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Safety of RIV4 Versus IIV4 in Pregnant Women

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ClinicalTrials.gov Identifier: NCT03969641
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Boston Medical Center
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE September 5, 2019
Estimated Primary Completion Date September 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Preterm birth after RIV4 versus IIV4 vaccination [ Time Frame: 12 months ]
    As measured by proportions of preterm birth after RIV4 versus IIV4 vaccination
  • 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
  • Spontaneous abortion after RIV4 versus IIV4 vaccination [ Time Frame: 12 months ]
    As measured by proportions of spontaneous abortion after RIV4 versus IIV4 vaccination
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of RIV4 Versus IIV4 in Pregnant Women
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Safety
  • Adverse Event Following Immunisation
  • Birth Outcomes
Intervention  ICMJE
  • 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
  • Biological: Quadrivalent Inactivated Influenza Vaccine
    Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.
    Other Name: Flulaval
Study Arms  ICMJE
  • Experimental: RIV4
    The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology
    Intervention: Biological: Quadrivalent Recombinant Influenza Vaccine
  • Active Comparator: IIV4
    Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.
    Intervention: Biological: Quadrivalent Inactivated Influenza Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 1, 2021)
383
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
360
Estimated Study Completion Date  ICMJE September 14, 2021
Estimated Primary Completion Date September 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969641
Other Study ID Numbers  ICMJE Pro00101707
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Children's Hospital Medical Center, Cincinnati
  • Boston Medical Center
  • Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Geeta K Swamy, MD Duke University
Principal Investigator: Karen R Broder, MD Centers for Disease Control and Prevention
PRS Account Duke University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP