InfluenzaNCT05436184
Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
An observational study of Influenza, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We will seek to obtain a balanced temporal distribution of the cohort births to account for seasonal variations in influenza transmission patterns. We will seek to enroll 30 eligible women per month by posting advertisements via study flyers and brochures in the maternal clinics, social media, institutional wide emails, and each of the enrollment clinic sites. Our staff will screen pregnant women in clinic settings for inclusion/exclusion criteria and then consent and enroll those eligible to participate.
Who may be able to join
- Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age
- Plans to deliver at local hospital
- Lives within designated home zip codes:
- No plans to move outside study area within study timeframe
- Cell phone that can be used for text messaging
- Singleton live born infant, born ≥ 34 weeks gestational age (GA)
Who cannot join
- Fetal or infant death prior to maternal hospital discharge
- Mother known to be infected with HIV based on medical records
- Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI
- Reported use of heroin, cocaine or methamphetamines during pregnancy
- Adoptive infant
- Enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the PI's deem to be in conflict with study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45219
About this study
The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures
Read the detailed description
Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.
- Conditions
- Influenza
- Keywords
- influenza, birth cohort
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cincinnati IMPRINT birth cohort | mother-infant pairs enrolled at or after week 34 in pregnancy and followed over three flu seasons, up to four years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to influenza virus infection
Evaluate the immune response to influenza virus infections due to various subtypes in healthy children from birth to 4 years of age in a maternal-infant birth cohort
Measured: 4 years
Immune response to influenza vaccination
Evaluate the immune response to influenza vaccination in healthy children from 6 months to 4 years of age in a maternal-infant birth cohort
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start17 Oct 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Staat, MD,MPH, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436184
- Sponsor's protocol ID
- 1U01AI144673-01
- Other IDs
- 1U01AI144673-01
- Status last verified
- Nov 2025
- First submitted
- 23 Jun 2022
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants
- ClinicalTrials.gov ID
- NCT05436184
- Acronym / sponsor ID
- 1U01AI144673-01
- Conditions
- Influenza
- Keywords
- influenza, birth cohort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures
Detailed description
Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cincinnati IMPRINT birth cohort | – | –mother-infant pairs enrolled at or after week 34 in pregnancy and followed over three flu seasons, up to four years of age. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will seek to obtain a balanced temporal distribution of the cohort births to account for seasonal variations in influenza transmission patterns. We will seek to enroll 30 eligible women per month by posting advertisements via study flyers and brochures in the maternal clinics, social media, institutional wide emails, and each of the enrollment clinic sites. Our staff will screen pregnant women in clinic settings for inclusion/exclusion criteria and then consent and enroll those eligible to participate.
Key inclusion criteria (6 listed)
- Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age
- Plans to deliver at local hospital
- Lives within designated home zip codes:
- No plans to move outside study area within study timeframe
- Cell phone that can be used for text messaging
Key exclusion criteria (6 listed)
- Fetal or infant death prior to maternal hospital discharge
- Mother known to be infected with HIV based on medical records
- Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI
- Reported use of heroin, cocaine or methamphetamines during pregnancy
- Adoptive infant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune response to influenza virus infection
Time frame: 4 years
Evaluate the immune response to influenza virus infections due to various subtypes in healthy children from birth to 4 years of age in a maternal-infant birth cohort
Immune response to influenza vaccination
Time frame: 4 years
Evaluate the immune response to influenza vaccination in healthy children from 6 months to 4 years of age in a maternal-infant birth cohort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- 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.
Mary Staat, MD,MPH principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Children's Hospital Medical Center, Cincinnati 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Immune response to influenza virus infection (time frame: 4 years). The study lists 2 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 5 Nov 2025.