- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328325
Age and Response to Flu Vaccines
April 29, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Evaluation of the Effects of Age, Prior Exposure, and Previous Vaccination on the B Cell Response to Inactivated Influenza Vaccine in Healthy Adults and Children
The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over.
Study duration will be 5 years, with a participant duration of 6 months.
Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90.
The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over.
Study duration will be 5 years, with a participant duration of 6 months.
Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90.
The primary hypothesis being tested in this study is that there will be differences in the specificity and magnitude of the HA-specific B cell response depending on the age, previous vaccine history and baseline B cell reactivity.
The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.
The secondary objective is to evaluate factors related to failure of vaccine to provide protection against symptomatic influenza and the immune response to infection in vaccinated individuals by prospective surveillance of the vaccine cohort.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14642-0001
- University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
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Rochester, New York, United States, 14621-3001
- Rochester General Hospital - Infectious Disease Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 99 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged equal to or greater than 9 years of age and weigh at least 50 pounds
- The subject must be in good health, as determined by: medical history; and targeted physical examination, when necessary, based on medical history. Stable medical or psychiatric condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months
- The subject is able to understand and comply with the planned study procedures, including being available for all study visits
- The subject/parent has provided informed consent/assent prior to any study procedures
- Subjects who have not received seasonal flu vaccine for the current year
Exclusion Criteria:
- Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine
- Subject report of known latex allergy
- Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
- Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine
- The subject is a female of childbearing potential who is currently pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 90 days following receipt of vaccine. Pregnancy will be determined by subject interview. Pregnancy testing is not done in this study since there is no increased risk in pregnancy
- The subject is immunosuppressed 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
- The subject has an 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. For this criterion, "active" is defined as having received treatment within the past 5 years
- Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-reference-html#estimated-comparative-daily-doses
- The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study
- The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days after vaccination
- The subject has an 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. These conditions include any acute or chronic medical disease or conditions defined as persisting for 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study
- Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved > 3 days prior to enrollment
- The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period
- The subject has 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
- The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment
- The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection
- Subject weighs less than 50 lbs
- Subject expects to have a medical procedure during the upcoming 8 weeks that estimates blood loss to exceed 400 cc for adults or for children would exceed 3 ml/kg
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240
|
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time Frame: Through Day 28
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A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
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Through Day 28
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Magnitude of the Serum Antibody Response by Microneutralization (MN)
Time Frame: Day 28
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A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018
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Day 28
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Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time Frame: Day 90
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A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018
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Day 90
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Serum Antibody Response by Microneutralization (MN)
Time Frame: Day 90
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A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018
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Day 90
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Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time Frame: Day 28
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A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018
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Day 28
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Specificity of the Serum Antibody Response by Microneutralization (MN)
Time Frame: Day 28
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A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18
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Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age at Time of First Influenza A Exposure
Time Frame: Baseline
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Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
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Baseline
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Baseline B Cell Reactivity
Time Frame: Baseline
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Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
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Baseline
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Vaccine History (Number and Percentage of Participants to Receive Vaccine)
Time Frame: Baseline
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Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2017
Primary Completion (Actual)
February 9, 2020
Study Completion (Actual)
April 20, 2020
Study Registration Dates
First Submitted
October 26, 2017
First Submitted That Met QC Criteria
October 26, 2017
First Posted (Actual)
November 1, 2017
Study Record Updates
Last Update Posted (Actual)
May 24, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
March 3, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-0101
- HHSN272201400005C
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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