InfluenzaPhase 4NCT03328325
Age and Response to Flu Vaccines
A Phase 4 study testing Influenza Virus Quadrivalent Inactivated Vaccine in people with Influenza and Influenza Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Immunisation
- What is being tested?
- Influenza Virus Quadrivalent Inactivated Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Dec 2017to 20 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rochester General Hospital - Infectious Disease Unit
Rochester, New York, 14621-3001
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza, Influenza Immunisation
- Being tested
- Influenza Virus Quadrivalent Inactivated Vaccine
- Keywords
- B Cell Response, Children, Evaluation, Healthy Adults, Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus Quadrivalent Inactivated VaccineBiological
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.
Influenza Virus Quadrivalent Inactivated VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240 Receives: Biological: Influenza Virus Quadrivalent Inactivated Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
Measured: Through Day 28
Magnitude of the Serum Antibody Response by Microneutralization (MN)
A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018
Measured: Day 28
Serum Antibody Response by Hemagglutination-inhibition (HAI)
A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018
Measured: Day 90
Serum Antibody Response by Microneutralization (MN)
A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018
Measured: Day 90
Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018
Measured: Day 28
Specificity of the Serum Antibody Response by Microneutralization (MN)
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18
Measured: Day 28
Secondary outcomes (8)
Age Group Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Measured: Baseline
Sex Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Measured: Baseline
Ethnicity Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Measured: Baseline
Race Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not
Measured: Baseline
Immune Response to the H1N1/Michigan/45/2015H1N1)pdm09 by Hemagglutination-inhibition (HAI) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an HAI immune response to the H1N1/Michigan/45/2015H1N1)pdm09 antigen.
Measured: Day 28 and Day 90
Immune Response to the A/Hong Kong/4801/2014 (H3N2) by Hemagglutination-inhibition (HAI) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an HAI immune response to the A/Hong Kong/4801/2014 (H3N2) antigen.
Measured: Day 28 and Day 90
Immune Response to the H1N1/Michigan/45/2015H1N1)pdm09 by Microneutralization (MN) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an MN immune response to the H1N1/Michigan/45/2015H1N1)pdm09 antigen.
Measured: Day 28 and Day 90
Immune Response to the A/Hong Kong/4801/2014 (H3N2) by Microneutralization (MN) to Vaccination Stratified by Influenza Infection Status
Comparison between groups: subjects who develop symptomatic influenza (Vaccine Failures) vs. subjects who do not. This is an MN immune response to the A/Hong Kong/4801/2014 (H3N2) antigen.
Measured: Day 28 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start14 Dec 2017
- Primary completion9 Feb 2020
- Study completion20 Apr 2020
Why it stopped: Study visits could not be completed for all enrolled participants due to COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328325
- Sponsor's protocol ID
- 16-0101
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2017
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03328325
- Acronym / sponsor ID
- 16-0101
- Conditions
- Influenza, Influenza Immunisation
- Keywords
- B Cell Response, Children, Evaluation, Healthy Adults, Influenza Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study visits could not be completed for all enrolled participants due to COVID-19 Pandemic
- Enrolment
- 152 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: Influenza Virus Quadrivalent Inactivated Vaccine0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240 |
Who may qualify
- Ages
- 9 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Virus Quadrivalent Inactivated VaccineA 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. | Biological | Arm 1 |
| Influenza Virus Quadrivalent Inactivated VaccineA 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. | Biological | Arm 1 |
Primary outcome
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time frame: Through Day 28
A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
Magnitude of the Serum Antibody Response by Microneutralization (MN)
Time frame: Day 28
A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018
Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time frame: Day 90
A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018
Serum Antibody Response by Microneutralization (MN)
Time frame: Day 90
A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018
Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time frame: Day 28
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018
Specificity of the Serum Antibody Response by Microneutralization (MN)
Time frame: Day 28
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18
8 secondary outcomes
Age Group Stratified by Influenza Infection Status
Time frame: Baseline
Sex Stratified by Influenza Infection Status
Time frame: Baseline
Ethnicity Stratified by Influenza Infection Status
Time frame: Baseline
Race Stratified by Influenza Infection Status
Time frame: Baseline
Immune Response to the H1N1/Michigan/45/2015H1N1)pdm09 by Hemagglutination-inhibition (HAI) to Vaccination Stratified by Influenza Infection Status
Time frame: Day 28 and Day 90
Immune Response to the A/Hong Kong/4801/2014 (H3N2) by Hemagglutination-inhibition (HAI) to Vaccination Stratified by Influenza Infection Status
Time frame: Day 28 and Day 90
Immune Response to the H1N1/Michigan/45/2015H1N1)pdm09 by Microneutralization (MN) to Vaccination Stratified by Influenza Infection Status
Time frame: Day 28 and Day 90
Immune Response to the A/Hong Kong/4801/2014 (H3N2) by Microneutralization (MN) to Vaccination Stratified by Influenza Infection Status
Time frame: Day 28 and Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Virus Quadrivalent Inactivated Vaccine in people with Influenza and Influenza Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI) (time frame: Through Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.