Influenza, HumanNCT03438487
Flucelvax (TIVc or QIVc) Pregnancy Registry
An observational study of Influenza, Human and Pregnancy, run by Seqirus at 1 site in United States.
Trial summary
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Pregnancy, Birth Defect
- What is being tested?
- Flucelvax Trivalent Influenza Vaccine and Flucelvax Quadrivalent Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 692 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 31 Dec 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include pregnant women within the US who were immunized with the TIVc or the QIVc vaccine as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their HCP. Women under 18 can be included in the study as long as parental consent can be obtained. De-identified data on minors will be accepted into the study if permitted by laws and regulations.
Who may be able to join
- Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:
- Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
- Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
- Reporter (e.g. HCP) contact information to allow for follow-up
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.
- Conditions
- Influenza, Human, Pregnancy, Birth Defect
- Being tested
- Flucelvax Trivalent Influenza Vaccine, Flucelvax Quadrivalent Influenza Vaccine
- Medical subject headings
- Influenza, Human, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flucelvax Trivalent Influenza VaccineBiological
Also called Flucelvax
Flucelvax is a cell culture seasonal trivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage or B/Victoria lineage
Vaccine exposure in routine care (no vaccination per protocol)
Flucelvax Quadrivalent Influenza VaccineBiological
Also called Flucelvax Quadrivalent
Flucelvax Quadrivalent is a cell culture seasonal quadrivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage, 4) B/Victoria lineage
Vaccine exposure in routine care (no vaccination per protocol)
| Study group | Role | What they receive |
|---|---|---|
| Flucelvax Trivalent or Quadrivalent Influenza Vaccine | Flucelvax Trivalent or Quadrivalent exposure in pregnancy Receives: Biological: Flucelvax Trivalent Influenza Vaccine; Biological: Flucelvax Quadrivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Number of cases for pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination
Measured: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases with major congenital malformations among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Measured: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases with events of preterm birth among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Measured: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases with low birth weight among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Measured: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Sep 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head Epidemiology, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438487
- Sponsor's protocol ID
- V130_11OB
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy
- ClinicalTrials.gov ID
- NCT03438487
- Acronym / sponsor ID
- V130_11OB
- Conditions
- Influenza, Human, Pregnancy, Birth Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Feb 2018 (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 study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flucelvax Trivalent or Quadrivalent Influenza Vaccine | – | Biological: Flucelvax Trivalent Influenza Vaccine, Biological: Flucelvax Quadrivalent Influenza VaccineFlucelvax Trivalent or Quadrivalent exposure in pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women within the US who were immunized with the TIVc or the QIVc vaccine as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their HCP. Women under 18 can be included in the study as long as parental consent can be obtained. De-identified data on minors will be accepted into the study if permitted by laws and regulations.
Key inclusion criteria (4 listed)
- Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:
- Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
- Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
- Reporter (e.g. HCP) contact information to allow for follow-up
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Flucelvax Trivalent Influenza VaccineAlso: FlucelvaxFlucelvax is a cell culture seasonal trivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage or B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol) | Biological | Flucelvax Trivalent or Quadrivalent Influenza Vaccine |
| Flucelvax Quadrivalent Influenza VaccineAlso: Flucelvax QuadrivalentFlucelvax Quadrivalent is a cell culture seasonal quadrivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage, 4) B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol) | Biological | Flucelvax Trivalent or Quadrivalent Influenza Vaccine |
Primary outcome
Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Number of cases for pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination
Safety Objective: Number of cases with major congenital malformations among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases with events of preterm birth among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases with low birth weight among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Head Epidemiology study director
Seqirus
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, Human and Pregnancy, run by Seqirus 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 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 4 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. (time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks). 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 4 Nov 2022.