PregnancyNCT02148874

Immune Responses to the Flu Shot During Pregnancy

An observational study of Pregnancy, run by Lisa Christian at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy
What is being tested?: influenza virus vaccination
Type of treatment: Vaccines
How many people: 287 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Aug 2019
Phase: Observational
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 42 years
Women only
Healthy volunteers accepted
Adult

Study population: community sample, prenatal clinic

Who may be able to join

less than 29 weeks pregnant
ages 18-42
planning to deliver at The Ohio State University Wexner Medical Center

Who cannot join

prior serious adverse reaction to seasonal influenza vaccine

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43220

Other trials in United States

About this study

This study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody levels against influenza (the flu) increase. Higher antibody levels indicate better immune protection from influenza. In addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. Our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.

Conditions: Pregnancy
Being tested: influenza virus vaccination
Keywords: pregnant, flu shot, 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 vaccinationBiological
Also called flu shot, influenza shot, flu vaccine
comparison of immune responses to the flu vaccine in obese and non-obese populations

Study groups in NCT02148874
Study group	Role	What they receive
Flu Shot		pregnant women receive a seasonal influenza virus vaccination Receives: Biological: influenza virus vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal HAI Antibody Titers
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
Measured: 30-days after influenza vaccination
Maternal HAI Antibody Titers
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
Measured: at delivery

Secondary outcomes (1)

Infant HAI Antibody Titers
Infant influenza antibody titers from hemagglutination inhibition (HAI) assay
Measured: cord blood at delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Aug 2019

First posted28 May 2014 (estimated)
Study startOct 2013
Primary completionMay 2017
Study completionAug 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PregnancyStudies of the same condition, open and under way.
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: Case-control
Time perspective: Prospective
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02148874
Sponsor's protocol ID: 2008H0260
Status last verified: Sep 2019
First submitted: 23 May 2014
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Christian LM, Beverly C, Mitchell AM, Karlsson E, Porter K, Schultz-Cherry S, Ramilo O. Effects of prior influenza virus vaccination on maternal antibody responses: Implications for achieving protection in the newborns. Vaccine. 2017 Sep 18;35(39):5283-5290. doi: 10.1016/j.vaccine.2017.05.050. Epub 2017 Aug 1.
PubMed 28778612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immune Responses to the Flu Shot During Pregnancy
ClinicalTrials.gov ID: NCT02148874
Acronym / sponsor ID: 2008H0260
Conditions: Pregnancy
Keywords: pregnant, flu shot, influenza, vaccine
Study type: Observational
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: Lisa ChristianUniversity, hospital or other
Study start: Oct 2013
Primary completion: May 2017 (actual)
Study completion: Aug 2019 (actual)
First posted: 28 May 2014 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Flu Shot	–	Biological: influenza virus vaccinationpregnant women receive a seasonal influenza virus vaccination

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: community sample, prenatal clinic

Key inclusion criteria (3 listed)

less than 29 weeks pregnant
ages 18-42
planning to deliver at The Ohio State University Wexner Medical Center

Key exclusion criteria (1 listed)

prior serious adverse reaction to seasonal influenza vaccine

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 vaccinationAlso: flu shot, influenza shot, flu vaccinecomparison of immune responses to the flu vaccine in obese and non-obese populations	Biological	Flu Shot

Primary outcome

Maternal HAI Antibody Titers
Time frame: 30-days after influenza vaccination
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay
Maternal HAI Antibody Titers
Time frame: at delivery
Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

1 secondary outcome

Infant HAI Antibody Titers
Time frame: cord blood at delivery

Results and safety

Results posted to the registry on 28 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Obese	201	194
Obese	86	84

Primary outcome: Maternal HAI Antibody Titers

Time frame: 30-days after influenza vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Non-Obese n = 188	Obese n = 75
A/H1N1 Strain	55.9 (43.0 to 72.5)	59.8 (41.1 to 87.0)
A/H3N2 Strain	78.5 (60.9 to 101.1)	74.0 (48.9 to 112.1)
B/Massachusetts Strain	17.3 (13.9 to 21.6)	22.3 (15.2 to 32.8)
B/Brisbane Strain	17.8 (14.4 to 22.1)	20.8 (14.1 to 30.6)

Non-Obese vs Obese: Odds Ratio (OR): 1.05 (95% CI 0.64 to 1.73), p = 0.84, Regression, Logistic
Non-Obese vs Obese: Odds Ratio (OR): 1.07 (95% CI 0.65 to 1.75), p = 0.79, Regression, Logistic
Non-Obese vs Obese: Odds Ratio (OR): 1.26 (95% CI 0.71 to 2.24), p = 0.43, Regression, Logistic

Population analysed: Pregnant women with antibody titer data at 30 days post vaccination. Analyses include all women with available antibody titer data at the necessary time points.

Primary outcome: Maternal HAI Antibody Titers

Time frame: at delivery. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Non-Obese n = 181	Obese n = 79
A/H1N1 Strain	23.5 (18.5 to 29.8)	32.5 (22.6 to 46.8)
A/H3N2 Strain	31.6 (24.8 to 40.4)	32.7 (22.3 to 47.8)
B/Massachusetts Strain	10.3 (8.6 to 12.3)	16.3 (11.9 to 22.2)
B/Brisbane Strain	8.4 (7.2 to 9.9)	11.4 (8.5 to 15.4)

Non-Obese vs Obese: Odds Ratio (OR): 1.39 (95% CI 0.84 to 2.32), p = 0.20, Regression, Logistic
Non-Obese vs Obese: Odds Ratio (OR): 1.09 (95% CI 0.66 to 1.80), p = 0.74, Regression, Logistic
Non-Obese vs Obese: Odds Ratio (OR): 1.89 (95% CI 1.04 to 3.44), p = 0.04, Regression, Logistic

Population analysed: Pregnant women with antibody titer data at delivery. Analyses include all women with available antibody titer data at the necessary time points.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from enrollment up until delivery of the infant. This time frame varied from 3-8 months depending on gestational age at enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Obese	0 of 201 (0%)	0 of 201 (0%)	0 of 201
Obese	0 of 86 (0%)	0 of 86 (0%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28778612Christian LM, Beverly C, Mitchell AM, Karlsson E, Porter K, Schultz-Cherry S, Ramilo O. Effects of prior influenza virus vaccination on maternal antibody responses: Implications for achieving protection in the newborns. Vaccine. 2017 Sep 18;35(39):5283-5290. doi: 10.1016/j.vaccine.2017.05.050. Epub 2017 Aug 1.
For more information or to applyLink provided by the sponsor.

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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.

Lisa M. Christian, PhD principal investigator

Ohio State University

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 Pregnancy, run by Lisa Christian 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 2019. 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?

Yes. Results are posted in the registry (first posted 28 Aug 2019). 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?

Maternal HAI Antibody Titers (time frame: 30-days after influenza vaccination). 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?

On the ClinicalTrials.gov record for NCT02148874, which also lists 1 linked publication.

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 24 Sep 2019.