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| ID | Type | Description | Link |
|---|---|---|---|
| V114-003 | Other Identifier | Merck Protocol Number |
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This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 Aluminum-adjuvanted | Experimental | Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
|
| V114 Non-adjuvanted | Experimental | Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
|
| Prevnar 13® | Active Comparator | Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 Aluminum-adjuvanted | Biological | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence [Pn ECL] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay [WHO ELISA] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | One month postvaccination 3 |
| IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | One month postvaccination 3 |
| IgG GMCs for Postvaccination 4 | The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | One month postvaccination 4 |
| Number of Participants With an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30244873 | Derived | Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, Stek JE, Abeygunawardana C, Winters MA, MacNair JE, Pujar NS, Musey L. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21. |
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There were 1152 participants randomized into the study. The 1142 participants included in this study excluded 4 subjects who each received a combination of vaccines and who each had a final disposition of completed and excludes an additional 6 subjects who were randomized but never vaccinated.
This trial was conducted in 58 trial centers: 4 in Canada, 8 in Finland, 3 in Israel, 1 in Puerto Rico, 3 in Spain and 39 in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 Adjuvanted | Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| FG001 | V114 Nonadjuvanted | Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| FG002 | PREVNAR 13® | Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V114 Adjuvanted | Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| BG001 | V114 Nonadjuvanted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence [Pn ECL] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay [WHO ELISA] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month postvaccination 3 |
|
Up to 1 month after final vaccination
The safety population consisted of all randomized participants who received study vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V114 | Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| V114 Non-adjuvanted | Biological | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose. |
|
| Prevnar 13® | Biological | 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose. |
|
| Up to Day 14 postvaccination |
| Number of Participants With an Injection-site AE | Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed. | Up to Day 14 postvaccination |
| Number of Participants With a Systemic AE | Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed. | Up to Day 14 postvaccination |
| Number of Participants With a Serious Adverse Event (SAE) | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. | Up to one month after last dose of study vaccine |
| Number of Participants Who Discontinued the Study Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. | Up to Day 14 postvaccination |
| One month postvaccination 3 |
| Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | One month postvaccination 4 |
| OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | One month postvaccination 3 |
| OPA GMTs as Measured by MOPA4 for Postvaccination 4 | The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | One month postvaccination 4 |
| Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | One month postvaccination 4 |
| Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | One month postvaccination 4 |
| Physician Decision |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
| BG002 | PREVNAR 13® | Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age. |
| BG003 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
| OG001 | V114 Nonadjuvanted | Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. |
| OG002 | PREVNAR 13® | Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age. |
|
|
| Primary | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month postvaccination 3 |
|
|
|
| Primary | IgG GMCs for Postvaccination 4 | The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month postvaccination 4 |
|
|
|
| Primary | Number of Participants With an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. | The analysis population included all randomized participants who received at least one dose of study vaccination. | Posted | Count of Participants | Participants | Up to Day 14 postvaccination |
|
|
|
| Primary | Number of Participants With an Injection-site AE | Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed. | The analysis population included all randomized participants who received at least one dose of study vaccination. | Posted | Count of Participants | Participants | Up to Day 14 postvaccination |
|
|
|
| Primary | Number of Participants With a Systemic AE | Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed. | Posted | Count of Participants | Participants | Up to Day 14 postvaccination |
|
|
|
| Primary | Number of Participants With a Serious Adverse Event (SAE) | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. | The analysis population included all randomized participants who received at least one dose of study vaccination. | Posted | Count of Participants | Participants | Up to one month after last dose of study vaccine |
|
|
|
| Primary | Number of Participants Who Discontinued the Study Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. | The analysis population included all randomized participants who received at least one dose of study vaccination. | Posted | Count of Participants | Participants | Up to Day 14 postvaccination |
|
|
|
| Secondary | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month postvaccination 3 |
|
|
|
| Secondary | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month postvaccination 4 |
|
|
|
| Secondary | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | One month postvaccination 3 |
|
|
|
| Secondary | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | One month postvaccination 4 |
|
|
|
| Secondary | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month postvaccination 4 |
|
|
|
| Secondary | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. | The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month postvaccination 4 |
|
|
|
| 1 |
| 368 |
| 25 |
| 368 |
| 345 |
| 368 |
| EG001 | V114 Non-Adjuvanted | Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. | 1 | 382 | 27 | 382 | 348 | 382 |
| EG002 | Prevnar | Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age. | 2 | 376 | 29 | 376 | 347 | 376 |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Developmental delay | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Gastritis viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Petit mal epilepsy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Breath holding | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 22F (non-PREVNAR 13® serotype) |
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| Serotype 23F |
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| Serotype 33F (non-PREVNAR 13® serotype) |
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| Serotype 3 |
|
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| Serotype 4 |
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| Serotype 5 |
|
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| Serotype 6A |
|
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| Serotype 6B |
|
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| Serotype 7F |
|
|
| Serotype 9V |
|
|
| Serotype 14 |
|
|
| Serotype 18C |
|
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| Serotype 19A |
|
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| Serotype 19F |
|
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| Serotype 22F (non-PREVNAR 13® serotype) |
|
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| Serotype 23F |
|
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| Serotype 33F (non-PREVNAR 13® serotype) |
|
|
| Serotype 3 |
|
|
| Serotype 4 |
|
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| Serotype 5 |
|
|
| Serotype 6A |
|
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| Serotype 6B |
|
|
| Serotype 7F |
|
|
| Serotype 9V |
|
|
| Serotype 14 |
|
|
| Serotype 18C |
|
|
| Serotype 19A |
|
|
| Serotype 19F |
|
|
| Serotype 22F (non-PREVNAR 13® serotype) |
|
|
| Serotype 23F |
|
|
| Serotype 33F (non-PREVNAR 13® serotype) |
|
|
|
| Serotype 4 |
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| Serotype 5 |
|
| Serotype 6A |
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| Serotype 6B |
|
| Serotype 7F |
|
| Serotype 9V |
|
| Serotype 14 |
|
| Serotype 18C |
|
| Serotype 19A |
|
| Serotype 19F |
|
| Serotype 22F (non-PREVNAR 13® serotype) |
|
| Serotype 23F |
|
| Serotype 33F (non-PREVNAR 13® serotype) |
|
| Serotype 3 |
|
|
| Serotype 4 |
|
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| Serotype 5 |
|
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| Serotype 6A |
|
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| Serotype 6B |
|
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| Serotype 7F |
|
|
| Serotype 9V |
|
|
| Serotype 14 |
|
|
| Serotype 18C |
|
|
| Serotype 19A |
|
|
| Serotype 19F |
|
|
| Serotype 22F (non-PREVNAR 13® serotype) |
|
|
| Serotype 23F |
|
|
| Serotype 33F (non-PREVNAR 13® serotype) |
|
|
|
| Serotype 4 |
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| Serotype 5 |
|
| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
|
| Serotype 9V |
|
| Serotype 14 |
|
| Serotype 18C |
|
| Serotype 19A |
|
| Serotype 19F |
|
| Serotype 22F (non-PREVNAR 13® serotype) |
|
| Serotype 23F |
|
| Serotype 33F (non-PREVNAR 13® serotype) |
|
| Serotype 3 |
|
|
| Serotype 4 |
|
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| Serotype 5 |
|
|
| Serotype 6A |
|
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| Serotype 6B |
|
|
| Serotype 7F |
|
|
| Serotype 9V |
|
|
| Serotype 14 |
|
|
| Serotype 18C |
|
|
| Serotype 19A |
|
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| Serotype 19F |
|
|
| Serotype 22F (non-PREVNAR 13® serotype) |
|
|
| Serotype 23F |
|
|
| Serotype 33F (non-PREVNAR 13® serotype) |
|
|
| Serotype 3 |
|
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 22F (non-PREVNAR 13® serotype) |
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| Serotype 23F |
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| Serotype 33F (non-PREVNAR 13® serotype) |
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