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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004915-38 | EudraCT Number | ||
| V114-017 | Other Identifier | Merck Protocol Number |
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This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2) |
|
| Prevnar 13â„¢ | Active Comparator | Participants will receive a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 | Biological | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13â„¢ | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13â„¢, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson. | Up to 5 days after Vaccination 1 |
| Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13â„¢ | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13â„¢, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | Up to 14 days after Vaccination 1 |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13â„¢ | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13â„¢, the percentage of serious adverse events of V114 compared with Prevnar 13â„¢ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | Up to Month 6 (before Vaccination 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAXâ„¢23 | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAXâ„¢23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. |
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Inclusion Criteria:
Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with ≥1 of the following risk conditions for pneumococcal disease:
Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinle Comprehensive Health Care Facility ( Site 0001) | Chinle | Arizona | 86503 | United States | ||
| Fort Defiance Center for American Indian Health ( Site 0002) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35146039 | Derived | Hammitt LL, Quinn D, Janczewska E, Pasquel FJ, Tytus R, Rajender Reddy K, Abarca K, Khaertynova IM, Dagan R, McCauley J, Cheon K, Pedley A, Sterling T, Tamms G, Musey L, Buchwald UK. Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY). Open Forum Infect Dis. 2021 Dec 18;9(3):ofab605. doi: 10.1093/ofid/ofab605. eCollection 2022 Mar. |
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 | Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). |
| FG001 | Prevnar 13â„¢ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 |
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| Prevnar 13â„¢ | Biological | 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose |
|
|
| PNEUMOVAXâ„¢23 | Biological | 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose |
|
|
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13â„¢ | The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | Day 30 |
| Up to 5 days after Vaccination 2 (Month 6) |
| Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAXâ„¢23 | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAXâ„¢23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | Up to 14 days after Vaccination 2 (Month 6) |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAXâ„¢23 | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAXâ„¢23, the percentage of serious adverse events of V114 compared with Prevnar 13â„¢ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | From Month 6 (before Vaccination 2) to Month 7 |
| Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | Day 30 |
| Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Activity for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. | Day 1 (Baseline) and Day 30 |
| GMFR in Serotype-specific IgG Day 1 to Day 30 | IgG for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. | Day 1 (Baseline) and Day 30 |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | Day 1 (Baseline) and Day 30 |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. | Day 1 (Baseline) and Day 30 |
| Geometric Mean Titer of Serotype-specific OPA at Month 7 | The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | Month 7 |
| Geometric Mean Concentration of Serotype-specific IgG at Month 7 | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. | Month 7 |
| GMFR in Serotype-specific OPA Day 1 to Month 7 | Activity for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. | Day 1 (Baseline) and Month 7 |
| GMFR in Serotype-specific IgG Day 1 to Month 7 | IgG for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. | Day 1 (Baseline) and Month 7 |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | Day 1 (Baseline) and Month 7 |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. | Day 1 (Baseline) and Month 7 |
| GMFR in Serotype-specific OPA Month 6 to Month 7 | Activity for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. | Month 6 (Baseline before Vaccination 2) and Month 7 |
| GMFR in Serotype-specific IgG Month 6 to Month 7 | IgG for the serotypes contained in Prevnar 13â„¢ and V114 and (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. | Month 6 (Baseline before Vaccination 2) and Month 7 |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | Month 6 (Baseline before Vaccination 2) and Month 7 |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. | Month 6 (Baseline before Vaccination 2) and Month 7 |
| Fort Defiance |
| Arizona |
| 86504 |
| United States |
| Pulmonary Associates, PA ( Site 0043) | Glendale | Arizona | 85306 | United States |
| Central Phoenix Medical Clinic, LLC ( Site 0031) | Phoenix | Arizona | 85020 | United States |
| Whiteriver Center for American Indian Health ( Site 0005) | Whiteriver | Arizona | 85941 | United States |
| Inland Empire Clinical Trials, LLC ( Site 0052) | Rialto | California | 92377 | United States |
| Top Medical Research, Inc ( Site 0033) | Cutler Bay | Florida | 33189 | United States |
| Indago Research & Health Center, Inc ( Site 0054) | Hialeah | Florida | 33012 | United States |
| Renstar Medical Research ( Site 0008) | Ocala | Florida | 34471 | United States |
| Triple O Research Institute, P.A. ( Site 0026) | West Palm Beach | Florida | 33407 | United States |
| Emory University School of Medicine at Grady Hospital ( Site 0027) | Atlanta | Georgia | 30303 | United States |
| Kootenai Health ( Site 0042) | Coeur d'Alene | Idaho | 83814 | United States |
| Evanston Premier Healthcare & Research, LLC. ( Site 0012) | Evanston | Illinois | 60201 | United States |
| Pharmakon Inc ( Site 0049) | Evergreen Park | Illinois | 60805 | United States |
| Reid Physician Associates ( Site 0055) | Richmond | Indiana | 47374 | United States |
| The Center for Pharmaceutical Research PC ( Site 0050) | Kansas City | Missouri | 64114 | United States |
| Clinical Research Consortium ( Site 0053) | Las Vegas | Nevada | 89119 | United States |
| Internal Medicine Associates [Bridgeton, NJ] ( Site 0015) | Bridgeton | New Jersey | 08302 | United States |
| Gallup Center for American Indian Health ( Site 0003) | Gallup | New Mexico | 87301 | United States |
| Shiprock Center for American Indian Health ( Site 0004) | Shiprock | New Mexico | 87420 | United States |
| Corning Center For Clinical Research ( Site 0036) | Corning | New York | 14830 | United States |
| Mid Hudson Medical Research ( Site 0022) | New Windsor | New York | 12553 | United States |
| Wake Research Associates, LLC ( Site 0016) | Raleigh | North Carolina | 27612 | United States |
| Lehigh Valley Health Network ( Site 0040) | Allentown | Pennsylvania | 18102 | United States |
| University of Pennsylvania ( Site 0030) | Philadelphia | Pennsylvania | 19104 | United States |
| Mountain View Clinical Research ( Site 0007) | Greer | South Carolina | 29651 | United States |
| Holston Medical Group ( Site 0025) | Kingsport | Tennessee | 37660 | United States |
| AIM Trials ( Site 0060) | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch at Galveston ( Site 0034) | Galveston | Texas | 77555-1115 | United States |
| Private Practice Leadership, LLC ( Site 0051) | Houston | Texas | 77094 | United States |
| Texas Center For Drug Development ( Site 0041) | Houston | Texas | 77801 | United States |
| Texas Institute Of Cardiology ( Site 0048) | McKinney | Texas | 75071 | United States |
| Village Health Partners ( Site 0006) | Plano | Texas | 75024 | United States |
| Copperview Medical Center ( Site 0038) | South Jordan | Utah | 84095 | United States |
| Timber Lane Allergy & Asthma Research, LLC ( Site 0044) | South Burlington | Vermont | 05403 | United States |
| Pulmonary & Sleep Research ( Site 0046) | Spokane Valley | Washington | 99216 | United States |
| Gundersen Health System ( Site 0021) | La Crosse | Wisconsin | 54601 | United States |
| Marshfield Clinic ( Site 0013) | Marshfield | Wisconsin | 54449 | United States |
| Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174) | Blacktown | New South Wales | 2148 | Australia |
| Holdsworth House Medical Practice ( Site 0170) | Sydney | New South Wales | 2010 | Australia |
| Core Research Group Pty limited ( Site 0175) | Brisbane | Queensland | 4064 | Australia |
| Emeritus Research Pty Ltd ( Site 0173) | Camberwell | Victoria | 3124 | Australia |
| Paratus Clinical Kanwal ( Site 0172) | Kanwal | 2259 | Australia |
| Nepean Hospital ( Site 0176) | Kingswood | 2747 | Australia |
| The Liver and Intestinal Research Centre (LAIR) ( Site 0302) | Vancouver | British Columbia | V5Z 1H2 | Canada |
| GA Research Associates, Ltd/Ltee ( Site 0303) | Moncton | New Brunswick | E1G 1A7 | Canada |
| Colchester Research Group ( Site 0094) | Truro | Nova Scotia | B2N 1L2 | Canada |
| Hamilton Medical Research Group ( Site 0092) | Hamilton | Ontario | L8M 1K7 | Canada |
| SKDS Research Inc. ( Site 0099) | Newmarket | Ontario | L3Y 5G8 | Canada |
| Omnispec Recherche Clinique Inc ( Site 0093) | Mirabel | Quebec | J7J 2K8 | Canada |
| Dynamik Research ( Site 0095) | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Diex Recherche Quebec Inc ( Site 0091) | Québec | Quebec | G1N 4V3 | Canada |
| Q & T Research Sherbrooke Inc. ( Site 0097) | Sherbrooke | Quebec | J1J 2G2 | Canada |
| Clinica Arauco Salud ( Site 0100) | Santiago | RM | 7560994 | Chile |
| Centro de Investigacion Clinica UC CICUC ( Site 0104) | Santiago | 8330034 | Chile |
| CECIM ( Site 0101) | Santiago | 8330336 | Chile |
| CESFAM Esmeralda ( Site 0102) | Santiago | 9351603 | Chile |
| Hospital Dr. Hernan Henriquez Aravena ( Site 0105) | Temuco | 4781151 | Chile |
| Southern Clinical Trials - Waitemata ( Site 0183) | Auckland | 0626 | New Zealand |
| Auckland Clinical Studies Limited ( Site 0189) | Auckland | 1010 | New Zealand |
| Optimal Clinical Trials ( Site 0182) | Auckland | 1010 | New Zealand |
| Christchurch Heart Institute ( Site 0280) | Christchurch | 8011 | New Zealand |
| Southern Clinical Trials Ltd ( Site 0180) | Christchurch | 8013 | New Zealand |
| Lakeland Clinical Trials ( Site 0181) | Rotorua | 3010 | New Zealand |
| Bay of Plenty Clinical School ( Site 0186) | Tauranga | 3143 | New Zealand |
| P3 Research Ltd - Wellington ( Site 0184) | Wellington | 6021 | New Zealand |
| WSOZ im.T.Browicza w Bydgoszczy ( Site 0317) | Bydgoszcz | 85-030 | Poland |
| Centrum Medyczne Pratia Bydgoszcz ( Site 0139) | Bydgoszcz | 85-796 | Poland |
| Synexus Polska Sp. z o.o. ( Site 0238) | Gdansk | 80-382 | Poland |
| Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233) | Krakow | 30-033 | Poland |
| ID Clinic ( Site 0235) | Mysłowice | 41-400 | Poland |
| Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319) | Skierniewice | 96-100 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314) | Sopot | 81-717 | Poland |
| Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236) | Wroclaw | 50-136 | Poland |
| Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234) | Wroclaw | 50-381 | Poland |
| Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249) | Kazan' | 420140 | Russia |
| Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144) | Saratov | 410054 | Russia |
| Smolensk State Medical University ( Site 0246) | Smolensk | 214019 | Russia |
Participants were to receive a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2).
| Vaccination 1 - (V114 or Prevnar 13â„¢, Day 1) |
|
| Vaccination 2 - (PNEUMOVAXâ„¢23, Month 6) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study vaccination.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V114 | Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). |
| BG001 | Prevnar 13â„¢ | Participants were to receive a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13â„¢ | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13â„¢, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson. | The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 5 days after Vaccination 1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13â„¢ | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following vaccination with V114 or Prevnar 13â„¢, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 days after Vaccination 1 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13â„¢ | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13â„¢, the percentage of serious adverse events of V114 compared with Prevnar 13â„¢ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Month 6 (before Vaccination 2) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13â„¢ | The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 |
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| Secondary | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAXâ„¢23 | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following Vaccination 2 with PNEUMOVAXâ„¢23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. | All randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 5 days after Vaccination 2 (Month 6) |
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| Secondary | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAXâ„¢23 | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAXâ„¢23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 days after Vaccination 2 (Month 6) |
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| Secondary | Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAXâ„¢23 | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAXâ„¢23, the percentage of serious adverse events of V114 compared with Prevnar 13â„¢ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. | The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Month 6 (before Vaccination 2) to Month 7 |
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| Secondary | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 30 |
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| Secondary | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Activity for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and Day 30 |
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| Secondary | GMFR in Serotype-specific IgG Day 1 to Day 30 | IgG for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and Day 30 |
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| Secondary | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (Baseline) and Day 30 |
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| Secondary | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (Baseline) and Day 30 |
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| Secondary | Geometric Mean Titer of Serotype-specific OPA at Month 7 | The geometric mean titer (GMT) of serotype-specific OPA for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Month 7 |
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| Secondary | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Month 7 |
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| Secondary | GMFR in Serotype-specific OPA Day 1 to Month 7 | Activity for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and Month 7 |
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| Secondary | GMFR in Serotype-specific IgG Day 1 to Month 7 | IgG for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and Month 7 |
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| Secondary | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (Baseline) and Month 7 |
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| Secondary | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (Baseline) and Month 7 |
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| Secondary | GMFR in Serotype-specific OPA Month 6 to Month 7 | Activity for the serotypes contained in Prevnar 13â„¢ and V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Month 6 (Baseline before Vaccination 2) and Month 7 |
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| Secondary | GMFR in Serotype-specific IgG Month 6 to Month 7 | IgG for the serotypes contained in Prevnar 13â„¢ and V114 and (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Month 6 (Baseline before Vaccination 2) and Month 7 |
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| Secondary | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 6 (Baseline before Vaccination 2) and Month 7 |
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| Secondary | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. | The analysis population included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 6 (Baseline before Vaccination 2) and Month 7 |
|
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Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 7 (Up to 44 days after vaccination 2).
The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13â„¢ group incorrectly received V114 and was included in the V114 group for safety analyses.
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 | V114 | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). | 4 | 1,134 | 49 | 1,134 | 934 | 1,134 |
| EG001 | Prevnar 13â„¢ | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). | 2 | 378 | 12 | 378 | 298 | 378 |
| EG002 | V114 (Post-PNEUMOVAXâ„¢23) | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). | 0 | 1,036 | 3 | 1,036 | 771 | 1,036 |
| EG003 | Prevnar 13â„¢ (Post-PNEUMOVAXâ„¢23) | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAXâ„¢23 at Month 6 (Vaccination 2). | 0 | 345 | 3 | 345 | 258 | 345 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiovascular insufficiency | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Diabetes insipidus | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Perirectal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Peritonsillitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| IIIrd nerve paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Drug dependence | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Physical assault | Social circumstances | MedDRA 23.0 | Systematic Assessment |
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| Hypertensive urgency | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Dec 14, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Injection site swelling |
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