Maternal Flu Vaccine Trial in Bamako, Mali

September 24, 2019 updated by: Milagritos Tapia, University of Maryland, Baltimore

Prospective, Randomized, Controlled, Observer-Blind Trial to Measure the Efficacy, Safety and Immunogenicity of Trivalent Inactivated Influenza Vaccine and the Safety and Immunogenicity of Quadrivalent Meningococcal Polysaccharide Diphtheria Conjugate Vaccine in Pregnant Malian Women and Their Infants up to 6 Months of Age

The Center for Vaccine Development - Mali is interested in learning if vaccinating a pregnant woman against influenza will protect her infant against this disease. The investigators know that influenza infection, the "flu", affects pregnant women and their infants in Mali. The illness known as flu is caused by a germ (virus) that is passed easily among people. The flu causes symptoms such as fever, cough, sore throat, runny nose, and body aches. Certain groups of people, such as pregnant women and infants, are at risk for having severe disease when they get the flu. Vaccination against influenza is not routinely available to pregnant women in Mali although it is recommended.

Women who wish to participate will have 5 visits to the clinic and weekly visits to the home to follow the health of the woman and her infant when it is born. The investigators will also ask permission to make weekly visits to all children under 5 years of age to follow their health as it relates to influenza infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, controlled observer-blind trial measuring the efficacy, safety and immunogenicity of TIV and the safety and immunogenicity of MCV in pregnant women and their infants up to 6 months of age. Women will be recruited in the 3rd trimester of pregnancy and vaccinated with either TIV or MCV. Safety assessments of the women will be completed 30 minutes and 1 week after vaccination, at delivery and 3 and 6 months after delivery. Safety assessments of the infants will be completed at birth and at 3 and 6 months of age. Immunogenicity assessments will include blood sampling of women immediately prior to vaccination, 4 weeks post-vaccination, at delivery and 3 and 6 months after delivery; infants will have cord blood collected at birth and peripheral blood collections at 3 and 6 months of age. Visits to ascertain the costs related to ILI and LCI will also be conducted. The majority of activities conducted in this trial are related to efficacy assessments which will continue until the newborn infant is 6 months of age. We will be conducting case detection for LCI via weekly household visits. In addition, hospital-based surveillance for meningococcal disease will be conducted to measure the efficacy of MCV.

Study Type

Interventional

Enrollment (Actual)

4193

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mali
      • Bamako, Mali
        • Centre pour le Developpement des Vaccins - Mali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women in third trimester of pregnancy (≥ 28 weeks gestational age based upon last menstrual period, ultrasound or uterine height).
  2. Subject is able to understand and comply with planned study procedures.
  3. Subject has provided written informed consent prior to initiation of any study procedures.
  4. Subject intends to reside in the study area until her newborn infant is 6 months of age.

Exclusion Criteria:

  1. Member of a household which already has a woman who is participating or has participated in this study
  2. History of severe reactions following previous immunization with influenza or meningococcal vaccines
  3. History of Guillain-Barré Syndrome
  4. Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of Vaxigrip and Menactra
  5. Known chronic medical condition that in the judgment of the investigator could compromise the evaluation of the study vaccine or puts the subject at risk
  6. Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  7. Any of the following complications with the ongoing pregnancy: preterm labor (with cervical change), placental abruption, premature rupture of membranes, known major congenital anomaly, or preeclampsia.
  8. Acute illness and/or an oral temperature greater than or equal to 37.8 degrees C, within 72 hours of vaccination (This may result in a temporary delay of vaccination)
  9. Receipt of any other vaccine, excluding tetanus toxoid, within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines and meningococcal A conjugate vaccine (MenAfriVac)) prior to vaccination in this study
  10. Woman who intends to travel out of the study area for the 40 days after delivery
  11. Receipt of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines
  12. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to administration of study vaccines (including systemic corticosteroids, e.g. prednisone or equivalent > 0.5 mg/kg/day; topical and inhaled steroids are allowed)
  13. Any condition which in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the evaluation of the study vaccines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Inactivated Influenza Vaccine Trivalent Types A and B
Women will be vaccinated with Influenza vaccine: Inactivated Influenza Vaccine Trivalent Types A and B
Biological: Inactivated Influenza Vaccine Trivalent Types A and B

Pregnant Woman: Randomization to receive IM injection of Vaxigrip Influenza Vaccine once

Household and Woman/Infant surveillance

  • Home visits weekly until the infant is born and reaches 6 months of age
  • If the woman, her infant or other household contact has signs and symptoms consistent with Influenza Like Illness (ILI)a nasal and oropharyngeal swab will be obtained
Other Names:
  • Vaxigrip
ACTIVE_COMPARATOR: Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate
Women will be vaccinated with IM injection of Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine
Biological: Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine

Pregnant Women - Randomized to receive IM injection of Menactra once

Household and Woman/Infant surveillance

  • Home visits weekly until the infant is born and reaches 6 months of age
  • If the woman, her infant or other household contact has signs and symptoms consistent with Influenza Like Illness (ILI)a nasal and oropharyngeal swab will be obtained
Other Names:
  • Menactra - Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Product No. 49281-589-05

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of infants with influenza whose mothers received vaccine at any time during the 3rd trimester
Time Frame: 2 years
To compare the incidence of laboratory-confirmed influenza (LCI) among infants up to 6 months of age born to mothers immunized with trivalent influenza vaccine (TIV) during the 3rd trimester of pregnancy versus infants born to mothers who received meningococcal conjugate vaccine (MCV) during the 3rd trimester of pregnancy (intention-to-treat (ITT) comparison)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of infants with influenza whose mothers received vaccine at least 14 days prior to delivery
Time Frame: 2 years
To compare the incidence of Laboratory Confirmed Influenza among infants up to 6 months of age born to mothers immunized with TIV during the 3rd trimester of pregnancy versus infants born to mothers who received MCV during the 3rd trimester of pregnancy, for infants born to women immunized ≥ 14 days prior to delivery.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Study Director: Myron M Levine, MD, DTPH, University of Maryland, College Park
  • Principal Investigator: Samba O Sow, MD, Centre pour le Developpement des Vaccins - Mali

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2011

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (ESTIMATE)

September 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00049582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Inactivated Influenza Vaccine Trivalent Types A and B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe