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

NCT02148211 | Completed Results FDA Drug

• 2 other identifiers: 201476EUPAS6521
• Study Type: observational
• Target: 507
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Fluarix Quadrivalent; Fluarix; FluLaval; FluLaval Quadrivalent; Pregnancy Registry; Pregnancy outcome

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

Study Arms (1)

Exposed cohort

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.

Other: Data collection

Interventions

Data collection OTHER

Initial and follow-up data was collected using questionnaires.

Exposed cohort

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, residing in the US, vaccinated with any of the 4 GSK sIIVs during pregnancy or within 28 days preceding conception and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wilmington, North Carolina, 284013331, United States

Location

Related Publications (1)

• Nwoji U. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother. 2022 Dec 31;18(1):1932213. doi: 10.1080/21645515.2021.1932213. Epub 2021 Jun 3.

  PMID: 34082643 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: June 1, 2014
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 12, 2020
• Results First Posted: June 12, 2020

Record last verified: 2020-05

Locations

US (1)