Clinical trial NCT00006146: Half-Dose Flu Vaccine Study in Healthy Adults
Official title: Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose. This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.

If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose, this could be a strategy to extend the amount of vaccine that could be available in this age group.

Detailed description: Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination. A second blood draw will be done.

Eligibility criteria: Inclusion Criteria:

Volunteers may be eligible for this trial if they:

* Are able to and have given informed consent.
* Are able to understand and comply with all study procedures and to complete study diary.
* Are aged 18 to 49 years.
* Are female, and are not pregnant.
* Are available for all study visits.

Exclusion Criteria:

Volunteers will not be eligible for this trial if they:

* Are allergic to eggs or egg products.
* Have a current chronic medical condition for which influenza vaccine is normally recommended.
* Have received experimental vaccines or medications within 30 days of study entry.
* Have received parenteral immunoglobulin within 30 days of study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: UCLA Center for Vaccine Research
state: California
city: College Park
country: United States
facility: Maryland CARES
state: Maryland
city: St Louis
country: United States
facility: Center for Vaccine Development
state: Missouri
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Inf Dis Clinic at Gamble Research Clinic and Bethesda Hosp
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Univ of Rochester Medical Center
name: John Treanor
role: PRINCIPAL_INVESTIGATOR
References: