Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000482-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.
It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidose Vial Group | Experimental | Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL |
|
| Single-Dose Syringe Group | Active Comparator | Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype. | 1 month after the infant series |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype. | 1 month after the infant series |
| Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category. | Within 5 days after Dose 1(Day 2 to Day 6) of the infant series |
| Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Council Unit, The Gambia | Fajara | The Gambia, West Africa | 000273 | The Gambia | ||
| Fajikunda Major Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28479175 | Derived | Idoko OT, Mboizi RB, Okoye M, Laudat F, Ceesay B, Liang JZ, Le Dren-Narayanin N, Jansen KU, Gurtman A, Center KJ, Scott DA, Kampmann B, Roca A. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial. Vaccine. 2017 May 31;35(24):3256-3263. doi: 10.1016/j.vaccine.2017.04.049. Epub 2017 May 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Total number of participants screened were 526, out of which 500 were enrolled in the study. The study was conducted in Gambia which started on 09 January 2014 and completed on 01 September 2014.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC Multi-dose Vial (MDV) | Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age. |
| FG001 | 13vPnC Single-Dose Syringe (SDS) | Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least 1 dose of investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC Multi-dose Vial (MDV) | Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age. |
| BG001 | 13vPnC Single-Dose Syringe (SDS) |
| 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 Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group | Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype. | Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after the infant series |
|
Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC MDV: Informed Consent to Dose 1 | Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden infant death syndrome | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 13-valent pneumococcal conjugate vaccine | Biological | Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2. |
|
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category. |
| Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series |
| Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category. | Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series |
| Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 5 days after Dose 1 (Day 2 to Day 6) of infant series |
| Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 5 days after Dose 2 (Day 2 to Day 6) of infant series |
| Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 5 days after Dose 3 (Day 2 to Day 6) of infant series |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state | Dose 1 up to 28 to 42 days after dose 3 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm. | Informed consent up to Dose 1 |
| 1 month after the infant series |
| Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category. | 1 month after the infant series |
| Ksmd |
| The Gambia |
| The Gambia |
| No longer met eligibility criteria |
|
| Death |
|
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age. |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| 13vPnC Multi-dose Vial (MDV) |
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age. |
| OG001 | 13vPnC Single-Dose Syringe (SDS) | Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age. |
|
|
|
| Primary | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group | Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype. | Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter (mcg/mL) | 1 month after the infant series |
|
|
|
|
| Primary | Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category. | Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. | Posted | Number | participants | Within 5 days after Dose 1(Day 2 to Day 6) of the infant series |
|
|
|
| Primary | Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category. | Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days and 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. | Posted | Number | participants | Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series |
|
|
|
| Primary | Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group | Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category. | Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. | Posted | Number | participants | Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series |
|
|
|
| Primary | Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group | Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event. | Posted | Number | participants | Within 5 days after Dose 1 (Day 2 to Day 6) of infant series |
|
|
|
| Primary | Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group | Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event. | Posted | Number | participants | Within 5 days after Dose 2 (Day 2 to Day 6) of infant series |
|
|
|
| Primary | Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group | Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event. | Posted | Number | participants | Within 5 days after Dose 3 (Day 2 to Day 6) of infant series |
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series | An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state | Safety population included all participants who received at least 1 dose of study vaccine. | Posted | Number | participants | Dose 1 up to 28 to 42 days after dose 3 |
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 | An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm. | Safety population: participants who received at least 1 dose of study vaccine. Here "N"= participants evaluable for this outcome measure. | Posted | Number | participants | Informed consent up to Dose 1 |
|
|
|
| Secondary | Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series | Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype. | Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after the infant series |
|
|
|
|
| Secondary | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series | Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category. | Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group. | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 month after the infant series |
|
|
|
|
| 0 |
| 250 |
| 2 |
| 250 |
| EG001 | 13vPnC SDS: Informed Consent to Dose 1 | Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1. | 0 | 250 | 0 | 250 |
| EG002 | 13vPnC MDV: After Dose 1 | Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2. | 0 | 250 | 113 | 250 |
| EG003 | 13vPnC SDS: After Dose 1 | Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2. | 0 | 250 | 107 | 250 |
| EG004 | 13vPnC MDV: After Dose 2 | Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3. | 0 | 249 | 114 | 249 |
| EG005 | 13vPnC SDS: After Dose 2 | Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3. | 0 | 248 | 99 | 248 |
| EG006 | 13vPnC MDV: After Dose 3 | Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks. | 1 | 247 | 97 | 247 |
| EG007 | 13vPnC SDS: After Dose 3 | Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks. | 0 | 244 | 102 | 244 |
| EG008 | Screened Only | Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization. | 0 | 26 | 9 | 26 |
| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Viral diarrhoea | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Injection site abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Tinea faciei | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Chest wall abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Umbilical granuloma | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Burns first degree | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Vaccination site swelling | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Ulcer | General disorders | MedDRA 17.1 | Non-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 |
|
| Tenderness: Any | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Tenderness: Mild | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Tenderness: Moderate | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Tenderness: Severe | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
|
| Fever: >=38.0 degree C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever: >=38.0 but <=39.0 degrees C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever: >39.0 but <=40.0 degrees C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever: >40.0 degrees C | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased appetite: Any | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased appetite: Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased appetite: Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Irritability: Any | General disorders | Systemic Events | Systematic Assessment |
|
| Irritability: Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Irritability: Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Irritability: Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Increased sleep: Any | General disorders | Systemic Events | Systematic Assessment |
|
| Increased sleep: Mild | General disorders | Systemic Events | Systematic Assessment |
|
| Increased sleep: Moderate | General disorders | Systemic Events | Systematic Assessment |
|
| Increased sleep: Severe | General disorders | Systemic Events | Systematic Assessment |
|
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Growth retardation | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-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.
| Serotype 4 (n=245,244) |
|
| Serotype 5 (n=245,244) |
|
| Serotype 6A (n=243,244) |
|
| Serotype 6B (n=245,244) |
|
| Serotype 7F (n=245,244) |
|
| Serotype 9V (n=245,244) |
|
| Serotype 14 (n=245,244) |
|
| Serotype 18C (n=245,244) |
|
| Serotype 19A (n=245,244) |
|
| Serotype 19F (n=245,244) |
|
| Serotype 23F (n=245,244) |
|
| Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 0.79 | 2-Sided | 97.5 | 0.71 | 0.90 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.00 | 2-Sided | 97.5 | 0.86 | 1.18 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.01 | 2-Sided | 97.5 | 0.85 | 1.19 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.03 | 2-Sided | 97.5 | 0.86 | 1.22 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.06 | 2-Sided | 97.5 | 0.82 | 1.36 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 0.94 | 2-Sided | 97.5 | 0.82 | 1.08 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.03 | 2-Sided | 97.5 | 0.87 | 1.21 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 0.96 | 2-Sided | 97.5 | 0.75 | 1.24 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.28 | 2-Sided | 97.5 | 1.09 | 1.49 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.01 | 2-Sided | 97.5 | 0.82 | 1.24 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.04 | 2-Sided | 97.5 | 0.85 | 1.26 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMC Ratio | 1.20 | 2-Sided | 97.5 | 0.98 | 1.48 | Yes | Non-Inferiority or Equivalence | Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion). |
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Tenderness: Any |
|
| Tenderness: Mild |
|
| Tenderness: Moderate |
|
| Tenderness: Severe |
|
| Redness: Moderate (n=247, 247) |
|
| Redness: Severe (n=247, 247) |
|
| Swelling: Any (n=247, 247) |
|
| Swelling: Mild (n=247, 247) |
|
| Swelling: Moderate (n=247, 247) |
|
| Swelling: Severe (n=247, 247) |
|
| Tenderness: Any (n=248, 247) |
|
| Tenderness: Mild (n=248, 247) |
|
| Tenderness: Moderate (n=247, 247) |
|
| Tenderness: Severe (n=247, 247) |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Tenderness: Any |
|
| Tenderness: Mild |
|
| Tenderness: Moderate |
|
| Tenderness: Severe |
|
| Fever: >39.0 but <=40.0 degrees C (n=248, 250) |
|
| Fever: >40.0 degrees C (n=248, 250) |
|
| Decreased appetite: Any (n=248, 250) |
|
| Decreased appetite: Moderate (n=248, 250) |
|
| Decreased appetite: Severe (n=248, 250) |
|
| Irritability: Any (n=249, 250) |
|
| Irritability: Mild (n=249, 250) |
|
| Irritability: Moderate (n=248, 250) |
|
| Irritability: Severe (n=248, 250) |
|
| Increased sleep: Any (n=248, 250) |
|
| Increased sleep: Mild (n=248, 250) |
|
| Increased sleep: Moderate (n=248, 250) |
|
| Increased sleep: Severe (n=248, 250) |
|
| Use of antipyretic medication (n=248, 250) |
|
| Fever: >39.0 but <=40.0 degrees C (n=247, 247) |
|
| Fever: >40.0 degrees C (n=247, 247) |
|
| Decreased appetite: Any(n=247, 247) |
|
| Decreased appetite: Moderate (n=247, 247) |
|
| Decreased appetite: Severe (n=247, 247) |
|
| Irritability: Any (n=248, 247) |
|
| Irritability: Mild (n=248, 247) |
|
| Irritability: Moderate (n=247, 247) |
|
| Irritability: Severe (n=247, 247) |
|
| Increased sleep: Any (n=247, 247) |
|
| Increased sleep: Mild (n=247, 247) |
|
| Increased sleep: Moderate (n=247, 247) |
|
| Increased sleep: Severe (n=247, 247) |
|
| Use of antipyretic medication (n=248, 247) |
|
| Fever: >39.0 but <=40.0 degrees C (n=246, 241) |
|
| Fever: >40.0 degrees C (n=246, 241) |
|
| Decreased appetite: Any (n=246, 242) |
|
| Decreased appetite: Moderate (n=246, 242) |
|
| Decreased appetite: Severe (n=246, 241) |
|
| Irritability: Any (n=246, 243) |
|
| Irritability: Mild (n=246, 242) |
|
| Irritability: Moderate (n=246, 242) |
|
| Irritability: Severe (n=246, 241) |
|
| Increased sleep: Any (n=246, 241) |
|
| Increased sleep: Mild (n=246, 241) |
|
| Increased sleep: Moderate (n=246, 241) |
|
| Increased sleep: Severe (n=246, 241) |
|
| Use of antipyretic medication (n=246, 241) |
|
| Title | Measurements |
|---|---|
|
| Serotype 4 (n=159,159) |
|
| Serotype 5 (n=160,159) |
|
| Serotype 6A (n=160,160) |
|
| Serotype 6B (n=156,155) |
|
| Serotype 7F (n=159,160) |
|
| Serotype 9V (n=158,160) |
|
| Serotype 14 (n=157,160) |
|
| Serotype 18C (n=159,160) |
|
| Serotype 19A (n=160,160) |
|
| Serotype 19F (n=158,159) |
|
| Serotype 23F (n=159,160) |
|
Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.
| percent difference |
| -1.2 |
| 2-Sided |
| 95 |
| -4.4 |
| 1.1 |
| No |
| Superiority or Other |
| Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | 0.0 | 2-Sided | 95 | -2.3 | 2.3 | No | Superiority or Other |
| Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | -2.4 | 2-Sided | 95 | -10.6 | 5.7 | No | Superiority or Other |
| Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | 0.0 | 2-Sided | 95 | -2.9 | 2.8 | No | Superiority or Other |
| Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | 0.0 | 2-Sided | 95 | -4.5 | 4.6 | No | Superiority or Other |
| Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | 0.0 | 2-Sided | 95 | -2.3 | 2.3 | No | Superiority or Other |
| Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | 4.7 | 2-Sided | 95 | -4.5 | 14.1 | No | Superiority or Other |
| Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | -7.8 | 2-Sided | 95 | -15.8 | -0.0 | No | Superiority or Other |
| Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | -0.0 | 2-Sided | 95 | -2.9 | 2.9 | No | Superiority or Other |
| Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | -1.9 | 2-Sided | 95 | -6.6 | 2.4 | No | Superiority or Other |
| Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | -0.7 | 2-Sided | 95 | -6.3 | 4.9 | No | Superiority or Other |
| Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed. | percent difference | -1.3 | 2-Sided | 95 | -5.8 | 3.0 | No | Superiority or Other |
| Serotype 4 (n=159,159) |
|
| Serotype 5 (n=160,159) |
|
| Serotype 6A (n=160,160) |
|
| Serotype 6B (n=156,155) |
|
| Serotype 7F (n=159,160) |
|
| Serotype 9V (n=158,160) |
|
| Serotype 14 (n=157,160) |
|
| Serotype 18C (n=159,160) |
|
| Serotype 19A (n=160,160) |
|
| Serotype 19F (n=158,159) |
|
| Serotype 23F (n=159,160) |
|
Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). |
| GMT Ratio |
| 0.8 |
| 2-Sided |
| 95 |
| 0.69 |
| 0.93 |
| No |
| Superiority or Other |
| Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 1.1 | 2-Sided | 95 | 0.89 | 1.39 | No | Superiority or Other |
| Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 1.0 | 2-Sided | 95 | 0.80 | 1.22 | No | Superiority or Other |
| Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 0.9 | 2-Sided | 95 | 0.70 | 1.06 | No | Superiority or Other |
| Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 1.0 | 2-Sided | 95 | 0.74 | 1.33 | No | Superiority or Other |
| Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 0.8 | 2-Sided | 95 | 0.70 | 1.00 | No | Superiority or Other |
| Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 1.0 | 2-Sided | 95 | 0.79 | 1.27 | No | Superiority or Other |
| Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 0.7 | 2-Sided | 95 | 0.48 | 1.08 | No | Superiority or Other |
| Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 1.7 | 2-Sided | 95 | 1.38 | 2.19 | No | Superiority or Other |
| Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 0.9 | 2-Sided | 95 | 0.74 | 1.16 | No | Superiority or Other |
| Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 0.9 | 2-Sided | 95 | 0.71 | 1.18 | No | Superiority or Other |
| Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS). | GMT Ratio | 0.9 | 2-Sided | 95 | 0.67 | 1.25 | No | Superiority or Other |