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| ID | Type | Description | Link |
|---|---|---|---|
| B1851012 | Other Identifier | Alias Study Number | |
| 2008-006194-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Other | All subjects will receive a single dose of 13vPnC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine (13vPnC) | Biological | 0.5 mL intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. | Day 28 |
| Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5). | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landspitali University Hospital | Hringbraut | Reykjavik | 101 | Iceland | ||
| Midstod Heilsuverndar barna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24300594 | Derived | Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | PCV/23vPS/13vPnC | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). |
| FG001 | PCV/PCV/13vPnC | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCV/23vPS/13vPnC | For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination | Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. | Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 28 |
|
Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | PCV/23vPS/13vPnC | For this study, participants received a single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Primary analysis based on evaluable immunogenicity population as per analysis plan change.Data for a participant reported in PCV/23vPS/13vPnC instead of PCV/PCV/13vPnC due to data entry error on case report form;this did not affect result conclusion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood draw |
| Procedure |
Collection of 10 mL of blood |
|
| Antibody Response Measured 1 Month After Vaccination (OPA) | Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | Day 28 |
| Day 28 |
| Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Day 1 through Day 4 |
| Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category. | Day 1 through Day 4 |
| Reykjavik |
| 109 |
| Iceland |
| BG001 | PCV/PCV/13vPnC | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| PCV/23vPS/13vPnC |
For this study, participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly. Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). |
| OG001 | PCV/PCV/13vPnC | For this study, participants received a single 0.5 mL dose of 13vPnC administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). |
|
|
|
| Primary | Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination | Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. | Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 28 |
|
|
|
|
| Secondary | Antibody Response Measured 1 Month After Vaccination (Avidity Assay) | Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5). | Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | AI | Day 28 |
|
|
|
|
| Secondary | Antibody Response Measured 1 Month After Vaccination (OPA) | Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | GMT | Day 28 |
|
|
|
|
| Other Pre-specified | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination | Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw. | Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Day 28 |
|
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination | Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days and "number analyzed" signifies participants reporting the specific characteristic. | Posted | Number | Percentage of participants | Day 1 through Day 4 |
|
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination | Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category. | Safety; N=number of participants reporting yes for at least 1 day or no for all days and number analyzed signifies participants reporting the specific characteristic. | Posted | Number | Percentage of participants | Day 1 through Day 4 |
|
|
|
|
| 0 |
| 50 |
| 44 |
| 50 |
| EG001 | PCV/PCV/13vPnC | For this study, participants received a single 0.5 mL dose of 13vPnC, administered intramuscularly. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5. | 0 | 39 | 30 | 39 |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Redness (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Fever ≥ 38°C but ≤ 39°C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever > 39°C but ≤ 40°C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever > 40°C | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment |
|
| Rash | General disorders | Systemic Events | Systematic Assessment |
|
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.
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Common Serotype 9V |
|
| Common Serotype 14 |
|
| Common Serotype 18C |
|
| Common Serotype 19F |
|
| Common Serotype 23F |
|
| Additional Serotype 1 |
|
| Additional Serotype 3 |
|
| Additional Serotype 5 |
|
| Additional Serotype 6A |
|
| Additional Serotype 7F |
|
| Additional Serotype 19A |
|
| Difference in proportions (percentage) |
| 0.0 |
| 2-Sided |
| 95 |
| -7.5 |
| 9.7 |
| Superiority or Other (legacy) |
| Comparison between treatments for common serotype 9V | Difference in proportions (percentage) | 0.0 | 2-Sided | 95 | -7.5 | 9.7 | Superiority or Other (legacy) |
| Comparison between treatments for common serotype 14 | Difference in proportions (percentage) | 0.0 | 2-Sided | 95 | -7.5 | 9.7 | Superiority or Other (legacy) |
| Comparison between treatments for common serotype 18C | Difference in proportions (percentage) | 0.0 | 2-Sided | 95 | -7.4 | 10.0 | Superiority or Other (legacy) |
| Comparison between treatments for common serotype 19F | Difference in proportions (percentage) | 0.0 | 2-Sided | 95 | -7.5 | 10.0 | Superiority or Other (legacy) |
| Comparison between treatments for common serotype 23F | Difference in proportions (percentage) | -2.0 | 2-Sided | 95 | -10.8 | 8.1 | Superiority or Other (legacy) |
| Comparison between treatments for additional serotype 1 | Difference in proportions (percentage) | 2.7 | 2-Sided | 95 | -5.0 | 14.2 | Superiority or Other (legacy) |
| Comparison between treatments for additional serotype 3 | Difference in proportions (percentage) | -2.0 | 2-Sided | 95 | -11.1 | 7.9 | Superiority or Other (legacy) |
| Comparison between treatments for additional serotype 5 | Difference in proportions (percentage) | 0.7 | 2-Sided | 95 | -8.5 | 12.2 | Superiority or Other (legacy) |
| Comparison between treatments for additional serotype 6A | Difference in proportions (percentage) | 0.0 | 2-Sided | 95 | -7.3 | 9.5 | Superiority or Other (legacy) |
| Comparison between treatments for additional serotype 7F | Difference in proportions (percentage) | -2.0 | 2-Sided | 95 | -11.3 | 7.7 | Superiority or Other (legacy) |
| Comparison between treatments for additional serotype 19A | Difference in proportions (percentage) | 0.0 | 2-Sided | 95 | -7.3 | 9.5 | Superiority or Other (legacy) |
| Common serotype 6B |
|
| Common serotype 19F |
|
| Common serotype 23F |
|
Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). |
| Ratio of geometric means |
| 0.32 |
| 2-Sided |
| 95 |
| 0.23 |
| 0.44 |
CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC). |
| Superiority or Other (legacy) |
| Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of geometric means | 0.44 | 2-Sided | 95 | 0.29 | 0.67 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of geometric means | 0.88 | 2-Sided | 95 | 0.61 | 1.27 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of geometric means | 0.47 | 2-Sided | 95 | 0.34 | 0.65 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Common Serotype 9V |
|
| Common Serotype 14 |
|
| Common Serotype 18C |
|
| Common Serotype 19F |
|
| Common Serotype 23F |
|
| Additional Serotype 1 |
|
| Additional Serotype 3 |
|
| Additional Serotype 5 |
|
| Additional Serotype 6A |
|
| Additional Serotype 7F |
|
| Additional Serotype 19A |
|
Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). |
| Ratio of GMTs |
| 1.0 |
| 2-Sided |
| 95 |
| 0.68 |
| 1.38 |
CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). |
| Superiority or Other (legacy) |
| Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 1.0 | 2-Sided | 95 | 0.51 | 1.81 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 1.0 | 2-Sided | 95 | 0.67 | 1.48 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.6 | 2-Sided | 95 | 0.33 | 0.98 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 1.1 | 2-Sided | 95 | 0.72 | 1.56 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.6 | 2-Sided | 95 | 0.39 | 0.99 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.2 | 2-Sided | 95 | 0.12 | 0.32 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.8 | 2-Sided | 95 | 0.56 | 1.18 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.4 | 2-Sided | 95 | 0.21 | 0.63 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 1.4 | 2-Sided | 95 | 0.88 | 2.25 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.7 | 2-Sided | 95 | 0.48 | 1.14 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMTs | 0.8 | 2-Sided | 95 | 0.54 | 1.20 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Common serotype 9V |
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| Common serotype 14 |
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| Common serotype 18C |
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| Common serotype 19F |
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| Common serotype 23F |
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| Additional serotype 1 |
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| Additional serotype 3 |
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| Additional serotype 5 |
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| Additional serotype 6A |
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| Additional serotype 7F |
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| Additional serotype 19A |
|
Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). |
| Ratio of GMCs |
| 0.71 |
| 2-Sided |
| 95 |
| 0.44 |
| 1.15 |
CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). |
| Superiority or Other (legacy) |
| Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.58 | 2-Sided | 95 | 0.45 | 0.75 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.77 | 2-Sided | 95 | 0.48 | 1.24 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.57 | 2-Sided | 95 | 0.38 | 0.85 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.84 | 2-Sided | 95 | 0.56 | 1.27 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.64 | 2-Sided | 95 | 0.44 | 0.95 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.27 | 2-Sided | 95 | 0.18 | 0.40 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 1.14 | 2-Sided | 95 | 0.76 | 1.72 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.36 | 2-Sided | 95 | 0.25 | 0.51 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.79 | 2-Sided | 95 | 0.55 | 1.14 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.89 | 2-Sided | 95 | 0.61 | 1.28 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Ratio of GMCs | 0.86 | 2-Sided | 95 | 0.60 | 1.23 | CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). | Superiority or Other (legacy) |
| Tenderness: Significant |
|
|
| Redness: Any |
|
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| Redness: Mild |
|
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| Redness: Moderate |
|
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| Redness: Severe |
|
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| Swelling: Any |
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| Swelling: Mild |
|
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| Swelling: Moderate |
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| Swelling: Severe |
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|
| 0.380 |
| 2-Sided |
| Superiority or Other (legacy) |
| Comparison between treatments for any redness | Fisher Exact | 0.135 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for mild redness | Fisher Exact | 0.520 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for moderate redness | Fisher Exact | 0.283 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for severe redness | Fisher Exact | 0.225 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for any swelling | Fisher Exact | 0.202 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for mild swelling | Fisher Exact | 0.294 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for moderate swelling | Fisher Exact | 0.175 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for severe swelling | Fisher Exact | 0.314 | 2-Sided | Superiority or Other (legacy) |
| Decreased appetite |
|
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| Irritability |
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| Increased sleep |
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| Decreased sleep |
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| Rash |
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| Fisher Exact |
| > .99 |
| 2-Sided |
| Superiority or Other (legacy) |
| Comparison between treatments for irritability | Fisher Exact | 0.543 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for increased sleep | Fisher Exact | 0.233 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for decreased sleep | Fisher Exact | 0.198 | 2-Sided | Superiority or Other (legacy) |
| Comparison between treatments for rash | Fisher Exact | 0.628 | 2-Sided | Superiority or Other (legacy) |