Safety of RIV4 Versus IIV4 in Pregnant Women

NCT ID: NCT03969641

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2021-09-29

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.

Conditions

Safety; Adverse Event Following Immunisation; Birth Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

RIV4

The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology

Group Type: EXPERIMENTAL

Quadrivalent Recombinant Influenza Vaccine

Intervention Type: BIOLOGICAL

The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology

IIV4

Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.

Group Type: ACTIVE_COMPARATOR

Quadrivalent Inactivated Influenza Vaccine

Intervention Type: BIOLOGICAL

Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.

Interventions

Quadrivalent Recombinant Influenza Vaccine

The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology

Intervention Type: BIOLOGICAL

Quadrivalent Inactivated Influenza Vaccine

Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.

Intervention Type: BIOLOGICAL

Other Intervention Names

Flublok Quadrivalent; Flulaval

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geeta K Swamy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Karen R Broder, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

Boston Medical Center

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00101707

Identifier Type: -

Identifier Source: org_study_id