Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-17

Study Completion Date

2022-02-28

Brief Summary

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Primary Objective:

To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes

Secondary Objective:

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Detailed Description

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Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.

Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Pregnant women from the VAP00003 Study and their offspring - Pregnant women from the VAP00003 Study (NCT03694392) between September 2018 and May 2020 (2 influenza seasons), and infants born from this cohort of pregnant women

Flublok Quadrivalent influenza vaccine RIV4

Intervention Type BIOLOGICAL

Route of administration: Intramuscular

Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Intervention Type BIOLOGICAL

Route of administration: Intramuscular

Interventions

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Flublok Quadrivalent influenza vaccine RIV4

Route of administration: Intramuscular

Intervention Type BIOLOGICAL

Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Route of administration: Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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RIV4 SD-IIV4

Eligibility Criteria

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Inclusion Criteria

Pregnant women:

* Laboratory or medical professional confirmation of pregnancy
* Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during pregnancy or within 28 days preceding conception

Offspring:

Exclusion Criteria

* Documented receipt of any other influenza vaccine at any other time during the pregnancy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes