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Safety of RIV4 Versus IIV4 in Pregnant Women

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: NCT03969641
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Boston Medical Center
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

Brief Summary:

This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers.

Prior influenza vaccine history will be verified by medical record review when possible.

Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 8 days following vaccination using either identical web-based or paper diaries, depending on study participant preference.

Maternal serum samples will be collected for antibody titers relevant to Influenza at time points that include: prior to vaccination and ~29 days post vaccination. When feasible, maternal blood at delivery and cord blood serum will be analyzed for the same antibody titers.

Pregnant women will be followed through delivery with comprehensive obstetric and neonatal outcomes obtained from medical record review for 90 days of life.


Condition or disease Intervention/treatment Phase
Safety Adverse Event Following Immunisation Birth Outcomes Biological: Quadrivalent Recombinant Influenza Vaccine Biological: Quadrivalent Inactivated Influenza Vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Clinical Trial to Compare Adverse Birth Outcomes in Pregnant Women Receiving Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4)
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : September 14, 2021
Estimated Study Completion Date : September 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: RIV4
The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology
Biological: Quadrivalent Recombinant Influenza Vaccine
The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology
Other Name: Flublok Quadrivalent

Active Comparator: IIV4
Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.
Biological: Quadrivalent Inactivated Influenza Vaccine
Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.
Other Name: Flulaval




Primary Outcome Measures :
  1. Adverse birth outcomes in pregnant women vaccinated with RIV4 versus IIV4 [ Time Frame: 12 months ]

    As measured by the proportion of women experiencing one of the following:

    • Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.


Secondary Outcome Measures :
  1. Preterm birth after RIV4 versus IIV4 vaccination [ Time Frame: 12 months ]
    As measured by proportions of preterm birth after RIV4 versus IIV4 vaccination

  2. Combined fetal and neonatal death after RIV4 versus IIV4 vaccination [ Time Frame: 12 months ]
    As measured by proportions of combined fetal and neonatal death after RIV4 versus IIV4 vaccination

  3. Spontaneous abortion after RIV4 versus IIV4 vaccination [ Time Frame: 12 months ]
    As measured by proportions of spontaneous abortion after RIV4 versus IIV4 vaccination

  4. Pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 8 days after vaccination with RIV4 versus IIV4 [ Time Frame: 8 days ]
    As measured by proportions of moderate/severe solicited reactogenicity events in pregnant women vaccinated with RIV4 versus IIV4



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pregnant, as determined by medical history
  2. Age ≥ 18 years of age at enrollment
  3. Intention of receiving influenza vaccine based on ACIP-CDC guidelines
  4. Willing to provide written informed consent prior to initiation of any study procedures
  5. Gestational age at vaccination ≤ 34 weeks 0 days based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA-EDD) will be based on reconciliation of "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
  6. English or Spanish literate
  7. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.

Exclusion Criteria:

  1. Influenza vaccine receipt during 2019-2020 or 2020-2021 influenza season prior to study enrollment.
  2. Participation in this study in 2019-2020 influenza season
  3. Any condition that may interfere with assessment of local injection site reactions, e.g. obscuring tattoos
  4. Known or suspected immunosuppression as a result of an underlying illness or treatment
  5. Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months
  6. Use of oral or parenteral corticosteroids (≥ 20mg/day prednisone equivalent) or high-dose inhaled glucocorticoid for ≥ 14 consecutive days within the preceding 30 days
  7. Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants (a daily aspirin is acceptable)
  8. Has a history of receiving immunoglobulin or other blood product (with exception of Rh immunoglobulin) within the 3 months prior to study vaccination.
  9. History of febrile illness (> 100.4°F or 38°C) within the past 24 hours prior to study vaccination
  10. Contraindication to IIV or RIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein
  11. History of Guillain-Barré syndrome within 6 weeks of a prior dose of any influenza vaccine
  12. Receipt of any licensed vaccine within 7 days prior to study vaccination or intention of receiving any vaccines during 8-day post-vaccination period
  13. Receipt of live vaccine during current pregnancy
  14. Signs or symptoms of active preterm labor, defined as regular uterine contractions with cervical change (dilation/effacement)
  15. Known multi-fetal gestation or fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound
  16. Anyone who is already enrolled or plans to enroll in another randomized clinical trial with any drug, vaccine or medical device. Co-enrollment in observational or behavioral intervention studies are allowed at any time
  17. Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives.
  18. Anyone who is a relative of any research study personnel or is an employee supervised by study staff

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): NCT03969641


Contacts
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Contact: Geeta K Swamy, MD 919-681-5220 geeta.swamy@duke.edu
Contact: Kristen M Gunnell, BS 919-684-8891 kristen.gunnell@duke.edu

Locations
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United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Stephen Pelton, MD       spelton@bu.edu   
Contact: Confidence Achilike       achilike@bu.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Kristen M Gunnell       kristen.gunnell@duke.edu   
Contact: Kristin Weaver       kristin.weaver@duke.edu   
Principal Investigator: Geeta K Swamy, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Elizabeth Schlaudecker, MD, MPH       elizabeth.schlaudecker@cchmc.org   
Contact: Nancy Back, RN, MPH       nancy.back@cchmc.org   
Sponsors and Collaborators
Duke University
Children's Hospital Medical Center, Cincinnati
Boston Medical Center
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Geeta K Swamy, MD Duke University
Principal Investigator: Karen R Broder, MD Centers for Disease Control and Prevention
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03969641    
Other Study ID Numbers: Pro00101707
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
Vaccination
Safety
Birth outcomes
Flublok
Pregnant
Influenza
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs