Completed

Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Fluzone

Drug
Who is being recruted

From 18 to 50 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-ControlledEarly Phase 1
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorJohn Sundy
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).

Official TitleStrategies for Enhancing Mucosal Immunity to Influenza Vaccine
NCT01385215
Principal SponsorJohn Sundy
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Healthy men and women ages 18-50 years
Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use)
Willing and able to provide written informed consent
Able to speak and understand English
Show More Criteria
20 exclusion criteria prevent from participating
Influenza vaccination within 6 months prior to screening date
Symptoms of respiratory infection during the 14 days prior to screening
Temperature >38.3o C during the period spanning 72 hours prior to screening and the time of immunization.
History of allergy to egg, influenza vaccine or vaccine ingredients
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

100% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Placebo

Group III

Placebo

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Duke University Medical Center

Durham, United StatesOpen Duke University Medical Center in Google Maps
CompletedOne Study Center