An observational study in Influenza, Human, Pregnancy and Birth Defect, sponsored by Seqirus. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Seqirus (part of CSL Limited) · Observational
Among 51 studies in Influenza, Human by Seqirus — none open to participants now, none under way, none of them phase 3. Influenza, Human · Seqirus.
Among the 51 studies in Influenza, Human by Seqirus, this one is one of 4 that started in 2017, is one of 3 observational ones, and was the 37th registered.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's enrollment of 692 is above the median of 388 across 332 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →None of the 51 studies in Influenza, Human by Seqirus is open now.
Of the 119 Influenza, Human studies recruiting now, 62 (52%) set no upper age limit and 47 (39%) stop at 75 or younger; 31 take children under 18; 65 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →51 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2017.
Median enrollment 610 across the 48 interventional studies, 490 across the 3 observational. Of the 49 that completed or were terminated, 31 (63%) have results posted.
Seqirus is the lead sponsor of 53 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 10 (67%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 51 studies in Influenza, Human by Seqirus, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:
Exclusion Criteria:
Flucelvax Trivalent or Quadrivalent exposure in pregnancy
Biological: Flucelvax Trivalent Influenza Vaccine · Biological: Flucelvax Quadrivalent Influenza Vaccine
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)
Also known as: Flucelvax
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)
Also known as: Flucelvax Quadrivalent
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
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 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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Dec 2020, 39 months.
Of 37 industry-sponsored observational studies under Influenza, Human, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 34. This study's 39 months is above that.
Counting every sponsor, half of 133 studies reached it within 21 months; a quarter within 7 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.