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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
Standard dose trivalent inactivated influenza vaccine
0.5 mL standard dose trivalent inactivated influenza vaccine

Locations

Country Name City State
United States Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

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.