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| ID | Type | Description | Link |
|---|---|---|---|
| B1851022 | Other Identifier | Alias Study Number | |
| 2009-012087-13 | EudraCT Number |
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People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13vPnC | Biological | 0.5mL 13vPnC dose will be administered intramuscularly into the left limb at visits 1,2,3 and 5. Starting 3-6 months after HSCT 3 doses given at monthly intervals. 4th dose given 6 months after 3rd dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants | 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 3 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 before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). |
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 |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States | ||
| Steven and Alexandra Cohen Children's Medical Center of New York |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25870329 | Derived | Cordonnier C, Ljungman P, Juergens C, Maertens J, Selleslag D, Sundaraiyer V, Giardina PC, Clarke K, Gruber WC, Scott DA, Schmoele-Thoma B; 3003 Study Group. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged >/=2 years: an open-label study. Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC, 23vPS (Pediatric Participants) | Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 23vPS | Biological | 0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC. |
|
| 1 month after 13vPnC Dose 3 |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | 1 month after 13vPnC Dose 4 |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | 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 3 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 both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3 |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | 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 4 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 both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws. | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4 |
| Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | 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 3 to 1 month after 13vPnC Dose 4 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 both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws. | 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4 |
| Within 14 days after 13vPnC Dose 1 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Within 14 days after 13vPnC Dose 2 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Within 14 days after 13vPnC Dose 3 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Within 14 days after 13vPnC Dose 4 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Within 14 days after 13vPnC Dose 1 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Within 14 days after 13vPnC Dose 2 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Within 14 days after 13vPnC Dose 3 |
| Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Within 14 days after 13vPnC Dose 4 |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| Columbia University Medical Center Research Pharmacy | New York | New York | 10032 | United States |
| Columbia University Medical Center-Presbyterian Hospital Building | New York | New York | 10032 | United States |
| Columbia University/Taub Institute Irving Center for Clinical Research | New York | New York | 10032 | United States |
| New York-Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Universitair Ziekenhuis Gent | Belgium | 9000 | Belgium |
| Algemeen Ziekenhuis St.-Jan A.V. | Bruges | 8000 | Belgium |
| Clinical University St Luc | Brussels | 1200 | Belgium |
| Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Liege | Liège | 4000 | Belgium |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Fakultni nemocnice Brno/Interni hematoonkologicka klinika | Bmo | 625 00 | Czechia |
| Fakultni nemocnice v Motole | Prague | 15006 | Czechia |
| Hôpital Jean Minjoz | Besançon | 25000 | France |
| Hopital Henri Mondor | Créteil | 94000 | France |
| Hôpital Henri Mondor, Pharmacie | Créteil | 94010 | France |
| Hôpital Saint Louis | Paris | 75010 | France |
| CHRU Robert Debré | Paris | 75019 | France |
| Hopital Robert Debre | Paris | 75019 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Robert Debre - Service Pharmacie | Paris | 75935 | France |
| Charite Universitaetsmedizin | Berlin | 13353 | Germany |
| Clinical Trial Center North MediGate GmbH | Hamburg | 20246 | Germany |
| Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie | Hamburg | 20246 | Germany |
| Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH | Hamburg | 20246 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum | Hamburg | 20246 | Germany |
| Universitatsklinikum Jena | Jena | 07740 | Germany |
| "Universitaetsklinikum Muenster, | Münster | 48149 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| UMC Utrecht, Wilhelmina Kinder Ziekenhuis | Utrecht | 3584 EA | Netherlands |
| Klinika Hematologii i Transplantologii | Gdansk | 80-952 | Poland |
| NZOZ "HIPOKRATES-II" Sp. z o.o. | Krakow | 31-223 | Poland |
| Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej | Wroclaw | 50-345 | Poland |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Infantil Niño Jesús | Madrid | 28009 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Karolinska Universitetssjukhuset Huddinge | Huddinge | 141 86 | Sweden |
| Universitetssjukhuset i Lund, Barnonkologen Avd 64 | Lund | 221 85 | Sweden |
| Karolinska University Hospital Huddinge | Stockholm | 141 86 | Sweden |
| Akademiska Sjukhuset, Infektionskliniken | Uppsala | 751 85 | Sweden |
| FG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| Vaccinated 13vPnC Dose 1 |
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| Vaccinated 13vPnC Dose 2 |
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| Vaccinated 13vPnC Dose 3 |
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| Vaccinated 13vPnC Dose 4 |
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| Vaccinated 23vPS Dose |
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| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least 1 dose of investigational product and had safety data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC, 23vPS (Pediatric Participants) | Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| BG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| BG002 | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants | 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 3 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 before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. | Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3 |
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| Secondary | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter (mcg/mL) | 1 month after 13vPnC Dose 3 |
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| Secondary | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. | Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 month after 13vPnC Dose 4 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants | 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 3 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 both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. | Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | 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 4 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 both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws. | Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4 |
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| Secondary | Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants | 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 3 to 1 month after 13vPnC Dose 4 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 both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws. | Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4 |
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| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 1 |
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| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 2 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3 | 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 3 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4 | 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 (0.5 to 2.0 centimeters [cm] for participants aged 2 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 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 4 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 1 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 2 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 3 |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4 | Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) 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 with activity); 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). | Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after 13vPnC Dose 4 |
|
AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after 13vPnC vaccination)
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Participants who received specified dose and had safety data available were evaluable for safety.
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 to 13vPnC Dose 3 Blood Draw | All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3. | 58 | 247 | 203 | 247 | ||
| EG001 | 13vPnC Dose 3 Blood Draw to 13vPnC Dose 4 | All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4. | 42 | 221 | 89 | 221 | ||
| EG002 | 13vPnC Dose 4 | All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4. | 11 | 192 | 127 | 192 | ||
| EG003 | 23vPS Dose | All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose. | 11 | 184 | 93 | 184 | ||
| EG004 | Follow-up | All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up. | 28 | 247 | 19 | 247 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Warm type haemolytic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease in intestine | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease in liver | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Haemophilus sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hepatic candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Thrombophlebitis septic | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA | Non-systematic Assessment |
| |
| False positive investigation result | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Plasma cell myeloma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Refractory anaemia with an excess of blasts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Juvenile chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Uncoded | General disorders | No coding system | Non-systematic Assessment | Term was not coded because it violated sponsor's coding conventions. |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypergammaglobulinaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Dilatation ventricular | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myotonic dystrophy | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Ichthyosis | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Oestrogen deficiency | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Allergic keratitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Orbital oedema | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aptyalism | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oral mucosal discolouration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tongue coated | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oral lichen planus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Catheter site rash | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
| |
| Complication of device removal | General disorders | MedDRA | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site movement impairment | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site haematoma | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Spinal pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site swelling | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site rash | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease in liver | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease in skin | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic graft versus host disease in liver | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Graft versus host disease in intestine | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Genital infection fungal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory moniliasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Streptococcal urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Toxoplasmosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Trichosporon infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Conjunctival scar | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Drug administration error | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Blood testosterone decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Human herpes virus 6 serology positive | Investigations | MedDRA | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Thyroxine decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Cystogram | Investigations | MedDRA | Non-systematic Assessment |
| |
| Ejection fraction abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Vitamin K deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Haemochromatosis | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Precursor B-lymphoblastic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cranial nerve palsies multiple | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Genital discharge | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal plaque | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Lichenification | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Perivascular dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pityriasis rubra pilaris | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Vasodilatation | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Redness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Redness (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Redness (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Swelling (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Pain (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Pain (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Pain (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Pain (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Redness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Redness (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Redness (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Swelling (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Pain (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Pain (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Pain (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Pain (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Redness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Redness (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Redness (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Swelling (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Pain (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Pain (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Pain (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Pain (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 3 |
|
| Fever >=38 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fever >=38, <38.5 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fever >=38.5, <39 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fever >=39, =<40 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fatigue (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fatigue (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fatigue (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fatigue (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Headache (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Headache (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Headache (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Headache (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Vomiting (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Vomiting (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Vomiting (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Vomiting (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Diarrhea (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Diarrhea (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Diarrhea (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Diarrhea (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Muscle pain (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Muscle pain (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Muscle pain (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Muscle pain (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Joint pain (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Joint pain (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Joint pain (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Joint pain (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fever >=38 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fever >=38, <38.5 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fever >=38.5, <39 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fever >=39, =<40 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fatigue (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fatigue (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fatigue (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fatigue (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Headache (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Headache (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Headache (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Headache (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Vomiting (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Vomiting (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Vomiting (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Vomiting (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Diarrhea (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Diarrhea (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Diarrhea (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Diarrhea (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Muscle pain (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Muscle pain (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Muscle pain (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Muscle pain (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Joint pain (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Joint pain (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Joint pain (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Joint pain (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fever >=38 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fever >=38, <38.5 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fever >=38.5, <39 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fever >=39, =<40 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fatigue (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fatigue (Mild) | Skin and subcutaneous tissue disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fatigue (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Fatigue (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Headache (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Headache (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Headache (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Headache (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Vomiting (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Vomiting (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Vomiting (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Diarrhea (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Diarrhea (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Diarrhea (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Diarrhea (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Muscle pain (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Muscle pain (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Muscle pain (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Muscle pain (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Joint pain (Any) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Joint pain (Mild) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Joint pain (Moderate) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Joint pain (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | 13vPnC Dose 2 |
|
| Fever >40 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 1 and Dose 4 |
|
| Fever >40 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 2 |
|
| Fever >40 degrees C | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Vomiting (Severe) | General disorders | Systemic Events | Systematic Assessment | 13vPnC Dose 3 |
|
| Cholestasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Male |
|
| Title | Measurements |
|---|---|
|
| Serotype 5 (n=194) |
|
| Serotype 6A (n=195) |
|
| Serotype 6B (n=192) |
|
| Serotype 7F (n=195) |
|
| Serotype 9V (n=196) |
|
| Serotype 14 (n=197) |
|
| Serotype 18C (n=196) |
|
| Serotype 19A (n=196) |
|
| Serotype 19F (n=195) |
|
| Serotype 23F (n=197) |
|
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
|
|
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
|
|
| 13vPnC, 23vPS (Adult Participants) |
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
|
|
| 13vPnC, 23vPS (Adult Participants) |
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
|
|
| 13vPnC, 23vPS (Adult Participants) |
Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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| OG001 | 13vPnC, 23vPS (Adult Participants) | Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
| OG002 | 13vPnC, 23vPS (All Participants) | All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4. |
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