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This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose trivalent inactivated influenza vaccine | Experimental | 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. |
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| Standard dose trivalent inactivated influenza vaccine | Active Comparator | 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose trivalent inactivated influenza vaccine | Drug | 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Reactions After Each Vaccination | Number of participants with local reactions after each vaccination | From baseline to 7 days after each vaccination |
| Systemic Reaction | Number of participants with systemic reactions after each vaccination | From baseline to 7 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise | Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | About 6 months after last dose of vaccine. |
| Immunogenicity:Number of Participants With a Pre-titer ≥1:40 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Halasa, M.D. | Vanderbilt Universtiy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
Four subjects (from the high dose group) were excluded from the data analysis , because they were given the second dose of TIV outside the study window period. These four subjects were included in the adverse event reporting.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose Trivalent Inactivated Influenza Vaccine | 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. |
| FG001 | Standard Dose Trivalent Inactivated Influenza Vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard dose trivalent inactivated influenza vaccine | Drug | 0.5 mL standard dose trivalent inactivated influenza vaccine |
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Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) |
| About 6 months after last dose of vaccine. |
| Immunogenicity: Number of Participants With a Post-titer ≥1:40 | Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | About 6 months after last dose of vaccine. |
| Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants | Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | baseline |
| Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants | Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | About 6 months after last dose of vaccine. |
0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine |
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| NOT COMPLETED |
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Four subjects were excluded from the data analysis (from the high dose group), because they were given the second dose of TIV outside the study window period
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose Trivalent Inactivated Influenza Vaccine | 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. High-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. |
| BG001 | Standard Dose Trivalent Inactivated Influenza Vaccine | 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine Standard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | ||||||||||||||||||||||||||||||
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| Primary | Local Reactions After Each Vaccination | Number of participants with local reactions after each vaccination | Posted | Count of Participants | Participants | From baseline to 7 days after each vaccination |
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| Primary | Systemic Reaction | Number of participants with systemic reactions after each vaccination | Posted | Count of Participants | Participants | From baseline to 7 days after each vaccination |
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| Secondary | Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise | Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data | Posted | Count of Participants | Participants | About 6 months after last dose of vaccine. |
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| Secondary | Immunogenicity:Number of Participants With a Pre-titer ≥1:40 | Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data | Posted | Count of Participants | Participants | About 6 months after last dose of vaccine. |
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| Secondary | Immunogenicity: Number of Participants With a Post-titer ≥1:40 | Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data | Posted | Count of Participants | Participants | About 6 months after last dose of vaccine. |
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| Secondary | Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants | Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titers | baseline |
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| Secondary | Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants | Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008) | Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titers | About 6 months after last dose of vaccine. |
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AEs were collected for 28 days after last vaccination, and SAEs were collected through 180 days after their final vaccination via phone call and medical chart 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 | High-Dose Trivalent Inactivated Influenza Vaccine | 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. High-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. | 0 | 34 | 9 | 34 | 21 | 34 |
| EG001 | Standard Dose Trivalent Inactivated Influenza Vaccine | 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine Standard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine | 0 | 16 | 6 | 16 | 14 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Otitis Media | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Influenza B | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Fever | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Coronavirus | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Viral Illness | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| New Onset Seizures | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness at injection site | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Pain at Injection Site | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Tenderness | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Intense Swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Decrease in Activity | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Fever | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Body Aches | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natasha Halasa | Vanderbilt | 6153223346 | natasha.halasa@vanderbilt.edu |
| >=65 years |
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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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| Intense Swelling |
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| Redness |
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