A Study to Evaluate the Safety, Tolerability and Immunoge... | NCT02531373 | Trialant
NCT02531373
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 2, 2019Actual
Enrollment
338Actual
Phase
Phase 1Phase 2
Conditions
Pneumococcal Infections
Interventions
V114 Medium Dose
V114 High Dose
V114 Medium Dose with Alternative Carrier Protein
V114 High Dose with Alternative Carrier Protein
Prevnar 13â„¢
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02531373
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V114-005
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
Official Title
A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2019
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 15, 2015Actual
Primary Completion Date
Apr 14, 2017Actual
Completion Date
Apr 14, 2017Actual
First Submitted Date
Aug 20, 2015
First Submission Date that Met QC Criteria
Aug 20, 2015
First Posted Date
Aug 24, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 16, 2018
Results First Submitted that Met QC Criteria
Mar 16, 2018
Results First Posted Date
Apr 17, 2018Actual
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
Mar 21, 2019
Last Update Posted Date
Apr 2, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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 designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.
Detailed Description
Not provided
Conditions Module
Conditions
Pneumococcal Infections
Keywords
Not provided
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
338Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adult: V114 Medium Dose
Experimental
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
Biological: V114 Medium Dose
Adult: V114 High Dose
Experimental
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
Biological: V114 High Dose
Adult: V114 Medium Dose with Alternative Carrier Protein
Experimental
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
Biological: V114 Medium Dose with Alternative Carrier Protein
Adult: V114 High Dose with Alternative Carrier Protein
Experimental
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
Biological: V114 High Dose with Alternative Carrier Protein
Infant: V114 Medium Dose
Experimental
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
V114 Medium Dose
Biological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Adults: Percentage of Participants With an Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to 6 weeks after vaccination
Infants: Percentage of Participants With an Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to 1 month after Vaccination 4 (Month 11-15)
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to time of Vaccination 4 (Month 10-13)
Secondary Outcomes
Measure
Description
Time Frame
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
1 month after vaccination
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adult Cohort: 18 to 49 years and in good health
Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
Infant Cohort: approximately 2 months (42 to 90 days) and in good health.
Exclusion Criteria:
Adult cohort: Prior administration of any pneumococcal vaccine
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
FG001
Adults: V114 High Dose
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 29, 2015
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel 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
ParticipantCare ProviderInvestigator
Biological: V114 Medium Dose
Infant: V114 High Dose
Experimental
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
Biological: V114 High Dose
Infant: V114 Medium Dose with Alternative Carrier Protein
Experimental
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
Biological: V114 Medium Dose with Alternative Carrier Protein
Infant: V114 High Dose with Alternative Carrier Protein
Experimental
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
Biological: V114 High Dose with Alternative Carrier Protein
Infant: Prevnar 13â„¢
Active Comparator
Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12 to 15 months of age.
Biological: Prevnar 13â„¢
Adult: V114 Medium Dose
Infant: V114 Medium Dose
V114 High Dose
Biological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
Adult: V114 High Dose
Infant: V114 High Dose
V114 Medium Dose with Alternative Carrier Protein
Biological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
Adult: V114 Medium Dose with Alternative Carrier Protein
Infant: V114 Medium Dose with Alternative Carrier Protein
V114 High Dose with Alternative Carrier Protein
Biological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
Adult: V114 High Dose with Alternative Carrier Protein
Infant: V114 High Dose with Alternative Carrier Protein
Prevnar 13â„¢
Biological
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Infant: Prevnar 13â„¢
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
Up to 14 days after any vaccination
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Up to 14 days after any vaccination
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
1 month after Vaccination 3 (Month 5)
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
Baseline and 1 month after vaccination
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
1 month after Vaccination 3 (Month 5)
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Before Vaccination 4 (Month 10-13)
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
1 month after Vaccination 4 (Month 11-15)
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Before Vaccination 4 (Month 10-13)
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
1 month after Vaccination 4 (Month 11-15)
FG002
Adults: V114 Medium Dose + ACP
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
FG003
Adults: V114 High Dose + ACP
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
FG004
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
FG005
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
FG006
Infants: V114 Medium Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
FG007
Infants: V114 High Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
FG008
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
FG00020 subjects
FG00120 subjects
FG00220 subjects
FG00320 subjects
FG00451 subjects
FG00551 subjects
FG00652 subjects
FG00752 subjects
FG00852 subjects
Vaccination 1
FG00020 subjects
FG00120 subjects
FG00220 subjects
FG00320 subjects
FG00450 subjects
FG00550 subjects
FG00652 subjects
FG00752 subjects
FG00852 subjects
Vaccination 2
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00449 subjects
FG00548 subjects
FG00650 subjects
FG00751 subjects
FG00851 subjects
Vaccination 3
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00448 subjects
FG00547 subjects
FG00649 subjects
FG00751 subjects
FG00849 subjects
Vaccination 4
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00444 subjects
FG00543 subjects
FG00643 subjects
FG00743 subjects
FG00843 subjects
COMPLETED
FG00020 subjects
FG00120 subjects
FG00220 subjects
FG00320 subjects
FG00443 subjects
FG00542 subjects
FG00641 subjects
FG00743 subjects
FG00843 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
FG0059 subjects
FG00611 subjects
FG0079 subjects
FG0089 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0052 subjects
FG0064 subjects
FG0078 subjects
FG0085 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Parent/Guardian
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All participants who received at least one study vaccination
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Adults: V114 Medium Dose
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
BG001
Adults: V114 High Dose
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
BG002
Adults: V114 Medium Dose + ACP
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
BG003
Adults: V114 High Dose + ACP
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
BG004
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
BG005
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
BG006
Infants: V114 Medium Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
BG007
Infants: V114 High Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
BG008
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00120
BG00220
BG00320
BG00450
BG00550
BG00652
BG00752
BG00852
BG009336
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
6 weeks
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00114
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Adults: Percentage of Participants With an Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
The analysis population included all randomized adult participants who received study vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 6 weeks after vaccination
ID
Title
Description
OG000
Adults: V114 Medium Dose
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
OG001
Adults: V114 High Dose
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
OG002
Adults: V114 Medium Dose + ACP
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
OG003
Adults: V114 High Dose + ACP
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG00090.0(68.3 to 98.8)
OG00195.0(75.1 to 99.9)
OG00295.0(75.1 to 99.9)
OG003
Primary
Infants: Percentage of Participants With an Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Posted
Number
Percentage of participants
Up to 1 month after Vaccination 4 (Month 11-15)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Primary
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Posted
Number
Percentage of participants
Up to time of Vaccination 4 (Month 10-13)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
Primary
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Posted
Number
Percentage of participants
Up to 14 days after any vaccination
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: V114 Medium Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
OG003
Primary
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
The analysis population included all randomized infant participants who received at least one dose of study vaccination and had follow-up for the outcome measure. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
Posted
Number
Percentage of participants
Up to 14 days after any vaccination
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: V114 Medium Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
OG003
Primary
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Geometric Mean
95% Confidence Interval
µg/mL
1 month after Vaccination 3 (Month 5)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Secondary
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Geometric Mean
95% Confidence Interval
µg/mL
1 month after vaccination
ID
Title
Description
OG000
Adults: V114 Medium Dose
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
OG001
Adults: V114 High Dose
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
Units
Counts
Participants
OG000
Secondary
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Baseline and 1 month after vaccination
ID
Title
Description
OG000
Adults: V114 Medium Dose
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
OG001
Adults: V114 High Dose
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
Units
Counts
Participants
Secondary
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after Vaccination 3 (Month 5)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Secondary
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Number
95% Confidence Interval
Percentage of participants
Before Vaccination 4 (Month 10-13)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Secondary
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after Vaccination 4 (Month 11-15)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Secondary
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Geometric Mean
95% Confidence Interval
µg/mL
Before Vaccination 4 (Month 10-13)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Secondary
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
Posted
Geometric Mean
95% Confidence Interval
µg/mL
1 month after Vaccination 4 (Month 11-15)
ID
Title
Description
OG000
Infants: V114 Medium Dose
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
OG001
Infants: V114 High Dose
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
OG002
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Time Frame
Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4.
Description
The analysis population included all randomized participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
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
V114 Medium Adults
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1
0
20
0
20
18
20
EG001
V114 High Adults
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1
0
20
0
20
19
20
EG002
V114 Medium + ACP Adults
Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1
0
20
0
20
19
20
EG003
V114 High + ACP Adults
Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1
0
20
0
20
18
20
EG004
V114 Medium Infants
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age
0
50
5
50
47
50
EG005
V114 High Infants
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age
0
50
4
50
46
50
EG006
V114 Medium + ACP Infants
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
0
51
1
51
49
51
EG007
V114 High + ACP Infants
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
0
52
3
52
51
52
EG008
Prevnar 13 Infants
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
0
52
4
52
51
52
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected20 at risk
EG0040 events0 affected50 at risk
EG0050 events0 affected50 at risk
EG0060 events0 affected51 at risk
EG0071 events1 affected52 at risk
EG0080 events0 affected52 at risk
Bronchiolitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Burns third degree
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Child maltreatment syndrome
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Neonatal insufficient breast milk syndrome
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG0030 events0 affected20 at risk
EG0045 events5 affected50 at risk
EG0054 events3 affected50 at risk
EG0064 events4 affected51 at risk
EG0072 events1 affected52 at risk
EG0086 events6 affected52 at risk
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0008 events7 affected20 at risk
EG0019 events9 affected20 at risk
EG0029 events9 affected20 at risk
EG003
Injection site bruising
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Injection site erythema
General disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0015 events5 affected20 at risk
EG0022 events2 affected20 at risk
EG003
Injection site induration
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Injection site pain
General disorders
MedDRA 20.0
Systematic Assessment
EG00020 events17 affected20 at risk
EG00123 events19 affected20 at risk
EG00224 events18 affected20 at risk
EG003
Injection site swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG0005 events5 affected20 at risk
EG0016 events6 affected20 at risk
EG0024 events4 affected20 at risk
EG003
Injection site warmth
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected20 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0008 events8 affected20 at risk
EG00110 events10 affected20 at risk
EG0027 events7 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected20 at risk
EG0014 events4 affected20 at risk
EG0025 events5 affected20 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected20 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 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
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
OG003
Infants: V114 High Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
OG004
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Units
Counts
Participants
OG00050
OG00150
OG00251
OG00352
OG00452
Title
Denominators
Categories
Title
Measurements
OG00096.0
OG00194.0
OG00296.1
OG00398.1
OG004100.0
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
OG004
Risk Difference (RD)
-4.0
2-Sided
95
-13.5
3.1
Equivalence
Miettinen and Nurminen method
OG001
OG004
Risk Difference (RD)
-6.0
2-Sided
95
-16.3
1.2
Equivalence
Miettinen and Nurminen method
OG002
OG004
Risk Difference (RD)
-3.9
2-Sided
95
-13.3
3.2
Equivalence
Miettinen and Nurminen method
OG003
OG004
Risk Difference (RD)
-1.9
2-Sided
95
-10.2
5.1
Equivalence
Miettinen and Nurminen method
OG002
Infants: V114 Medium Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age
OG003
Infants: V114 High Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
OG004
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Units
Counts
Participants
OG00050
OG00150
OG00251
OG00352
OG00452
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
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
OG004
Risk Difference (RD)
0.0
2-Sided
95
-6.9
7.2
Equivalence
Miettinen and Nurminen method
OG001
OG004
Risk Difference (RD)
0.0
2-Sided
95
-6.9
7.2
Equivalence
Miettinen and Nurminen method
OG002
OG004
Risk Difference (RD)
0.0
2-Sided
95
-6.9
7.1
Equivalence
Miettinen and Nurminen method
OG003
OG004
Risk Difference (RD)
0.0
2-Sided
95
-6.9
6.9
Equivalence
Miettinen and Nurminen method
Infants: V114 High Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
OG004
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age
Units
Counts
Participants
OG00050
OG00150
OG00251
OG00352
OG00452
Title
Denominators
Categories
Title
Measurements
OG00078.0
OG00180.0
OG00258.8
OG00380.8
OG00457.7
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
OG004
Miettinen and Nurminen method
0.029
Risk Difference (RD)
20.3
2-Sided
95
2.1
37.3
Equivalence
Miettinen and Nurminen method
OG001
OG004
Miettinen and Nurminen method
0.016
Risk Difference (RD)
22.3
2-Sided
95
4.3
39.1
Equivalence
Miettinen and Nurminen method
OG002
OG004
Miettinen and Nurminen method
0.908
Risk Difference (RD)
1.1
2-Sided
95
-17.7
19.9
Equivalence
Miettinen and Nurminen method
OG003
OG004
Miettinen and Nurminen method
0.011
Risk Difference (RD)
23.1
2-Sided
95
5.4
39.6
Equivalence
Miettinen and Nurminen method
Infants: V114 High Dose + ACP
Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age
OG004
Infants: Prevnar 13â„¢
Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age