Half-Dose Flu Vaccine Study in Healthy Adults

Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006146

Enrollment

840

Registered

2001-08-31

Start date

2000-08-31

Completion date

2000-09-30

Last updated

2010-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

BIOLOGICALApproved influenza virus vaccine.

Study design

Primary purpose

PREVENTION

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026