Recruiting PHASE4 Influenza, Human

New treatment option for Influenza, Human

Official title Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults

ClinicalTrials.gov ID: NCT05108818

What this study is testing

What is Seasonal influenza vaccine?

Seasonal influenza vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for influenza, human.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Cellular and humoral immune responses before and after seasonal influenza vaccination will be assessed. Each year, up to 100 participants will be enrolled.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for all study visits
  • Aged 18 years and older
  • In good health based on self-reported medical conditions via an online survey

You likely can't join if

  • Known allergic reactions to components of the study vaccine
  • Known latex allergy
  • History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
  • History of GBS within 6 weeks of receipt of a previous influenza vaccine
  • Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or...
  • Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
See the full eligibility criteria
Who can join
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for all study visits
  • Aged 18 years and older
  • In good health based on self-reported medical conditions via an online survey
What rules you out
  • Known allergic reactions to components of the study vaccine
  • Known latex allergy
  • History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
  • History of GBS within 6 weeks of receipt of a previous influenza vaccine
  • Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
  • Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
  • Active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy ("active" is defined as having received treatment...
  • Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids
  • Administration of an influenza vaccine within 2 months prior to enrollment
  • Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses
  • Participation in a study that involves an experimental agent or having received an experimental agent (other than a COVID-19 vaccine) within 1 month prior to enrollment or expecting to receive another experimental agent...
  • Intends to donate blood during the study period
  • Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
  • Pregnancy
  • Known human immunodeficiency virus, hepatitis B, or hepatitis C infection
  • Any condition that the principal investigator believes may interfere with successful completion of the study

The study team makes the final eligibility decision.

Where it's taking place

  • Philadelphia, Pennsylvania, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.