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| ID | Type | Description | Link |
|---|---|---|---|
| V114-030 | Other Identifier | Merck | |
| 2019-000341-12 | EudraCT Number |
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This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13â„¢ followed 8 weeks later by a single dose of PNEUMOVAXâ„¢23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13â„¢ by each vaccination group. There are no formal hypotheses.
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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 Week 8 (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 Week 8 (Vaccination 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 | Biological | 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13â„¢ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13â„¢ | An adverse event (AE) is any untoward medical occurrence in a 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, hard lump/induration, tenderness/pain, and swelling. | Through 14 Days after Vaccination 1 (Up to Day 14) |
| Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13â„¢ | An AE is any untoward medical occurrence in a 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 systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. | Through 14 Days after Vaccination 1 (Up to Day 14) |
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13â„¢) or Vaccination 2 (PNEUMOVAXâ„¢23) Through Completion of Study | An SAE is an AE that results in death, 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 an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13â„¢) or Vaccination 2 (PNEUMOVAXâ„¢23) through completion of study participation was reported. | Through 6 Months after Vaccination 1 (Up to Day 194) |
| Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13â„¢ |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAXâ„¢23 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAXâ„¢23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perinatal HIV Research Unit ( Site 0042) | Johannesburg | Gauteng | 1864 | South Africa | ||
| Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36939067 | Result | Wilck M, Barnabas S, Chokephaibulkit K, Violari A, Kosalaraksa P, Yesypenko S, Chukhalova I, Dagan R, Richmond P, Mikviman E, Morgan L, Feemster K, Lupinacci R, Chiarappa J, Madhi SA, Bickham K, Musey L; V114-030 Study Group. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS. 2023 Jul 1;37(8):1227-1237. doi: 10.1097/QAD.0000000000003551. Epub 2023 Mar 17. |
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407 participants were randomized in a 1:1 ratio to receive either V114 or Prevnar 13â„¢ on Day 1 and PNEUMOVAXâ„¢23 at Week 8.
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 | 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 Week 8 (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 | Mar 27, 2019 |
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| Prevnar 13â„¢ | Biological | 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose. |
|
| PNEUMOVAXâ„¢23 | Biological | 23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose |
|
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. |
| Day 30 |
| Through 14 Days after Vaccination 2 (Up to Day 84) |
| Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAXâ„¢23 | An AE is any untoward medical occurrence in a 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 joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. | Through 14 Days after Vaccination 2 (Up to Day 84) |
| Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13â„¢ | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. | Day 30 |
| Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAXâ„¢23 (Week 12) | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. | Week 12 |
| Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAXâ„¢23 (Week 12) | The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. | Week 12 |
| Johannesburg |
| Gauteng |
| 2001 |
| South Africa |
| Family Clinic Research With UBUNTU ( Site 0045) | Cape Town | Western Cape | 7505 | South Africa |
| Be Part Yoluntu Centre ( Site 0041) | Paarl | Western Cape | 7626 | South Africa |
| Chulalongkorn University-Pediatrics ( Site 0062) | Bangkok | Bangkok | 10330 | Thailand |
| Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064) | Bangkok | Bangkok | 10700 | Thailand |
| Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063) | Amphoe Mueang | Changwat Khon Kaen | 40002 | Thailand |
| CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061) | Chiang Mai | 50200 | Thailand |
| Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088) | Dnipro | Dnipropetrovsk Oblast | 49006 | Ukraine |
| Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082) | Dnipro | Dnipropetrovsk Oblast | 49115 | Ukraine |
| Odesa Regional Center of Socially Significant Diseases ( Site 0083) | Odesa | Odesa Oblast | 65014 | Ukraine |
| Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086) | Vinnytsia | Vinnytsia Oblast | 21000 | Ukraine |
| Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089) | Zaporizhzhya | Zaporizhzhia Oblast | 69063 | Ukraine |
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 Week 8 (Vaccination 2).
| Vaccination 1 - (Day 1) |
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| Vaccination 2 - (Week 8) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V114 | 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 Week 8 (Vaccination 2). |
| BG001 | Prevnar 13â„¢ | 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 Week 8 (Vaccination 2). |
| 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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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13â„¢ | An adverse event (AE) is any untoward medical occurrence in a 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, hard lump/induration, tenderness/pain, and swelling. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 14 Days after Vaccination 1 (Up to Day 14) |
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| Primary | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13â„¢ | An AE is any untoward medical occurrence in a 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 systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 14 Days after Vaccination 1 (Up to Day 14) |
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| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13â„¢) or Vaccination 2 (PNEUMOVAXâ„¢23) Through Completion of Study | An SAE is an AE that results in death, 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 an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13â„¢) or Vaccination 2 (PNEUMOVAXâ„¢23) through completion of study participation was reported. | All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13â„¢ group did not receive PNEUMOVAXâ„¢23 and therefore were not analyzed for Vaccination 2. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 6 Months after Vaccination 1 (Up to Day 194) |
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| Primary | Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ | The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. | All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Day 30 |
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| Secondary | Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAXâ„¢23 | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAXâ„¢23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling. | All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13â„¢ group did not receive PNEUMOVAXâ„¢23 and therefore were not included in the analysis for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 14 Days after Vaccination 2 (Up to Day 84) |
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| Secondary | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAXâ„¢23 | An AE is any untoward medical occurrence in a 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 joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. | All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13â„¢ group did not receive PNEUMOVAXâ„¢23 and therefore were not included in the analysis for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Through 14 Days after Vaccination 2 (Up to Day 84) |
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| Secondary | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13â„¢ | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. | All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dil) | Day 30 |
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| Secondary | Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAXâ„¢23 (Week 12) | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13â„¢ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. | All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dil) | Week 12 |
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| Secondary | Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) | The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. | All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Week 12 |
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Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13â„¢ group did not receive PNEUMOVAXâ„¢23.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V114 | Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1). | 0 | 203 | 1 | 203 | 158 | 203 |
| EG001 | Prevnar 13â„¢ | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1). | 0 | 204 | 1 | 204 | 138 | 204 |
| 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 Week 8 (Vaccination 2). | 0 | 203 | 2 | 203 | 152 | 203 |
| EG003 | Prevnar 13â„¢ (Post-PNEUMOVAXâ„¢23) | 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 Week 8 (Vaccination 2). | 0 | 202 | 2 | 202 | 154 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serous retinal detachment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Nov 10, 2021 |
| 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 |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| Preterm newborn infants (gestational age < 37 wks) |
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| Newborns (0-27 days) |
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| Infants and toddlers (28 days-23 months) |
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| Children (2-11 years) |
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| Adolescents (12-17 years) |
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| Adults (18-64 years) |
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| From 65-84 years |
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| 85 years and over |
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| 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 tenderness/pain |
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| Injection site swelling |
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| Participants |
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| Units | Counts |
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