.95(1.69 to 2.26)
Serotype 14: After 13vPnC (Year 5),(n=389)
Title
Measurements
OG00014.98(13.51 to 16.61)
Serotype 18C: Before 13vPnC (Year 0),(n=388)
Title
Measurements
OG0000.82(0.72 to 0.94)
Serotype 18C: After 13vPnC (Year 5),(n=388)
Title
Measurements
OG0008.24(7.45 to 9.11)
Serotype 19A: Before 13vPnC (Year 0),(n=388)
Title
Measurements
OG0002.92(2.66 to 3.22)
Serotype 19A: After 13vPnC (Year 5),(n=388)
Title
Measurements
OG00018.52(16.71 to 20.53)
Serotype 19F: Before 13vPnC (Year 0),(n=371)
Title
Measurements
OG0001.17(1.03 to 1.33)
Serotype 19F: After 13vPnC (Year 5),(n=371)
Title
Measurements
OG00018.68(16.46 to 21.19)
Serotype 23F: Before 13vPnC (Year 0),(n=382)
Title
Measurements
OG0000.97(0.86 to 1.09)
Serotype 23F: After 13vPnC (Year 5),(n=382)
Title
Measurements
OG00020.53(18.14 to 23.23)
Units
Counts
Participants
OG000598
Title
Denominators
Categories
Serotype 1 (n=380)
Title
Measurements
OG00013.37(11.66 to 15.33)
Serotype 3(n=368)
Title
Measurements
OG0001.57(1.43 to 1.73)
Serotype 4(n=373)
Title
Measurements
OG00023.59(20.21 to 27.55)
Serotype 5 (n=387)
Title
Measurements
OG0004.64(4.17 to 5.16)
Serotype 6A(n=386)
Title
Measurements
OG0008.74(7.63 to 10.00)
Serotype 6B(n=383)
Title
Measurements
OG00011.96(10.46 to 13.68)
Serotype 7F(n=384)
Title
Measurements
OG00011.96(10.53 to 13.57)
Serotype 9V(n=387)
Title
Measurements
OG0006.97(6.29 to 7.73)
Serotype 14(n=389)
Title
Measurements
OG0007.68(6.62 to 8.92)
Serotype 18C(n=388)
Title
Measurements
OG00010.04(8.84 to 11.40)
Serotype 19A(n=388)
Title
Measurements
OG0006.33(5.66 to 7.09)
Serotype 19F(n=371)
Title
Measurements
OG00015.95(13.69 to 18.57)
Serotype 23F(n=382)
Title
Measurements
OG00021.18(18.50 to 24.25)
Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000130
Title
Denominators
Categories
Serotype 1: Before 13vPnC dose Year 0 (n=79)
Title
Measurements
OG0000.37(0.28 to 0.49)
Serotype 1: After 13vPnC dose at Year 0 (n=83)
Title
Measurements
OG0004.53(3.33 to 6.18)
Serotype 1: Year 1 (n=119)
Title
Measurements
OG0001.96(1.55 to 2.48)
Serotype 1: Year 2 (n=124)
Title
Measurements
OG0001.56(1.25 to 1.96)
Serotype 1: Year 3 (n=126)
Title
Measurements
OG0001.34(1.08 to 1.66)
Serotype 1: Year 4 (n=125)
Title
Measurements
OG0001.32(1.06 to 1.63)
Serotype 1: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0001.18(0.95 to 1.47)
Serotype 1: After 13vPnC dose at Year 5 (n=125)
Title
Measurements
OG0006.08(5.20 to 7.11)
Serotype 3: Before 13vPnC dose Year 0 (n=81)
Title
Measurements
OG0000.42(0.33 to 0.53)
Serotype 3: After 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0001.15(0.92 to 1.44)
Serotype 3: Year 1 (n=115)
Title
Measurements
OG0000.37(0.30 to 0.46)
Serotype 3: Year 2 (n=122)
Title
Measurements
OG0000.34(0.27 to 0.42)
Serotype 3: Year 3 (n=119)
Title
Measurements
OG0000.30(0.25 to 0.37)
Serotype 3: Year 4 (n=117)
Title
Measurements
OG0000.31(0.25 to 0.38)
Serotype 3: Before 13vPnC dose Year 5 (n=117)
Title
Measurements
OG0000.30(0.24 to 0.38)
Serotype 3: After 13vPnC dose at Year 5 (n=121)
Title
Measurements
OG0000.66(0.55 to 0.79)
Serotype 4: Before 13vPnC dose Year 0 (n=80)
Title
Measurements
OG0000.19(0.14 to 0.25)
Serotype 4: After 13vPnC dose at Year 0 (n=82)
Title
Measurements
OG0002.41(1.74 to 3.35)
Serotype 4: Year 1 (n=118)
Title
Measurements
OG0000.98(0.77 to 1.26)
Serotype 4: Year 2 (n=123)
Title
Measurements
OG0000.77(0.61 to 0.98)
Serotype 4: Year 3 (n=125)
Title
Measurements
OG0000.67(0.53 to 0.85)
Serotype 4: Year 4 (n=125)
Title
Measurements
OG0000.64(0.50 to 0.82)
Serotype 4: Before 13vPnC dose Year 5 (n=122)
Title
Measurements
OG0000.58(0.46 to 0.74)
Serotype 4: After 13vPnC dose at Year 5 (n=125)
Title
Measurements
OG0004.62(3.92 to 5.45)
Serotype 5: Before 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0001.40(1.17 to 1.69)
Serotype 5: After 13vPnC dose at Year 0 (n=83)
Title
Measurements
OG0005.80(4.40 to 7.64)
Serotype 5: Year 1 (n=118)
Title
Measurements
OG0003.10(2.58 to 3.73)
Serotype 5: Year 2 (n=124)
Title
Measurements
OG0002.62(2.19 to 3.14)
Serotype 5: Year 3 (n=126)
Title
Measurements
OG0002.40(2.01 to 2.86)
Serotype 5: Year 4 (n=125)
Title
Measurements
OG0002.44(2.05 to 2.91)
Serotype 5: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0002.41(2.01 to 2.88)
Serotype 5: After 13vPnC dose at Year 5 (n=125)
Title
Measurements
OG0007.14(5.95 to 8.57)
Serotype 6A: Before 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0001.34(1.09 to 1.66)
Serotype 6A: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0005.74(4.29 to 7.68)
Serotype 6A: Year 1 (n=119)
Title
Measurements
OG0003.64(2.95 to 4.50)
Serotype 6A: Year 2 (n=124)
Title
Measurements
OG0003.10(2.54 to 3.79)
Serotype 6A: Year 3 (n=126)
Title
Measurements
OG0002.76(2.26 to 3.38)
Serotype 6A: Year 4 (n=126)
Title
Measurements
OG0002.74(2.26 to 3.32)
Serotype 6A: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0002.63(2.16 to 3.21)
Serotype 6A: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00014.31(11.43 to 17.93)
Serotype 6B: Before 13vPnC dose Year 0 (n=81)
Title
Measurements
OG0001.56(1.23 to 1.97)
Serotype 6B: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0008.24(6.17 to 11.00)
Serotype 6B: Year 1 (n=119)
Title
Measurements
OG0004.96(3.97 to 6.20)
Serotype 6B: Year 2 (n=124)
Title
Measurements
OG0003.97(3.23 to 4.88)
Serotype 6B: Year 3 (n=126)
Title
Measurements
OG0003.58(2.91 to 4.41)
Serotype 6B: Year 4 (n=126)
Title
Measurements
OG0003.53(2.88 to 4.31)
Serotype 6B: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0003.18(2.56 to 3.93)
Serotype 6B: After 13vPnC dose Year 5 (n=124)
Title
Measurements
OG00021.61(17.55 to 26.60)
Serotype 7F: Before 13vPnC dose Year 0 (n=81)
Title
Measurements
OG0000.64(0.51 to 0.81)
Serotype 7F: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0009.14(6.78 to 12.31)
Serotype 7F: Year 1 (n=119)
Title
Measurements
OG0003.82(3.05 to 4.79)
Serotype 7F: Year 2 (n=124)
Title
Measurements
OG0003.10(2.46 to 3.89)
Serotype 7F: Year 3 (n=126)
Title
Measurements
OG0002.58(2.08 to 3.19)
Serotype 7F: Year 4 (n=126)
Title
Measurements
OG0002.55(2.05 to 3.18)
Serotype 7F: Before 13vPnC dose Year 5 (n=124)
Title
Measurements
OG0002.36(1.90 to 2.93)
Serotype 7F: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0008.05(6.68 to 9.71)
Serotype 9V: Before 13vPnC dose Year 0 (n=80)
Title
Measurements
OG0000.77(0.63 to 0.95)
Serotype 9V: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0004.58(3.62 to 5.81)
Serotype 9V: Year 1 (n=119)
Title
Measurements
OG0002.84(2.39 to 3.37)
Serotype 9V: Year 2 (n=124)
Title
Measurements
OG0002.37(1.99 to 2.81)
Serotype 9V: Year 3 (n=126)
Title
Measurements
OG0002.16(1.82 to 2.56)
Serotype 9V: Year 4 (n=126)
Title
Measurements
OG0002.09(1.76 to 2.47)
Serotype 9V: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0001.97(1.67 to 2.34)
Serotype 9V: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0005.99(5.14 to 6.98)
Serotype 14: Before 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0002.21(1.64 to 2.97)
Serotype 14: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG00014.48(10.72 to 19.57)
Serotype 14: Year 1 (n=119)
Title
Measurements
OG0007.71(6.07 to 9.80)
Serotype 14: Year 2 (n=124)
Title
Measurements
OG0006.82(5.47 to 8.49)
Serotype 14: Year 3 (n=126)
Title
Measurements
OG0005.71(4.50 to 7.25)
Serotype 14: Year 4 (n=126)
Title
Measurements
OG0005.31(4.22 to 6.69)
Serotype 14: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0005.30(4.20 to 6.70)
Serotype 14: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00016.85(14.07 to 20.18)
Serotype 18C: Before 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0000.81(0.62 to 1.07)
Serotype 18C: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0008.11(6.03 to 10.89)
Serotype 18C: Year 1 (n=119)
Title
Measurements
OG0003.45(2.85 to 4.18)
Serotype 18C: Year 2 (n=124)
Title
Measurements
OG0002.82(2.35 to 3.38)
Serotype 18C: Year 3 (n=126)
Title
Measurements
OG0002.38(1.98 to 2.86)
Serotype 18C: Year 4 (n=126)
Title
Measurements
OG0002.44(2.07 to 2.88)
Serotype 18C: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0002.26(1.89 to 2.71)
Serotype 18C: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0006.94(5.92 to 8.12)
Serotype 19A: Before 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0002.57(2.13 to 3.11)
Serotype 19A: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG00014.11(11.28 to 17.64)
Serotype 19A: Year 1 (n=119)
Title
Measurements
OG0006.95(5.78 to 8.35)
Serotype 19A: Year 2 (n=124)
Title
Measurements
OG0006.13(5.19 to 7.25)
Serotype 19A: Year 3 (n=126)
Title
Measurements
OG0005.60(4.73 to 6.63)
Serotype 19A: Year 4 (n=126)
Title
Measurements
OG0005.47(4.65 to 6.45)
Serotype 19A: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0005.11(4.32 to 6.05)
Serotype 19A: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00015.77(13.25 to 18.78)
Serotype 19F: Before 13vPnC dose Year 0 (n=78)
Title
Measurements
OG0000.99(0.75 to 1.29)
Serotype 19F: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0005.64(4.16 to 7.66)
Serotype 19F: Year 1 (n=118)
Title
Measurements
OG0002.87(2.29 to 3.60)
Serotype 19F: Year 2 (n=121)
Title
Measurements
OG0002.55(2.05 to 3.16)
Serotype 19F: Year 3 (n=124)
Title
Measurements
OG0002.28(1.84 to 2.83)
Serotype 19F: Year 4 (n=125)
Title
Measurements
OG0002.26(1.83 to 2.81)
Serotype 19F: Before 13vPnC dose Year 5 (n=123)
Title
Measurements
OG0002.10(1.66 to 2.66)
Serotype 19F: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00017.37(14.23 to 21.20)
Serotype 23F: Before 13vPnC dose Year 0 (n=80)
Title
Measurements
OG0000.97(0.73 to 1.30)
Serotype 23F: After 13vPnC dose Year 0 (n=83)
Title
Measurements
OG0006.06(4.38 to 8.39)
Serotype 23F: Year 1 (n=118)
Title
Measurements
OG0003.65(2.96 to 4.51)
Serotype 23F: Year 2 (n=123)
Title
Measurements
OG0002.93(2.40 to 3.57)
Serotype 23F: Year 3 (n=126)
Title
Measurements
OG0002.67(2.19 to 3.25)
Serotype 23F: Year 4 (n=126)
Title
Measurements
OG0002.62(2.16 to 3.17)
Serotype 23F: Before 13vPnC dose Year 5 (n=125)
Title
Measurements
OG0002.50(2.05 to 3.04)
Serotype 23F: After 13vPnC dose Year 5 (n=125)
Title
Measurements
OG00016.95(13.73 to 20.91)
Units
Counts
Participants
OG000130
Title
Denominators
Categories
Serotype 1:After 13vPnC dose at Year 0 (n=79)
Title
Measurements
OG00012.50(9.25 to 16.90)
Serotype 1: Year 1 (n=72)
Title
Measurements
OG0005.64(4.32 to 7.35)
Serotype 1: Year 2 (n=75)
Title
Measurements
OG0004.73(3.73 to 6.00)
Serotype 1: Year 3 (n=76)
Title
Measurements
OG0004.01(3.15 to 5.11)
Serotype 1: Year 4 (n=75)
Title
Measurements
OG0003.79(3.00 to 4.78)
Serotype 1: Before 13vPnC dose Year 5 (n=76)
Title
Measurements
OG0003.41(2.72 to 4.28)
Serotype 1: After 13vPnC dose at Year 5 (n=77)
Title
Measurements
OG00015.25(11.63 to 19.99)
Serotype 3: After 13vPnC dose at Year 0 (n=80)
Title
Measurements
OG0002.69(2.21 to 3.28)
Serotype 3: Year 1 (n=73)
Title
Measurements
OG0000.89(0.74 to 1.07)
Serotype 3: Year 2 (n=77)
Title
Measurements
OG0000.77(0.66 to 0.90)
Serotype 3: Year 3 (n= 77)
Title
Measurements
OG0000.72(0.62 to 0.84)
Serotype 3: Year 4 (n=72)
Title
Measurements
OG0000.69(0.58 to 0.82)
Serotype 3: Before 13vPnC dose Year 5 (n=74)
Title
Measurements
OG0000.65(0.56 to 0.76)
Serotype 3: After 13vPnC dose at Year 5 (n=78)
Title
Measurements
OG0001.51(1.22 to 1.87)
Serotype 4: After 13vPnC dose at Year 0 (n=79)
Title
Measurements
OG00012.81(9.27 to 17.70)
Serotype 4: Year 1 (n=74)
Title
Measurements
OG0006.00(4.52 to 7.96)
Serotype 4: Year 2 (n=75)
Title
Measurements
OG0004.63(3.51 to 6.10)
Serotype 4: Year 3 (n=77)
Title
Measurements
OG0004.12(3.11 to 5.46)
Serotype 4: Year 4 (n=76)
Title
Measurements
OG0003.82(2.90 to 5.03)
Serotype 4: Before 13vPnC dose Year 5 (n=77)
Title
Measurements
OG0003.41(2.61 to 4.46)
Serotype 4: After 13vPnC dose at Year 5 (n=78)
Title
Measurements
OG00024.99(18.07 to 34.56)
Serotype 5: After 13vPnC dose at Year 0 (n=82)
Title
Measurements
OG0004.21(3.27 to 5.43)
Serotype 5: Year 1 (n=75)
Title
Measurements
OG0002.43(2.02 to 2.92)
Serotype 5: Year 2 (n=78)
Title
Measurements
OG0002.05(1.74 to 2.42)
Serotype 5: Year 3 (n=79)
Title
Measurements
OG0001.86(1.58 to 2.18)
Serotype 5: Year 4 (n=78)
Title
Measurements
OG0001.84(1.58 to 2.16)
Serotype 5: Before 13vPnC dose Year 5 (n=79)
Title
Measurements
OG0001.74(1.47 to 2.08)
Serotype 5: After 13vPnC dose at Year 5 (n=80)
Title
Measurements
OG0005.38(4.26 to 6.80)
Serotype 6A: After 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0004.32(3.35 to 5.57)
Serotype 6A: Year 1 (n=75)
Title
Measurements
OG0002.66(2.15 to 3.27)
Serotype 6A: Year 2 (n=78)
Title
Measurements
OG0002.15(1.80 to 2.57)
Serotype 6A: Year 3 (n=79)
Title
Measurements
OG0001.96(1.64 to 2.34)
Serotype 6A: Year 4 (n=78)
Title
Measurements
OG0001.91(1.62 to 2.26)
Serotype 6A: Before 13vPnC dose Year 5 (n=79)
Title
Measurements
OG0001.74(1.46 to 2.07)
Serotype 6A: After 13vPnC dose Year 5 (n=80)
Title
Measurements
OG00010.18(7.50 to 13.82)
Serotype 6B: After 13vPnC dose Year 0 (n=81)
Title
Measurements
OG0005.50(4.09 to 7.39)
Serotype 6B: Year 1 (n=74)
Title
Measurements
OG0003.24(2.53 to 4.15)
Serotype 6B: Year 2 (n=77)
Title
Measurements
OG0002.59(2.13 to 3.16)
Serotype 6B: Year 3 (n=78)
Title
Measurements
OG0002.36(1.94 to 2.88)
Serotype 6B: Year 4 (n=77)
Title
Measurements
OG0002.20(1.83 to 2.65)
Serotype 6B: Before 13vPnC dose Year 5 (n=78)
Title
Measurements
OG0001.92(1.57 to 2.36)
Serotype 6B: After 13vPnC dose Year 5 (n=79)
Title
Measurements
OG00012.82(9.51 to 17.26)
Serotype 7F: After 13vPnC dose Year 0 (n=81)
Title
Measurements
OG00014.60(10.96 to 19.46)
Serotype 7F: Year 1 (n=75)
Title
Measurements
OG0006.28(4.91 to 8.03)
Serotype 7F: Year 2 (n=77)
Title
Measurements
OG0005.03(3.97 to 6.39)
Serotype 7F: Year 3 (n=78)
Title
Measurements
OG0004.12(3.30 to 5.15)
Serotype 7F: Year 4 (n=77)
Title
Measurements
OG0003.87(3.11 to 4.80)
Serotype 7F: Before 13vPnC dose Year 5 (n=77)
Title
Measurements
OG0003.63(2.92 to 4.50)
Serotype 7F: After 13vPnC dose Year 5 (n=79)
Title
Measurements
OG00011.65(8.85 to 15.33)
Serotype 9V: After 13vPnC dose Year 0 (n=80)
Title
Measurements
OG0005.81(4.68 to 7.22)
Serotype 9V: Year 1 (n=75)
Title
Measurements
OG0003.34(2.80 to 3.98)
Serotype 9V: Year 2 (n=77)
Title
Measurements
OG0002.90(2.44 to 3.45)
Serotype 9V: Year 3 (n=77)
Title
Measurements
OG0002.60(2.20 to 3.09)
Serotype 9V: Year 4 (n=76)
Title
Measurements
OG0002.51(2.14 to 2.94)
Serotype 9V: Before 13vPnC dose Year 5 (n=77)
Title
Measurements
OG0002.24(1.89 to 2.65)
Serotype 9V: After 13vPnC dose Year 5 (n=78)
Title
Measurements
OG0007.35(5.92 to 9.12)
Serotype 14: After 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0006.47(4.43 to 9.46)
Serotype 14: Year 1 (n=75)
Title
Measurements
OG0004.00(2.86 to 5.59)
Serotype 14: Year 2 (n=78)
Title
Measurements
OG0003.54(2.61 to 4.82)
Serotype 14: Year 3 (n=79)
Title
Measurements
OG0003.10(2.28 to 4.22)
Serotype 14: Year 4 (n=78)
Title
Measurements
OG0002.84(2.10 to 3.83)
Serotype 14: Before 13vPnC dose Year 5 (n=79)
Title
Measurements
OG0002.68(1.96 to 3.67)
Serotype 14: After 13vPnC dose Year 5 (n=80)
Title
Measurements
OG0006.94(5.11 to 9.42)
Serotype 18C: After 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0009.86(7.35 to 13.23)
Serotype 18C: Year 1 (n=75)
Title
Measurements
OG0004.56(3.54 to 5.87)
Serotype 18C: Year 2 (n=78)
Title
Measurements
OG0003.74(2.95 to 4.74)
Serotype 18C: Year 3 (n=79)
Title
Measurements
OG0003.11(2.42 to 4.01)
Serotype 18C: Year 4 (n=78)
Title
Measurements
OG0002.97(2.38 to 3.71)
Serotype 18C: Before 13vPnC dose Year 5 (n=79)
Title
Measurements
OG0002.77(2.21 to 3.46)
Serotype 18C: After 13vPnC dose Year 5 (n=80)
Title
Measurements
OG0008.73(6.64 to 11.48)
Serotype 19A: After 13vPnC dose Year 0 (n=82)
Title
Measurements
OG0005.52(4.44 to 6.87)
Serotype 19A: Year 1 (n=75)
Title
Measurements
OG0002.69(2.21 to 3.28)
Serotype 19A: Year 2 (n=78)
Title
Measurements
OG0002.39(2.00 to 2.85)
Serotype 19A: Year 3 (n=79)
Title
Measurements
OG0002.14(1.80 to 2.54)
Serotype 19A: Year 4 (n=78)
Title
Measurements
OG0002.06(1.75 to 2.42)
Serotype 19A: Before 13vPnC dose Year 5 (n=79)
Title
Measurements
OG0001.87(1.59 to 2.21)
Serotype 19A: After 13vPnC dose Year 5 (n=80)
Title
Measurements
OG0006.00(4.78 to 7.52)
Serotype 19F: After 13vPnC dose Year 0 (n=78)
Title
Measurements
OG0006.02(4.68 to 7.75)
Serotype 19F: Year 1 (n=71)
Title
Measurements
OG0003.39(2.66 to 4.32)
Serotype 19F: Year 2 (n=72)
Title
Measurements
OG0002.74(2.22 to 3.39)
Serotype 19F: Year 3 (n=76)
Title
Measurements
OG0002.42(1.97 to 2.98)
Serotype 19F: Year 4 (n=75)
Title
Measurements
OG0002.24(1.85 to 2.72)
Serotype 19F: Before 13vPnC dose Year 5 (n=74)
Title
Measurements
OG0002.01(1.59 to 2.55)
Serotype 19F: After 13vPnC dose Year 5 (n=76)
Title
Measurements
OG00018.16(13.04 to 25.30)
Serotype 23F: After 13vPnC dose Year 0 (n=80)
Title
Measurements
OG0006.65(5.03 to 8.78)
Serotype 23F: Year 1 (n=73)
Title
Measurements
OG0003.57(2.90 to 4.40)
Serotype 23F: Year 2 (n=75)
Title
Measurements
OG0003.09(2.53 to 3.78)
Serotype 23F: Year 3 (n=77)
Title
Measurements
OG0002.93(2.35 to 3.65)
Serotype 23F: Year 4 (n=76)
Title
Measurements
OG0002.77(2.23 to 3.46)
Serotype 23F: Before 13vPnC dose Year 5 (n=77)
Title
Measurements
OG0002.48(2.01 to 3.07)
Serotype 23F: After 13vPnC dose Year 5 (n=78)
Title
Measurements
OG00016.52(12.29 to 22.22)
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000551
OG001560
Title
Denominators
Categories
Redness: Any (n=282,263)
Title
Measurements
OG00016.3
OG0013.0
Redness: Mild (n=281,262)
Title
Measurements
OG00015.7
OG0012.7
Redness: Moderate (n=265,258)
Title
Measurements
OG0004.2
OG0010.4
Redness: Severe (n=262,257)
Title
Measurements
OG0000.4
OG0010.0
Swelling: Any (n=288,263)
Title
Measurements
OG00018.4
OG0013.0
Swelling: Mild (n=288,263)
Title
Measurements
OG00017.0
OG0013.0
Swelling: Moderate (n=263,257)
Title
Measurements
OG0005.7
OG0010.0
Swelling: Severe (262,257)
Title
Measurements
OG0000.4
OG0010.0
Pain: Any (n=469,321)
Title
Measurements
OG00086.8
OG00137.1
Pain: Mild (n=459, 318)
Title
Measurements
OG00082.8
OG00135.2
Pain: Moderate (n=324,261)
Title
Measurements
OG00039.2
OG0014.2
Pain: Severe (n=267,258)
Title
Measurements
OG0004.1
OG0010.4
Limitation of arm movement:Any(317,270)
Title
Measurements
OG00035.6
OG0018.9
Limitation of arm movement:Mild(n=310,268)
Title
Measurements
OG00032.6
OG0018.2
Limitation of arm movement: Moderate(n=269,259)
Title
Measurements
OG0005.2
OG0011.2
Limitation of arm movement:Severe(n=266,258)
Title
Measurements
OG0003.4
OG0010.8
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000551
OG001560
Title
Denominators
Categories
Redness: Any (n=238,257)
Title
Measurements
OG0001.7
OG00112.1
Redness: Mild (n=238,255)
Title
Measurements
OG0001.7
OG00110.2
Redness: Moderate (n=236,248)
Title
Measurements
OG0000.0
OG0015.6
Redness: Severe (n=236,242)
Title
Measurements
OG0000.0
OG0011.2
Swelling: Any (n=242,265)
Title
Measurements
OG0004.5
OG00114.7
Swelling: Mild (n=242,260)
Title
Measurements
OG0004.5
OG00112.3
Swelling: Moderate (n=236,249)
Title
Measurements
OG0000.4
OG0016.4
Swelling: Severe (236,241)
Title
Measurements
OG0000.0
OG0010.4
Pain: Any (n=294,453)
Title
Measurements
OG00032.0
OG00184.5
Pain: Mild (n=290, 431)
Title
Measurements
OG00030.7
OG00182.1
Pain: Moderate (n=243,319)
Title
Measurements
OG0004.5
OG00141.1
Pain: Severe (n=236,248)
Title
Measurements
OG0000.0
OG0014.8
Limitation of arm movement:Any(248,318)
Title
Measurements
OG0009.3
OG00142.5
Limitation of arm movement:Mild(n=248,316)
Title
Measurements
OG0009.3
OG00141.1
Limitation of arm movement: Moderate(n=236,248)
Title
Measurements
OG0000.4
OG0015.2
Limitation of arm movement:Severe(n=236,244)
Title
Measurements
OG0000.0
OG0012.9
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000364
OG001363
Title
Denominators
Categories
Redness: Any (n=216,215)
Title
Measurements
OG00015.7
OG00120.9
Redness: Mild (n=215,212)
Title
Measurements
OG00014.0
OG00117.5
Redness: Moderate (n=210,211)
Title
Measurements
OG0007.1
OG00112.3
Redness: Severe (n=205,202)
Title
Measurements
OG0001.5
OG0010.5
Swelling: Any (n=224,216)
Title
Measurements
OG00018.8
OG00118.1
Swelling: Mild (n=223,214)
Title
Measurements
OG00017.5
OG00115.9
Swelling: Moderate (n=211,208)
Title
Measurements
OG0007.1
OG0019.6
Swelling: Severe (205,203)
Title
Measurements
OG0000.0
OG0011.0
Pain: Any (n=313,306)
Title
Measurements
OG00079.2
OG00179.4
Pain: Mild (n=297, 299)
Title
Measurements
OG00076.4
OG00174.9
Pain: Moderate (n=248,235)
Title
Measurements
OG00032.7
OG00134.9
Pain: Severe (n=206,205)
Title
Measurements
OG0004.4
OG0013.4
Limitation of arm movement:Any(233,224)
Title
Measurements
OG00023.2
OG00126.3
Limitation of arm movement:Mild(n=233,219)
Title
Measurements
OG00022.3
OG00122.8
Limitation of arm movement: Moderate(n=208,206)
Title
Measurements
OG0002.9
OG0013.9
Limitation of arm movement:Severe(n=206,206)
Title
Measurements
OG0001.9
OG0013.4
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000551
OG001560
Title
Denominators
Categories
Fever: >=38 but <38.5 degree C(n=261,259)
Title
Measurements
OG0001.5
OG0011.2
Fever: >=38.5 but <39 degree C(n=262,257)
Title
Measurements
OG0001.5
OG0010.0
Fever: >=39 but =<40.0 degree C(n=261,257)
Title
Measurements
OG0000.4
OG0010.0
Fever:>40.0 degree C (n=261,257)
Title
Measurements
OG0000.0
OG0010.4
Fatigue(n=389,359)
Title
Measurements
OG00058.1
OG00152.4
Headache(n=399,382)
Title
Measurements
OG00065.9
OG00156.5
Chills(n=306,291)
Title
Measurements
OG00031.4
OG00121.0
Rash(n=278,264)
Title
Measurements
OG00012.6
OG0014.9
Vomiting(n=266,262)
Title
Measurements
OG0005.3
OG0013.4
Decreased appetite(n=315,301)
Title
Measurements
OG00030.2
OG00122.6
New generalized muscle pain(n=385,326)
Title
Measurements
OG00065.5
OG00137.7
Aggravated generalized muscle pain(n=314,294)
Title
Measurements
OG00034.7
OG00124.1
New generalized joint pain(n=309,296)
Title
Measurements
OG00033.0
OG00124.7
Aggravated generalized joint pain(n=292,284)
Title
Measurements
OG00021.2
OG00118.0
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000551
OG001560
Title
Denominators
Categories
Fever: >=38 but <38.5 degree C(n=238,241)
Title
Measurements
OG0001.3
OG0011.2
Fever: >=38.5 but <39 degree C(n=239,240)
Title
Measurements
OG0001.3
OG0010.8
Fever: >=39 but =<40 degree (n=236,240)
Title
Measurements
OG0000.4
OG0010.4
Fever: >40.0 degree C(n=237,240)
Title
Measurements
OG0000.4
OG0010.0
Fatigue (n=316,338)
Title
Measurements
OG00043.7
OG00151.8
Headache (n=334,338)
Title
Measurements
OG00048.2
OG00150.9
Chills (n=273,276)
Title
Measurements
OG00020.5
OG00124.6
Rash (n=246,252)
Title
Measurements
OG0006.1
OG0019.5
Vomiting (n=247,247)
Title
Measurements
OG0006.9
OG0016.1
Decreased appetite(n=270,279)
Title
Measurements
OG00020.4
OG00125.8
New generalized muscle pain(n=288,350)
Title
Measurements
OG00028.5
OG00159.1
Aggravated generalized muscle pain(n=268,305)
Title
Measurements
OG00018.7
OG00136.7
New generalized joint pain(n=268,285)
Title
Measurements
OG00020.5
OG00127.4
Aggravated generalized joint pain(n=264,282)
Title
Measurements
OG00015.5
OG00123.8
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000364
OG001363
Title
Denominators
Categories
Fever: >= 38.0 degrees C (n=206,209)
Title
Measurements
OG0002.4
OG0015.3
Fever: >=38 but <38.5 degree C(n=205,206)
Title
Measurements
OG0001.0
OG0012.4
Fever: >=38.5 but <39 degree C(n=206,204)
Title
Measurements
OG0000.5
OG0012.0
Fever: >=39 but =<40 degree C(n=205,202)
Title
Measurements
OG0000.0
OG0010.0
Fever: >40 degree C(n=205,204)
Title
Measurements
OG0001.0
OG0011.5
Fatigue(n=263,251)
Title
Measurements
OG00043.7
OG00145.8
Headache(n=256,248)
Title
Measurements
OG00046.9
OG00151.2
Chills(n=229,217)
Title
Measurements
OG00023.1
OG00122.1
Rash(n=209,210)
Title
Measurements
OG0007.7
OG00113.8
Vomiting(n=206,207)
Title
Measurements
OG0003.4
OG0017.2
Decreased appetite(n=226,227)
Title
Measurements
OG00020.4
OG00122.0
New generalized muscle pain(n=266,253)
Title
Measurements
OG00047.7
OG00151.0
Aggravated generalized muscle pain(n=241,223)
Title
Measurements
OG00029.9
OG00127.4
New generalized joint pain(n=219,219)
Title
Measurements
OG00019.2
OG00121.9
Aggravated generalized joint pain(n=218,214)
Title
Measurements
OG00017.4
OG00118.2
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000551
OG001560
Title
Denominators
Categories
Acute pain (Dose 1):Mild
Title
Measurements
OG0006.7
OG0016.3
Acute pain (Dose 1):Moderate
Title
Measurements
OG0000.0
OG0010.0
Acute pain (Dose 1):Severe
Title
Measurements
OG0000.0
OG0010.0
Acute pain (Dose 1): Any
Title
Measurements
OG0006.7
OG0016.3
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000538
OG001543
Title
Denominators
Categories
Acute pain (Dose 2):Mild
Title
Measurements
OG0005.9
OG0016.4
Acute pain (Dose 2):Moderate
Title
Measurements
OG0000.0
OG0010.0
Acute pain (Dose 2):Severe
Title
Measurements
OG0000.0
OG0010.0
Acute pain (Dose 2):Any
Title
Measurements
OG0005.9
OG0016.4
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
Units
Counts
Participants
OG000364
OG001363
Title
Denominators
Categories
Acute pain at injection site:Mild
Title
Measurements
OG0003.8
OG0014.4
Acute pain at injection site:Moderate
Title
Measurements
OG0000.3
OG0010.0
Acute pain at injection site:Severe
Title
Measurements
OG0000.0
OG0010.0
Acute pain at injection site: Any
Title
Measurements
OG0004.1
OG0014.4
OG001
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)
Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.