InfluenzaNCT02000466
FluLaval® Quadrivalent Pregnancy Registry
An observational study of Influenza, run by GlaxoSmithKline.
Trial summary
The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Read more about this study
- Who is it for?
- Ages 12 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Data collection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 64 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women, residing in the US, exposed to FluLaval Quadrivalent 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 vaccine 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.
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. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
About this study
Official title: FluLaval® Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With FluLaval® Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent 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 will be collected prospectively.
Read the detailed description
Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.
Pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD from 30 November 2013 to 31 May 2018.
- Conditions
- Influenza
- Being tested
- Data collection
- Keywords
- Women, Pregnancy exposure, FluLaval Quadrivalent, Pregnancy outcome, Pregnancy Registry
- 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 will be collected using questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Exposed cohort | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception
Measured: Up to 12 months after EDD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: GSK has merged all individual pregnancy registries, which are terminated, for its seasonal influenza vaccines into one combined registry, EPI-FLU-039 VS US PR.
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 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000466
- Sponsor's protocol ID
- 201086
- Status last verified
- Oct 2014
- First submitted
- 27 Nov 2013
- Last updated
- 27 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FluLaval® Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With FluLaval® Quadrivalent During Pregnancy or Within 28 Days Preceding Conception
- ClinicalTrials.gov ID
- NCT02000466
- Acronym / sponsor ID
- 201086
- Conditions
- Influenza
- Keywords
- Women, Pregnancy exposure, FluLaval Quadrivalent, Pregnancy outcome, Pregnancy Registry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: GSK has merged all individual pregnancy registries, which are terminated, for its seasonal influenza vaccines into one combined registry, EPI-FLU-039 VS US PR.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- 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 purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent 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 will be collected prospectively.
Detailed description
Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.
Pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD from 30 November 2013 to 31 May 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposed cohort | – | Other: Data collection |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women, residing in the US, exposed to FluLaval Quadrivalent 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 vaccine 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. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
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 will be collected using questionnaires | Other | Exposed cohort |
Primary outcome
Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception
Time frame: Up to 12 months after EDD
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by GlaxoSmithKline.
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: withdrawn, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception (time frame: Up to 12 months after EDD). 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 27 Oct 2014.