Eligibility, female only, with Influenza. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 ConceptionPrimary· 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
Ongoing, 1st Tr.
Group
Value
95% CI
Exposure Group
2
Ongoing, 2nd Tr.
Group
Value
95% CI
Exposure Group
3
Ongoing, 3rd Tr.
Group
Value
95% CI
Exposure Group
0
Ongoing, Tr?
Group
Value
95% CI
Exposure Group
1
Unknown, 1st Tr.
Group
Value
95% CI
Exposure Group
0
Unknown, 2nd Tr.
Group
Value
95% CI
Exposure Group
0
Unknown, 3rd Tr.
Group
Value
95% CI
Exposure Group
2
Unknown, Tr?
Group
Value
95% CI
Exposure Group
0
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 ConceptionPrimary· 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 Flu
Ongoing, 1st Tr.
Group
Value
95% CI
Exposure Group
0
Ongoing, 2nd Tr.
Group
Value
95% CI
Exposure Group
1
Ongoing, 3rd Tr.
Group
Value
95% CI
Exposure Group
1
Ongoing, Tr?
Group
Value
95% CI
Exposure Group
6
Live infants without CA, 1st Tr.
Group
Value
95% CI
Exposure Group
4
Live infants without CA, 2nd Tr.
Group
Value
95% CI
Exposure Group
6
Live infants without CA, 3rd Tr.
Group
Value
95% CI
Exposure Group
10
Live infants without CA, Tr?
Group
Value
95% CI
Exposure Group
3
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 ConceptionPrimary· 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.
Unknown, 1st Tr.
Group
Value
95% CI
Exposure Group
0
Unknown, 2nd Tr.
Group
Value
95% CI
Exposure Group
0
Unknown, 3rd Tr.
Group
Value
95% CI
Exposure Group
0
Unknown, Tr?
Group
Value
95% CI
Exposure Group
1
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 ConceptionPrimary· 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 li
Ongoing, 1st Tr.
Group
Value
95% CI
Exposure Group
5
Ongoing, 2nd Tr.
Group
Value
95% CI
Exposure Group
2
Ongoing, 3rd Tr.
Group
Value
95% CI
Exposure Group
4
Ongoing, Tr?
Group
Value
95% CI
Exposure Group
15
Live infants without CA, 1st Tr.
Group
Value
95% CI
Exposure Group
15
Live infants without CA, 2nd Tr.
Group
Value
95% CI
Exposure Group
31
Live infants without CA, 3rd Tr.
Group
Value
95% CI
Exposure Group
21
Live infants without CA, Tr?
Group
Value
95% CI
Exposure Group
12
Number of Subjects Reported With Unsolicited Adverse Events (AEs)Primary· 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.
Group
Value
95% CI
Exposure Group
507
Number of Subjects Reported With Serious Adverse Events (SAEs)Primary· 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.
Group
Value
95% CI
Exposure Group
9
Adverse events — posted to ClinicalTrials.gov
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 12 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02148211.