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| ID | Type | Description | Link |
|---|---|---|---|
| B1851016 |
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This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1 dose (0.5 mL), IM of 13vPnC vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine | Antibody GMC as measured by microgram/millilitre (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% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | One month after vaccination |
| Percentage of Participants With Prespecified Local Reactions | Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category. | Seven days after vaccination |
| Percentage of Participants With Prespecified Systemic Events | Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category. | Seven days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine | IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ancenis | 44150 | France | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 263 participants who had received a 4-dose vaccination series of pneumococcal conjugate vaccine as part of study 6096A1-008 (NCT00366678) were enrolled for this study. Out of those 1 participant was a screen failure and was not included in results.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC/13vPnC/13vPnC | Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine. |
| FG001 | 7vPnC/7vPnC/13vPnC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Up to 7 days before vaccination |
| Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine | IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Four to seven days after vaccination |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine | Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | Up to 7 days before vaccination |
| Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine | Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. | One month after vaccination |
| Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine | Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants. | One month after vaccination |
| Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine | Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants. | One month after vaccination |
| Bondues |
| 59910 |
| France |
| Pfizer Investigational Site | Brest | 29200 | France |
| Pfizer Investigational Site | Châlons-en-Champagne | 51100 | France |
| Pfizer Investigational Site | Draguignan | 83300 | France |
| Pfizer Investigational Site | Essey-lès-Nancy | 54270 | France |
| Pfizer Investigational Site | Écully | 69130 | France |
| Pfizer Investigational Site | Floirac | 33270 | France |
| Pfizer Investigational Site | Garges Les Gonesses | 95140 | France |
| Pfizer Investigational Site | Joué-lès-Tours | 37300 | France |
| Pfizer Investigational Site | Le Havre | 76600 | France |
| Pfizer Investigational Site | Lingolsheim | 67380 | France |
| Pfizer Investigational Site | Lyon | 69007 | France |
| Pfizer Investigational Site | Maromme | 76150 | France |
| Pfizer Investigational Site | Moûtiers | 73600 | France |
| Pfizer Investigational Site | Nancy | 54000 | France |
| Pfizer Investigational Site | Nice | 06300 | France |
| Pfizer Investigational Site | Olonne-sur-Mer | 85340 | France |
| Pfizer Investigational Site | Strasbourg | 67000 | France |
| Pfizer Investigational Site | Strasbourg | 67100 | France |
| Pfizer Investigational Site | Talence | 33400 | France |
| Pfizer Investigational Site | Thionville | 57100 | France |
| Pfizer Investigational Site | Tours | 37000 | France |
| Pfizer Investigational Site | Villers-lès-Nancy | 54600 | France |
| Pfizer Investigational Site | Vitry-sur-Seine | 94400 | France |
Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine. |
| FG002 | 7vPnC/13vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC/13vPnC/13vPnC | Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine. |
| BG001 | 7vPnC/7vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine. |
| BG002 | 7vPnC/13vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine | Antibody GMC as measured by microgram/millilitre (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% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | One month after vaccination |
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| Primary | Percentage of Participants With Prespecified Local Reactions | Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category. | Safety population: all participants who received the single dose of 13vPnC vaccination. "n" is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively. | Posted | Number | Percentage of Participants | Seven days after vaccination |
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| Primary | Percentage of Participants With Prespecified Systemic Events | Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category. | Safety population: all participants who received the single dose of 13vPnC vaccination. "n" is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively. | Posted | Number | Percentage of Participants | Seven days after vaccination |
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| Secondary | Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine | IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Up to 7 days before vaccination |
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| Secondary | Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine | IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Four to seven days after vaccination |
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| Secondary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine | Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are 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 analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | Up to 7 days before vaccination |
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| Secondary | Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine | Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are 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 analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | One month after vaccination |
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| Secondary | Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine | Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants. | The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month after vaccination |
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| Secondary | Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine | Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants. | The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month after vaccination |
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| Post-Hoc | Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine | Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. 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; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis. | Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype. | Posted | Number | 95% Confidence Interval | Percentage of Participants | One month after vaccination |
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AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Participants recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC).
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
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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 | 13vPnC/13vPnC/13vPnC | Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine. | 0 | 130 | 82 | 130 | ||
| EG001 | 7vPnC/7vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine. | 0 | 64 | 36 | 64 | ||
| EG002 | 7vPnC/13vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. | 0 | 64 | 39 | 64 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (Any) = present at site of vaccination |
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| Pain (Mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (Mild) = does not interfere with activity |
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| Pain (Moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (Moderate) = interferes with activity |
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| Pain (Severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (Severe) = prevents daily activity |
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| Swelling (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (Any) = present at site of vaccination |
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| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (Mild) = 0.5 - 2.0 cm |
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| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (Moderate) = 2.5 - 7.0 cm |
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| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (Severe) = >7.0 cm |
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| Redness (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (Any) = present at site of vaccination |
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| Redness (Mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (Mild) = 0.5 - 2.0 cm |
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| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (Moderate) = 2.5 - 7.0 cm |
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| Redness (Severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (Severe) = >7.0 cm |
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| Fever >= 38.0 degree C but <=39.0 degree C | General disorders | Systemic events | Systematic Assessment |
| |
| Fever >39.0 to <=40.0 degree C | General disorders | Systemic events | Systematic Assessment |
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| Fever >40.0 degree C | General disorders | Systemic events | Systematic Assessment |
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| Vomiting (Any) | General disorders | Systemic events | Systematic Assessment | Vomiting (Any) = present |
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| Vomiting (Mild) | General disorders | Systemic events | Systematic Assessment | Vomiting (Mild)= 1-2 times in 24 hours |
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| Vomiting (Moderate) | General disorders | Systemic events | Systematic Assessment | Vomiting (Moderate) = >2 times in 24 hours |
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| Vomiting (Severe) | General disorders | Systemic events | Systematic Assessment | Vomiting (Severe) = requires IV hydration |
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| Diarrhea (Any) | General disorders | Systemic events | Systematic Assessment | Diarrhea (Any) = present |
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| Diarrhea (Mild) | General disorders | Systemic events | Systematic Assessment | Diarrhea (Mild) = 2-3 loose stools in 24 hours |
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| Diarrhea (Moderate) | General disorders | Systemic events | Systematic Assessment | Diarrhea (Moderate) = 4-5 stools in 24 hours |
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| Diarrhea (Severe) | General disorders | Systemic events | Systematic Assessment | Diarrhea (Severe) = 6 or more loose stools in 24 hours |
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| Fatigue (Any) | General disorders | Systemic events | Systematic Assessment | Fatigue (Any) = present |
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| Fatigue (Mild) | General disorders | Systemic events | Systematic Assessment | Fatigue (Mild) = does not interfere with activity |
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| Fatigue (Moderate) | General disorders | Systemic events | Systematic Assessment | Fatigue (Moderate) = some interference with activity |
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| Fatigue (Severe) | General disorders | Systemic events | Systematic Assessment | Fatigue (Severe) = prevents daily routine activity |
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| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Male |
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| 9V |
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| 14 |
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| 18C |
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| 19F |
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| 23F |
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| 1 |
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| 3 |
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| 5 |
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| 6A |
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| 7F |
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| 19A |
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Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).
| GMC Ratio |
| 1.15 |
| 2-Sided |
| 95 |
| 0.87 |
| 1.52 |
| No |
| Superiority or Other |
| Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC Ratio | 1.42 | 2-Sided | 95 | 1.03 | 1.96 | No | Superiority or Other |
| Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 0.62 | 2-Sided | 95 | 0.46 | 0.84 | No | Superiority or Other |
| Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.89 | 2-Sided | 95 | 0.66 | 1.20 | No | Superiority or Other |
| Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.44 | 2-Sided | 95 | 1.02 | 2.04 | No | Superiority or Other |
| Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.04 | 2-Sided | 95 | 0.82 | 1.32 | No | Superiority or Other |
| Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.09 | 2-Sided | 95 | 0.86 | 1.39 | No | Superiority or Other |
| Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.05 | 2-Sided | 95 | 0.79 | 1.39 | No | Superiority or Other |
| Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.02 | 2-Sided | 95 | 0.77 | 1.34 | No | Superiority or Other |
| Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.04 | 2-Sided | 95 | 0.79 | 1.37 | No | Superiority or Other |
| Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.02 | 2-Sided | 95 | 0.74 | 1.40 | No | Superiority or Other |
| Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 0.75 | 2-Sided | 95 | 0.57 | 0.97 | No | Superiority or Other |
| Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.85 | 2-Sided | 95 | 0.65 | 1.11 | No | Superiority or Other |
| Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMCratio | 1.14 | 2-Sided | 95 | 0.84 | 1.56 | No | Superiority or Other |
| Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.37 | 2-Sided | 95 | 0.97 | 1.94 | No | Superiority or Other |
| Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.10 | 2-Sided | 95 | 0.78 | 1.55 | No | Superiority or Other |
| Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.80 | 2-Sided | 95 | 0.54 | 1.19 | No | Superiority or Other |
| Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 0.80 | 2-Sided | 95 | 0.61 | 1.05 | No | Superiority or Other |
| Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.95 | 2-Sided | 95 | 0.73 | 1.25 | No | Superiority or Other |
| Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.19 | 2-Sided | 95 | 0.87 | 1.64 | No | Superiority or Other |
| Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 3.62 | 2-Sided | 95 | 2.76 | 4.74 | No | Superiority or Other |
| Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.52 | 2-Sided | 95 | 0.40 | 0.68 | No | Superiority or Other |
| Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.14 | 2-Sided | 95 | 0.10 | 0.20 | No | Superiority or Other |
| Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.13 | 2-Sided | 95 | 0.80 | 1.59 | No | Superiority or Other |
| Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.87 | 2-Sided | 95 | 0.62 | 1.23 | No | Superiority or Other |
| Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.77 | 2-Sided | 95 | 0.52 | 1.15 | No | Superiority or Other |
| Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 3.49 | 2-Sided | 95 | 2.68 | 4.54 | No | Superiority or Other |
| Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.52 | 2-Sided | 95 | 0.40 | 0.68 | No | Superiority or Other |
| Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.15 | 2-Sided | 95 | 0.11 | 0.20 | No | Superiority or Other |
| Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.61 | 2-Sided | 95 | 1.15 | 2.23 | No | Superiority or Other |
| Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.24 | 2-Sided | 95 | 0.89 | 1.72 | No | Superiority or Other |
| Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.77 | 2-Sided | 95 | 0.53 | 1.13 | No | Superiority or Other |
| Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.63 | 2-Sided | 95 | 1.28 | 2.08 | No | Superiority or Other |
| Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.03 | 2-Sided | 95 | 0.81 | 1.30 | No | Superiority or Other |
| Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.63 | 2-Sided | 95 | 0.47 | 0.83 | No | Superiority or Other |
| Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC). | GMC ratio | 1.99 | 2-Sided | 95 | 1.51 | 2.63 | No | Superiority or Other |
| Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 1.04 | 2-Sided | 95 | 0.79 | 1.37 | No | Superiority or Other |
| Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC). | GMC ratio | 0.52 | 2-Sided | 95 | 0.38 | 0.72 | No | Superiority or Other |
| OG002 | 7vPnC/13vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
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| OG002 | 7vPnC/13vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
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| 7vPnC/13vPnC/13vPnC |
Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
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| 7vPnC/13vPnC/13vPnC |
Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
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Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
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| OG002 | 7vPnC/13vPnC/13vPnC | Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine. |
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