Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry

An observational study of Influenza, run by GlaxoSmithKline at 1 site in United States.

Completed

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

Trial summary

The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Data collection
Type of treatment: Vaccines
How many people: 507 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2014to 31 May 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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Pregnant women, residing in the US, vaccinated with any of the 4 GSK sIIVs during pregnancy or within 28 days preceding conception and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.

Who may be able to join

A subject will be included in the Registry if all of the following criteria are met:
Exposure to GSK sIIVs occurs during pregnancy or within 28 days preceding conception.
Subject is a US resident.
A HCP is identified (name, address and phone number).
Subject can be identified (by GSK or HCP).
Data from registered subjects will be included in the analyses if the following criterion is met:
Pregnancy is ongoing and the outcome is unknown at the time of initial report.

Who cannot join

Data from registered subjects will not be included in the analyses if the following criterion is met:
Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Wilmington, North Carolina, 284013331

Other trials in United States

About this study

Official title: Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Fluarix or Fluarix Quadrivalent or FluLaval or FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception.

Read the detailed description

This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS).

Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q2 2014 to Q2 2019.

The intent of the Registry is to prospectively collect data such as vaccination with GSK sIIVs during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.

Conditions: Influenza
Being tested: Data collection
Keywords: Fluarix Quadrivalent, Fluarix, FluLaval, FluLaval Quadrivalent, Pregnancy Registry, Pregnancy outcome
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Data collectionOther
Initial and follow-up data was collected using questionnaires.

Study groups in NCT02148211
Study group	Role	What they receive
Exposed cohort		Pregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception. Receives: Other: Data collection

What is being measured

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

Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure, in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval During Pregnancy or Within 28 Days Preceding Conception
Exposures and outcomes were stratified by trimester of exposure: first (1st), second (2nd), third (3rd) and unknown trimester (Tr?) multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated based on the date of the last menstrual period. The 2nd trimester was considered to begin at week 14 and the 3rd trimester begun at week 28. The presence or absence of birth defects or other abnormalities was evaluated within each of the preceding outcome categories. Ongoing = subject still pregnant at the time of last contact. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. Unknown = unknown outcome at the time of last contact.
Measured: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without congenital anomalies (Live infants without CA.); Spontaneous abortions with no apparent congenital anomalies (Sp. abortions with no ACA); Spontaneous abortions with congenital anomalies (Sp. abortions with CA). One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020.
Measured: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix During Pregnancy or Within 28 Days Preceding Conception
Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Unknown = unknown outcome at the time of last contact.
Measured: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Number of Subjects Reported With Exposure and Outcomes Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without CA; Live infants with CA; Sp. abortions with no ACA; Sp. abortions with CA; Stillbirth with no ACA. Unknown = unknown pregnancy outcome at the time of last contact. One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020.
Measured: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product during the clinical study. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
Number of Subjects Reported With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019

Timeline

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

1 Jun 201431 May 2019

First posted28 May 2014 (estimated)
Study start1 Jun 2014
Primary completion31 May 2019
Study completion31 May 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 InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: 507 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02148211
Sponsor's protocol ID: 201476
Other IDs: EUPAS6521
Status last verified: May 2020
First submitted: 22 May 2014
Last updated: 12 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother. 2022 Dec 31;18(1):1932213. doi: 10.1080/21645515.2021.1932213. Epub 2021 Jun 3.
PubMed 34082643

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

Active, not recruitingEarly Phase 1
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Influenza, Human
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Fluarix or Fluarix Quadrivalent or FluLaval or FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception.
ClinicalTrials.gov ID: NCT02148211
Acronym / sponsor ID: 201476
Conditions: Influenza
Keywords: Fluarix Quadrivalent, Fluarix, FluLaval, FluLaval Quadrivalent, Pregnancy Registry, Pregnancy outcome
Study type: Observational
Recruitment status: Completed
Enrolment: 507 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Jun 2014 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 28 May 2014 (estimated)
Results: Posted 12 Jun 2020

Clinical summary

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

Detailed description

This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Exposed cohort	–	Other: Data collectionPregnant women, vaccinated with any of the 4 GSK seasonal Inactivated Influenza Vaccine(s) (GSK sIIVs): Fluarix/ FluLaval/Fluarix Quadrivalent /FluLaval Quadrivalent during pregnancy or within 28 days preceding conception.

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Pregnant women, residing in the US, vaccinated with any of the 4 GSK sIIVs during pregnancy or within 28 days preceding conception and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.

Key inclusion criteria (7 listed)

Exposure to GSK sIIVs occurs during pregnancy or within 28 days preceding conception.
Subject is a US resident.
A HCP is identified (name, address and phone number).
Subject can be identified (by GSK or HCP).
Data from registered subjects will be included in the analyses if the following criterion is met:

Key exclusion criteria (2 listed)

Data from registered subjects will not be included in the analyses if the following criterion is met:
Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus.

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
Data collectionInitial and follow-up data was collected using questionnaires.	Other	Exposed cohort

Primary outcome

Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure, in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval During Pregnancy or Within 28 Days Preceding Conception
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Exposures and outcomes were stratified by trimester of exposure: first (1st), second (2nd), third (3rd) and unknown trimester (Tr?) multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated based on the date of the last menstrual period. The 2nd trimester was considered to begin at week 14 and the 3rd trimester begun at week 28. The presence or absence of birth defects or other abnormalities was evaluated within each of the preceding outcome categories. Ongoing = subject still pregnant at the time of last contact. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020. Unknown = unknown outcome at the time of last contact.
Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without congenital anomalies (Live infants without CA.); Spontaneous abortions with no apparent congenital anomalies (Sp. abortions with no ACA); Spontaneous abortions with congenital anomalies (Sp. abortions with CA). One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020.
Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix During Pregnancy or Within 28 Days Preceding Conception
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Unknown = unknown outcome at the time of last contact.
Number of Subjects Reported With Exposure and Outcomes Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)
Exposure and outcomes were stratified by trimester of exposure: 1st, 2nd, 3rd and Tr?; multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated as described in the first outcome. Results were presented for the following categories: Ongoing, Live infants without CA; Live infants with CA; Sp. abortions with no ACA; Sp. abortions with CA; Stillbirth with no ACA. Unknown = unknown pregnancy outcome at the time of last contact. One subject had FluLaval Quadrivalent and Fluarix Quadrivalent listed as vaccine used. Therefore, same case was included in the respective table of each product in "Live infants without CA, 3rd Tr." category. Note: The remaining pregnancies were ongoing at the time of last contact by the study staff. No further information on the outcome of these pregnancies was available as of 1st April 2020.
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product during the clinical study. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Reported With Serious Adverse Events (SAEs)
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Results and safety

Results posted to the registry on 12 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exposed Group	507	155

Primary outcome: Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure, in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval During Pregnancy or Within 28 Days Preceding Conception

Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births). Count of participants. Unit: Participants

Measure	Exposure Group n = 8
Ongoing, 1st Tr.	2
Ongoing, 2nd Tr.	3
Ongoing, 3rd Tr.	0
Ongoing, Tr?	1
Unknown, 1st Tr.	0
Unknown, 2nd Tr.	0
Unknown, 3rd Tr.	2
Unknown, Tr?	0

Population analysed: Analysis was performed on pregnant women vaccinated with FluLaval vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study and who completed the study period.

Primary outcome: Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception

Measure	Exposure Group n = 33
Ongoing, 1st Tr.	0
Ongoing, 2nd Tr.	1
Ongoing, 3rd Tr.	1
Ongoing, Tr?	6
Live infants without CA, 1st Tr.	4
Live infants without CA, 2nd Tr.	6
Live infants without CA, 3rd Tr.	10
Live infants without CA, Tr?	3

Population analysed: Analysis was performed on pregnant women vaccinated with FluLaval Quadrivalent vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study, and who completed the study period.

Primary outcome: Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix During Pregnancy or Within 28 Days Preceding Conception

Measure	Exposure Group n = 1
Unknown, 1st Tr.	0
Unknown, 2nd Tr.	0
Unknown, 3rd Tr.	0
Unknown, Tr?	1

Population analysed: Analysis was performed on pregnant women vaccinated with Fluarix vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study, and who completed the study period.

Primary outcome: Number of Subjects Reported With Exposure and Outcomes Stratified by Trimester of Exposure in Pregnant Women Intentionally or Unintentionally Vaccinated With Fluarix Quadrivalent During Pregnancy or Within 28 Days Preceding Conception

Measure	Exposure Group n = 114
Ongoing, 1st Tr.	5
Ongoing, 2nd Tr.	2
Ongoing, 3rd Tr.	4
Ongoing, Tr?	15
Live infants without CA, 1st Tr.	15
Live infants without CA, 2nd Tr.	31
Live infants without CA, 3rd Tr.	21
Live infants without CA, Tr?	12

Population analysed: Analysis was performed on pregnant women vaccinated with Fluarix Quadrivalent vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study, and who completed the study period.

Adverse events

Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exposure Group	9 of 507 (1.8%)	507 of 507 (100%)	2 of 507

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34082643Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother. 2022 Dec 31;18(1):1932213. doi: 10.1080/21645515.2021.1932213. Epub 2021 Jun 3.

Related trials for Influenza

Active, not recruitingEarly Phase 1
Vaccine Pandemic Preparedness Through Airway Immunology Characterization
Influenza, Human
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

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.

GSK Clinical Trials study director

GlaxoSmithKline

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 GlaxoSmithKline 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 7 inclusion and 2 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 12 Jun 2020. 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 12 Jun 2020). 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?

Number of Subjects Reported With Exposure and Outcomes, Stratified by Trimester of Exposure, in Pregnant Women Intentionally or Unintentionally Vaccinated With FluLaval During Pregnancy or Within 28 Days Preceding Conception (time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019: for each subject, data was collected within 2 months of estimated date of delivery (EDD) and follow-up 6 and 12 months after EDD (for all live births)). 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?

On the ClinicalTrials.gov record for NCT02148211, 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 12 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.