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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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In this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered non-concomitantly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trivalent inactivated influenza vaccine | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 | ||
| TIV and PCV13 together | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | ||
| 13-valent pneumococcal conjugate vaccine | 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Fever >= 100.4 | 8 days |
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Inclusion Criteria:
(5) parent speaks English or Spanish.
Exclusion criteria:
Note: Patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)
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6-23 months old visiting study sites
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Stockwell, MD MPH | Columbia University | Principal Investigator |
| Philip LaRussa, MD | Columbia University | Principal Investigator |
| Karen Broder, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States | ||
| Columbia University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24395025 | Derived | Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trivalent Inactivated Influenza Vaccine (TIV) Alone | Trivalent inactivated influenza vaccine 0.25ml IM X 1 |
| FG001 | TIV and PCV13 Together | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 |
| FG002 | 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone | 13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trivalent Inactivated Influenza Vaccine (TIV) Alone | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 |
| BG001 | TIV and PCV13 Together | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Fever >= 100.4 | Participants in analysis included those for whom both day 0 and day 1 temperature data was reported. | Posted | Number | percentage of participants | 8 days |
|
7 days
medical record review
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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 | Trivalent Inactivated Influenza Vaccine (TIV) Alone | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Stockwell | Columbia University | 212-342-5732 | mss2112@columbia.edu |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| New York |
| New York |
| 10032 |
| United States |
| BG002 | 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone | 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 |
|
|
| 0 |
| 208 |
| 0 |
| 208 |
| EG001 | TIV and PCV13 Together | Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | 0 | 212 | 0 | 212 |
| EG002 | 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone | 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | 0 | 110 | 0 | 110 |
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