Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry

Influenza Clinical Trial

Official title:

Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Fluarix or Fluarix Quadrivalent or FluLaval or FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148211
• Other study ID #: 201476
• Secondary ID: EUPAS6521
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza

Intervention

Other:
• Data collection
Initial and follow-up data was collected using questionnaires.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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)
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.	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)
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.	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)
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.	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)
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.	Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019
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.	Data collected for a minimum of 5 years starting from June 1, 2014 till May 31, 2019