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| ID | Type | Description | Link |
|---|---|---|---|
| 200 2012 53663 0009 | Other Grant/Funding Number | CDC |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Kaiser Permanente | OTHER |
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A prospective, randomized open-label clinical trial that will be conducted during the 2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be enrolled at Duke University Medical Center and Kaiser Permanente Northern California. Eligible children will be randomized to receive simultaneous or sequentially administered US licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit 1, and then return for a health education visit without vaccination about 2 weeks later (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2). Parents will record the occurrence of fever, solicited adverse events, medical care utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2. In addition, febrile seizures and serious adverse events will be recorded for the entire study period (from enrollment through 8 days following the Visit 2) as determined through parental report and chart review. Parental perceptions about their child's vaccine schedule will be assessed on the 8th day following Visit 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous vaccination arm | Other | In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2. |
|
| Sequential vaccination arm | Other | In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV13 | Biological | ACIP Recommended vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fever Following Vaccination | Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2. | 2 days post administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fever Visit 1 | Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 | 2 days post administration |
| Number of Participants With Fever Visit 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel B Walter, MD, MPH | Duke University | Principal Investigator |
| Karen Broder, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Nicola Klein, MD, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Oakland | California | 94612 | United States | ||
| Centers for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32029684 | Derived | Walter EB, Klein NP, Wodi AP, Rountree W, Todd CA, Wiesner A, Duffy J, Marquez PL, Broder KR. Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations. Pediatrics. 2020 Mar;145(3):e20191909. doi: 10.1542/peds.2019-1909. Epub 2020 Feb 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Simultaneous Vaccination Arm | In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2. PCV13: ACIP Recommended vaccine DTaP: ACIP Recommended vaccine IIV: ACIP Recommended vaccine |
| FG001 | Sequential Vaccination Arm | In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2. PCV13: ACIP Recommended vaccine DTaP: ACIP Recommended vaccine IIV: ACIP Recommended vaccine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per Protocol Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Simultaneous Vaccination Arm | In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2. PCV13: ACIP Recommended vaccine DTaP: ACIP Recommended vaccine IIV: ACIP Recommended vaccine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Fever Following Vaccination | Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2. | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
Adverse events were collected through 8 days post Visit 2.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 1% (febrile seizure only) were collected and reported. Per protocol, the only AE collected was febrile seizure.
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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 | Simultaneous Vaccination Arm | In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2. PCV13: ACIP Recommended vaccine DTaP: ACIP Recommended vaccine IIV: ACIP Recommended vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | General disorders | Systematic Assessment | Subject presented with fever, upper respiratory symptoms, decreased oral intake and dehydration 13 days after Visit 1. The SAE was considered unrelated to vaccination by the investigator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emmanuel B. Walter | Duke University | 919-620-5346 | chip.walter@duke.edu |
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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 2, 2018 | Dec 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| D003294 | Seizures, Febrile |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012640 | Seizures |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| DTaP | Biological | ACIP Recommended vaccine |
|
|
| IIV | Biological | ACIP Recommended vaccine |
|
|
Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2
| 2 days post administration |
| Number of Participants With Grade 2 and/or 3 Fever Following Visit 1 | Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.6°C or ≥ 101.4°F) | 2 days post administration |
| Number of Participants With Grade 2 and/or 3 Fever Following Visit 2 | Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. | 2 days post administration |
| Number of Participants With Grade 2 and/or 3 Following Visit 1 and Visit 2 | Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. | 2 days post administration |
| Duration of Fever - Visit 1 | Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 1. Note: fever starting on day 1 or 2 could continue through day 8. | 8 days post administration |
| Duration of Fever - Visit 2 | Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 2. Note: fever starting on day 1 or 2 could continue through day 8. | 8 days post administration |
| Duration of Fever - Visit 1 and 2 Combined | Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 1 and Visit 2 combined. Note: fever starting on day 1 or 2 could continue through day 8. | 8 days post administration |
| Number of Participants With Medical Care Utilization - Visit 1 | Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1. | 2 days post administration |
| Number of Participants With Medical Care Utilization - Visit 2 | Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 2. | 2 days post administration |
| Number of Participants With Medical Care Utilization - Visit 1 and 2 Combined | Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1 and Visit 2 combined. | 2 days post administration |
| Atlanta |
| Georgia |
| 30333 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Sequential Vaccination Arm |
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2. PCV13: ACIP Recommended vaccine DTaP: ACIP Recommended vaccine IIV: ACIP Recommended vaccine |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance | Count of Participants | Participants |
|
| Number of Children Living in Home | Median | Full Range | Children |
|
| Day Care | Count of Participants | Participants |
|
| Gestational Age in Weeks | Median | Full Range | Weeks |
|
| Birth Weight in Pounds | Median | Full Range | Pounds |
|
| Receipt of 1st or Only Dose of Influenza Vaccine for the Season | Count of Participants | Participants |
|
| Receipt of 2nd Dose of Influenza Vaccine for the Season | Count of Participants | Participants |
|
| Receipt of Concomitant Vaccine | Count of Participants | Participants |
|
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
PCV13: ACIP Recommended vaccine
DTaP: ACIP Recommended vaccine
IIV: ACIP Recommended vaccine
|
|
|
| Secondary | Number of Participants With Fever Visit 1 | Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
|
| Secondary | Number of Participants With Fever Visit 2 | Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2 | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
|
| Secondary | Number of Participants With Grade 2 and/or 3 Fever Following Visit 1 | Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.6°C or ≥ 101.4°F) | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
|
| Secondary | Number of Participants With Grade 2 and/or 3 Fever Following Visit 2 | Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
|
| Secondary | Number of Participants With Grade 2 and/or 3 Following Visit 1 and Visit 2 | Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
|
| Secondary | Duration of Fever - Visit 1 | Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 1. Note: fever starting on day 1 or 2 could continue through day 8. | Per Protocol Population | Posted | Mean | Full Range | Fever Days | 8 days post administration |
|
|
|
|
| Secondary | Duration of Fever - Visit 2 | Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 2. Note: fever starting on day 1 or 2 could continue through day 8. | Per Protocol Population | Posted | Mean | Full Range | Fever Days | 8 days post administration |
|
|
|
| Secondary | Duration of Fever - Visit 1 and 2 Combined | Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 1 and Visit 2 combined. Note: fever starting on day 1 or 2 could continue through day 8. | Per Protocol Population | Posted | Mean | Full Range | Fever Days | 8 days post administration |
|
|
|
|
| Secondary | Number of Participants With Medical Care Utilization - Visit 1 | Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1. | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
| Secondary | Number of Participants With Medical Care Utilization - Visit 2 | Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 2. | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
| Secondary | Number of Participants With Medical Care Utilization - Visit 1 and 2 Combined | Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1 and Visit 2 combined. | Per Protocol Population | Posted | Count of Participants | Participants | 2 days post administration |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Sequential Vaccination Arm | In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2. PCV13: ACIP Recommended vaccine DTaP: ACIP Recommended vaccine IIV: ACIP Recommended vaccine | 0 | 107 | 1 | 107 | 0 | 107 |
|
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014765 | Viral Vaccines |