Half-Dose Flu Vaccine Study in Healthy Adults

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA Center for Vaccine Research, Torrance, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Approved influenza virus vaccine.

Biological

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start: 2000
Study completion: 2000
First posted: Aug 31, 2001
Registry last updated: Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed