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Afluria Pregnancy Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442582
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Seqirus

Brief Summary:
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.

Condition or disease Intervention/treatment
Influenza, Human Pregnancy Birth Defect Biological: Afluria Influenza Vaccine

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Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Afluria, a Seasonal Influenza Vaccine, During Pregnancy
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Afluria
Afluria exposure in pregnancy
Biological: Afluria Influenza Vaccine

Afluria is a seasonal influenza vaccine

Vaccine exposure in routine care (no vaccination per protocol)

Other Name: Afluria




Primary Outcome Measures :
  1. Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks ]
    Pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination

  2. Safety Objective: Number of cases with events of major congenital malformations among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks ]
  3. Safety Objective: Number of cases of events of preterm birth among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks ]
  4. Safety Objective: Number of cases of events of low birth weight among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population will include pregnant women within the US who were immunized with Afluria as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their HCP.

Women under 18 can be included in the study as long as parental consent can be obtained, according to IRB requirements and local laws and regulations.

Criteria

Inclusion Criteria:

Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:

  • Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
  • Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
  • Reporter (e.g. HCP) contact information to allow for follow-up

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442582


Contacts
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Contact: Clinical Study Disclosure Manager Use Email Seqirus.Clinicaltrials@Seqirus.com

Locations
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United States, North Carolina
Syneos Health Recruiting
Wilmington, North Carolina, United States, 28405
Contact: Use Central Contact       Seqirus.Clinicaltrials@Seqirus.com   
Sponsors and Collaborators
Seqirus
Investigators
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Study Director: Head Epidemiology Seqirus

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Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT03442582     History of Changes
Other Study ID Numbers: CSLCT-OBS-17-15
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Influenza, Human
Congenital Abnormalities
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs