Influenza
Conditions
Keywords
Fluarix Quadrivalent, Fluarix, FluLaval, FluLaval Quadrivalent, Pregnancy Registry, Pregnancy outcome
Brief 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.
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.
Interventions
OTHERData collection
Initial and follow-up data was collected using questionnaires.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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) | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exposure Group 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. | 507 |
| Total | 507 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 352 |
Baseline characteristics
| Characteristic | Exposure Group | — |
|---|---|---|
| Age, Customized ≤ 18 | 4 Participants | — |
| Age, Customized > 18 and < 64 | 329 Participants | — |
| Age, Customized Age not specified | 171 Participants | — |
| Age, Customized Not applicable | 3 Participants | — |
| Race/Ethnicity, Customized | — | — Participants |
| Sex: Female, Male Female | 507 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 507 |
| other Total, other adverse events | 507 / 507 |
| serious Total, serious adverse events | 9 / 507 |
Outcome results
Primary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exposure Group | 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 | Unknown, 1st Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, Tr? | 1 Participants |
| Exposure Group | 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 | Unknown, 2nd Tr. | 0 Participants |
Primary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exposure Group | 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 | Ongoing, 2nd Tr. | 2 Participants |
| Exposure Group | 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 | Ongoing, 3rd Tr. | 4 Participants |
| Exposure Group | 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 | Live infants without CA, 3rd Tr. | 21 Participants |
| Exposure Group | 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 | Live infants with CA, Tr? | 0 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, 1st Tr. | 1 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with CA, 1st Tr. | 0 Participants |
| Exposure Group | 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 | Stillbirth with no ACA, 1st Tr. | 1 Participants |
| Exposure Group | 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 | Stillbirth with no ACA, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Stillbirth with no ACA, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, 1st Tr. | 1 Participants |
| Exposure Group | 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 | Unknown, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Ongoing, 1st Tr. | 5 Participants |
| Exposure Group | 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 | Ongoing, Tr? | 15 Participants |
| Exposure Group | 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 | Live infants without CA, 1st Tr. | 15 Participants |
| Exposure Group | 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 | Live infants without CA, 2nd Tr. | 31 Participants |
| Exposure Group | 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 | Live infants without CA, Tr? | 12 Participants |
| Exposure Group | 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 | Live infants with CA, 1st Tr. | 0 Participants |
| Exposure Group | 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 | Live infants with CA, 2nd Tr. | 3 Participants |
| Exposure Group | 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 | Live infants with CA, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, Tr? | 0 Participants |
| Exposure Group | 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 | Sp. abortions with CA, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with CA, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with CA, Tr? | 0 Participants |
| Exposure Group | 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 | Stillbirth with no ACA, Tr? | 0 Participants |
| Exposure Group | 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 | Unknown, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, Tr? | 3 Participants |
Primary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exposure Group | 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 | Ongoing, 2nd Tr. | 3 Participants |
| Exposure Group | 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 | Ongoing, Tr? | 1 Participants |
| Exposure Group | 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 | Unknown, 1st Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, Tr? | 0 Participants |
| Exposure Group | 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 | Ongoing, 1st Tr. | 2 Participants |
| Exposure Group | 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 | Ongoing, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Unknown, 3rd Tr. | 2 Participants |
Primary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exposure Group | 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 | Ongoing, 3rd Tr. | 1 Participants |
| Exposure Group | 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 | Ongoing, Tr? | 6 Participants |
| Exposure Group | 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 | Live infants without CA, 3rd Tr. | 10 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Ongoing, 1st Tr. | 0 Participants |
| Exposure Group | 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 | Ongoing, 2nd Tr. | 1 Participants |
| Exposure Group | 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 | Live infants without CA, 1st Tr. | 4 Participants |
| Exposure Group | 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 | Live infants without CA, 2nd Tr. | 6 Participants |
| Exposure Group | 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 | Live infants without CA, Tr? | 3 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, 1st Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with no ACA, Tr? | 1 Participants |
| Exposure Group | 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 | Sp. abortions with CA, 1st Tr. | 1 Participants |
| Exposure Group | 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 | Sp. abortions with CA, 2nd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with CA, 3rd Tr. | 0 Participants |
| Exposure Group | 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 | Sp. abortions with CA, Tr? | 0 Participants |
Primary
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.
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
Population: Analysis was performed on pregnant women vaccinated with GSK sIIV vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposure Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 9 Participants |
Primary
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.
Time frame: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
Population: Analysis was performed on pregnant women vaccinated with GSK sIIV vaccine during pregnancy or within 28 days preceding conception who volunteered to take part of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exposure Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 507 Participants |