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| ID | Type | Description | Link |
|---|---|---|---|
| B1851013 |
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This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent Pneumoccocal Conjugate Vaccine | Biological | 2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. | 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here "Number of participants analyzed" signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category. |
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 | Birmingham | Alabama | 35233 | United States | ||
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Up to 6-month Follow-up(FU) |
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| Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 |
| Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. | Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
| Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category. | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
| Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category. | 1 year after 13vPnC Dose 2 |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category. | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category. | 1 year after 13vPnC Dose 2 |
| Within 7 days after 13vPnC Dose 1 |
| Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category. | Within 7 days after 13vPnC Dose 2 |
| Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category. | Within 7 days after 13vPnC Dose 1 |
| Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category. | Within 7 days after 13vPnC Dose 2 |
| Louisville |
| Kentucky |
| 40202-3830 |
| United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10467 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37232 | United States |
| Pfizer Investigational Site | Cairo | Cairo Governorate | 11361 | Egypt |
| Pfizer Investigational Site | Cairo | Cairo Governorate | 11511 | Egypt |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Orbassano (TO) | 10043 | Italy |
| Pfizer Investigational Site | Roma | 00165 | Italy |
| Pfizer Investigational Site | Beirut | Lebanon | 2833-7401 | Lebanon |
| Pfizer Investigational Site | Beirut | Lebanon |
| Pfizer Investigational Site | Riyadh | Saudi | Saudi Arabia |
| Pfizer Investigational Site | Manchester | Cheshire | M27 4HA | United Kingdom |
| Pfizer Investigational Site | London | United Kingdom | E1 1BB | United Kingdom |
| Pfizer Investigational Site | London | SE1 7RH | United Kingdom |
| Pfizer Investigational Site | London | SE1 9RT | United Kingdom |
| Pfizer Investigational Site | London | SE5 9RS | United Kingdom |
| Pfizer Investigational Site | London | SW17 0RE | United Kingdom |
| Vaccinated Dose 1 |
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| Vaccinated Dose 2 |
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| COMPLETED |
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| NOT COMPLETED |
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| After 6-month FU to 1-year FU |
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All-available immunogenicity (AAI) population included all participants who had at least 1 valid and determinate pneumococcal assay result for the planned analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC | Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| 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 | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. | Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | fold rise | 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2 |
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| Secondary | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category. | Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 |
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| Secondary | Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. | Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
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| Secondary | Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category. | Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | ratio of GMFR | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
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| Secondary | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category. | Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter (mcg/mL) | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
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| Secondary | Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category. | Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 year after 13vPnC Dose 2 |
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| Secondary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category. | Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | titer | Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2 |
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| Secondary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 | Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category. | Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids). | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 year after 13vPnC Dose 2 |
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| Other Pre-specified | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here "Number of participants analyzed" signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category. | Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available. | Posted | Number | percentage of participants | Within 7 days after 13vPnC Dose 1 |
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| Other Pre-specified | Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2 | Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category. | Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available. | Posted | Number | percentage of participants | Within 7 days after 13vPnC Dose 2 |
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| Other Pre-specified | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1 | Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category. | Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available. | Posted | Number | percentage of participants | Within 7 days after 13vPnC Dose 1 |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2 | Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and "N" signifies those participants who reported "Yes" for at least 1 day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category. | Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available. | Posted | Number | percentage of participants | Within 7 days after 13vPnC Dose 2 |
|
SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2
Safety populations: participants who received at least 1 dose and had safety data available. SAEs and AEs were grouped by system organ class and summarized. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
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 Dose 1 | Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2. | 40 | 158 | 133 | 158 | ||
| EG001 | 13vPnC Dose 2 | Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw. | 11 | 140 | 100 | 140 | ||
| EG002 | 6-Month Follow-up | Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact. | 28 | 147 | 1 | 147 | ||
| EG003 | 1-Year Follow-up | Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2. | 16 | 87 | 1 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute chest syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancreatic calcification | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site movement impairment | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Moyamoya disease | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasal congestion | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Pain (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Pain (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Pain (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Redness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Redness (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Redness (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Swelling (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Fever >=38°C but =<38.4°C | General disorders | Systemic Events | Systematic Assessment |
| |
| Fever >38.4°C but =<38.9°C | General disorders | Systemic Events | Systematic Assessment |
| |
| Fever >38.9°C but =<40.0°C | General disorders | Systemic Events | Systematic Assessment |
| |
| Fever >40.0°C | General disorders | Systemic Events | Systematic Assessment |
| |
| Vomiting (Any) | General disorders | Systemic Events | Systematic Assessment |
| |
| Vomiting (Mild) | General disorders | Systemic Events | Systematic Assessment |
| |
| Vomiting (Moderate) | General disorders | Systemic Events | Systematic Assessment |
| |
| Vomiting (Severe) | General disorders | Systemic Events | Systematic Assessment |
| |
| Diarrhea (Any) | General disorders | Systemic Events | Systematic Assessment |
| |
| Diarrhea (Mild) | General disorders | Systemic Events | Systematic Assessment |
| |
| Diarrhea (Moderate) | General disorders | Systemic Events | Systematic Assessment |
| |
| Diarrhea (Severe) | General disorders | Systemic Events | Systematic Assessment |
| |
| Headache (Any) | General disorders | Systemic Events | Systematic Assessment |
| |
| Headache (Mild) | General disorders | Systemic Events | Systematic Assessment |
| |
| Headache (Moderate) | General disorders | Systemic Events | Systematic Assessment |
| |
| Headache (Severe) | General disorders | Systemic Events | Systematic Assessment |
| |
| Fatigue (Any) | General disorders | Systemic Events | Systematic Assessment |
| |
| Fatigue (Mild) | General disorders | Systemic Events | Systematic Assessment |
| |
| Fatigue (Moderate) | General disorders | Systemic Events | Systematic Assessment |
| |
| Fatigue (Severe) | General disorders | Systemic Events | Systematic Assessment |
| |
| Muscle pain (Any) | General disorders | Systemic Events | Systematic Assessment |
| |
| Muscle pain (Mild) | General disorders | Systemic Events | Systematic Assessment |
| |
| Muscle pain (Moderate) | General disorders | Systemic Events | Systematic Assessment |
| |
| Muscle pain (Severe) | General disorders | Systemic Events | Systematic Assessment |
| |
| Joint pain (Any) | General disorders | Systemic Events | Systematic Assessment |
| |
| Joint pain (Mild) | General disorders | Systemic Events | Systematic Assessment |
| |
| Joint pain (Moderate) | General disorders | Systemic Events | Systematic Assessment |
| |
| Joint pain (Severe) | General disorders | Systemic Events | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Title | Measurements |
|---|---|
|
| Serotype 14 (N = 137) |
|
| Serotype 18C (N = 137) |
|
| Serotype 19F (N = 136) |
|
| Serotype 23F (N = 135) |
|
| Serotype 1 (N = 137) |
|
| Serotype 3 (N = 134) |
|
| Serotype 5 (N = 136) |
|
| Serotype 6A (N = 136) |
|
| Serotype 7F (N = 137) |
|
| Serotype 19A (N = 137) |
|
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