Trial Outcomes & Findings for Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry (NCT NCT02148211)
NCT ID: NCT02148211
Last Updated: 2020-06-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
507 participants
Primary outcome timeframe
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)
Results posted on
2020-06-12
Participant Flow
Participant milestones
| Measure |
Exposed 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.
|
|---|---|
|
Overall Study
STARTED
|
507
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
352
|
Reasons for withdrawal
| Measure |
Exposed 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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
352
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exposure Group
n=507 Participants
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.
|
|---|---|
|
Age, Customized
≤ 18
|
4 Participants
n=507 Participants
|
|
Age, Customized
> 18 and < 64
|
329 Participants
n=507 Participants
|
|
Age, Customized
Age not specified
|
171 Participants
n=507 Participants
|
|
Age, Customized
Not applicable
|
3 Participants
n=507 Participants
|
|
Sex: Female, Male
Female
|
507 Participants
n=507 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=507 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=8 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=33 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=1 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=114 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=507 Participants
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.
|
|---|---|
|
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
|
507 Participants
|
PRIMARY outcome
Timeframe: Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=507 Participants
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.
|
|---|---|
|
Number of Subjects Reported With Serious Adverse Events (SAEs)
|
9 Participants
|
Adverse Events
Exposure Group
Serious events: 9 serious events
Other events: 507 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Exposure Group
n=507 participants at risk
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.
|
|---|---|
|
Congenital, familial and genetic disorders
Cleft lip and palate
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Infections and infestations
Injection site cellulitis
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.59%
3/507 • Number of events 3 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Surgical and medical procedures
Caesarean section
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
Other adverse events
| Measure |
Exposure Group
n=507 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Crying
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Injection site erythema
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Injection site edema
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Injection site pain
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Injection site swelling
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Injection site warmth
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Malaise
|
0.39%
2/507 • Number of events 2 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
General disorders
Pain
|
0.39%
2/507 • Number of events 2 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Immune system disorders
Hypersensitivity
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Immune system disorders
Multiple allergies
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Infections and infestations
Influenza
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Contraindicated product administered
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Expired product administered
|
0.99%
5/507 • Number of events 5 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
99.2%
503/507 • Number of events 504 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Exposure via body fluid
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Extra dose administered
|
2.0%
10/507 • Number of events 10 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Maternal exposure before pregnancy
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.39%
2/507 • Number of events 2 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Maternal exposure timing unspecified
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Wrong product administered
|
0.99%
5/507 • Number of events 5 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Injury, poisoning and procedural complications
Wrong technique in product usage process
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Nervous system disorders
Neuritis
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labor
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.39%
2/507 • Number of events 2 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Live birth
|
20.3%
103/507 • Number of events 103 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.79%
4/507 • Number of events 4 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.39%
2/507 • Number of events 2 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.99%
5/507 • Number of events 5 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged pregnancy
|
0.39%
2/507 • Number of events 2 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Twin pregnancy
|
0.59%
3/507 • Number of events 3 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord around neck
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Psychiatric disorders
Insomnia
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.20%
1/507 • Number of events 1 • Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
All-cause mortality reported data are fetal deaths. Only unanticipated AEs were collected in the study. Anticipated AEs were not assessed/monitored.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER