Pediatric Patients With Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
| NCT number | NCT01216332 |
| Other study ID # | VICC PED 1067 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | October 2010 |
| Est. completion date | May 2013 |
| Verified date | April 2019 |
| Source | Vanderbilt University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia. - Must be in 1st complete remission. - Must be 4 weeks into maintenance therapy. - 17 years of age, inclusive. - Available for duration of study. Exclusion Criteria: - History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein. - History of Guillain-Barre syndrome. - Evidence of relapsed disease. - Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol. - Have any condition that the investigator believes may interfere with successful completion of the study. - History of receiving 2010 - 2011 influenza vaccine. - Pregnant female. - History of proven influenza disease after September 1, 2010. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Vanderbilt University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Local Reactions After Each Vaccination | Number of participants with local reactions after each vaccination | From baseline to 7 days after each vaccination | |
| Primary | Systemic Reaction | Number of participants with systemic reactions after each vaccination | From baseline to 7 days after each vaccination | |
| 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) | About 6 months after last dose of vaccine. | |
| 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) | About 6 months after last dose of vaccine. | |
| 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) | About 6 months after last dose of vaccine. | |
| 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) | baseline | |
| 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) | About 6 months after last dose of vaccine. |