InfluenzaPhase 1FLU-PGNCT03888989
Response to Influenza Vaccine During Pregnancy
A Phase 1 study testing Quadrivalent inactivated influenza vaccine (IIV) in people with Influenza, run by Stanford University at 1 site in United States.
Trial summary
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent inactivated influenza vaccine (IIV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 31 Dec 2023
- Phase
- Phase 1
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-49-year-old pregnant woman
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study with the expected delivery date more than 28 days after vaccination
- Acceptable medical history by review of inclusion/exclusion criteria
Who cannot join
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, or arginine.
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
- Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
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- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
- Receipt of blood or blood products within the past 6 months or planned used during the study.
- A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination)
- Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment)
- Need for allergy immunization (that cannot be postponed) until after the last study visit.
- History of Guillain-Barre# syndrome
- Use of investigational agents within 30 days prior to enrollment or planned use during the study.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy.
Read the detailed description
This is a Phase I mechanistic study of licensed influenza vaccines with up to 50 pregnant female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant women and then from the same women a year later when they are not pregnant after routine seasonal influenza vaccination. By studying the blood of immunized pregnant women and in these same women after pregnancy, the investigator will gain a better understanding of the immune response to vaccination in pregnancy and after pregnancy.
Each volunteer will participate for approximately 4 weeks including enrollment, vaccination, and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6 visits over 2 Flu seasons.
Study procedures:
Year One:
First Visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination.
2nd and 3rd visits: 20 ml blood will be obtained
Year Two:
First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained
- Conditions
- Influenza
- Being tested
- Quadrivalent inactivated influenza vaccine (IIV)
- Keywords
- Influenza, Pregnancy, Quadrivalent inactivated influenza vaccine (IIV).
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent inactivated influenza vaccine (IIV)Biological
Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Study Phase | Other | Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV) Receives: Biological: Quadrivalent inactivated influenza vaccine (IIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HAI Titer at Day 7 (Year 1)
HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Measured: Day 7 (after year 1 vaccine administration)
Number of Participants With Related Adverse Events (Year 1)
AEs related to IIV
Measured: Baseline to Day 28 post year 1 vaccine administration
Number of Participants With Related Adverse Events (Year 2)
AEs to IIV
Measured: Baseline to Day 28 post year 2 vaccine administration
Plasma HAI Titer at Day 7 (Year 2)
HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Measured: Day 7 (Year 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start30 Sep 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Enrollment was not complete given logistical concerns that arose during the 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 Stanford UniversityThe 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Philip Grant, Stanford University
- Investigators
- Philip M Grant, Principal investigator, Assistant Professor of Medicine (Infectious Diseases)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888989
- Sponsor's protocol ID
- 50163
- Other IDs
- 5U19AI057229-15
- Acronym
- FLU-PG
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2019
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Influenza Vaccine During Pregnancy
- ClinicalTrials.gov ID
- NCT03888989
- Acronym / sponsor ID
- FLU-PG / 50163
- Conditions
- Influenza
- Keywords
- Influenza, Pregnancy, Quadrivalent inactivated influenza vaccine (IIV).
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was not complete given logistical concerns that arose during the COVID-19 pandemic
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy.
Detailed description
This is a Phase I mechanistic study of licensed influenza vaccines with up to 50 pregnant female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant women and then from the same women a year later when they are not pregnant after routine seasonal influenza vaccination. By studying the blood of immunized pregnant women and in these same women after pregnancy, the investigator will gain a better understanding of the immune response to vaccination in pregnancy and after pregnancy.
Each volunteer will participate for approximately 4 weeks including enrollment, vaccination, and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6 visits over 2 Flu seasons.
Study procedures:
Year One:
First Visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination.
2nd and 3rd visits: 20 ml blood will be obtained
Year Two:
First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Phase | Other | Biological: Quadrivalent inactivated influenza vaccine (IIV)Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-49-year-old pregnant woman
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study with the expected delivery date more than 28 days after vaccination
- Acceptable medical history by review of inclusion/exclusion criteria
Key exclusion criteria (21 listed)
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, or arginine.
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
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 |
|---|---|---|
| Quadrivalent inactivated influenza vaccine (IIV)Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection | Biological | Study Phase |
Primary outcome
Plasma HAI Titer at Day 7 (Year 1)
Time frame: Day 7 (after year 1 vaccine administration)
HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Number of Participants With Related Adverse Events (Year 1)
Time frame: Baseline to Day 28 post year 1 vaccine administration
AEs related to IIV
Number of Participants With Related Adverse Events (Year 2)
Time frame: Baseline to Day 28 post year 2 vaccine administration
AEs to IIV
Plasma HAI Titer at Day 7 (Year 2)
Time frame: Day 7 (Year 2)
HAI titer measures immune response to influenza vaccination. An HAI titer is a hemoglobin assay that correlates to protection from influenza infection; an HAI titer of 40 or greater is considered to be protective.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Philip M Grant principal investigator
Assistant Professor of Medicine (Infectious Diseases)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quadrivalent inactivated influenza vaccine (IIV) in people with Influenza, run by Stanford University at 1 site 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 4 inclusion and 21 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Feb 2025). 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?
Plasma HAI Titer at Day 7 (Year 1) (time frame: Day 7 (after year 1 vaccine administration)). The study lists 4 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 17 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.