Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Maternal Flu Vaccine Trial in Bamako, Mali

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Milagritos Tapia, University of Maryland
ClinicalTrials.gov Identifier:
NCT01430689
First received: September 6, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Inactivated Influenza Vaccine Trivalent Types A and B
Biological: Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Number of infants with influenza whose mothers received vaccine at any time during the 3rd trimester [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • Number of infants with influenza whose mothers received vaccine at least 14 days prior to delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 4192
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaxigrip
Women will be vaccinated with Influenza vaccine: Vaxigrip
Biological: Inactivated Influenza Vaccine Trivalent Types A and B

Pregnant Woman:

- Randomization to receive 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 Name: Vaxigrip - Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)ACT Code J07B B; Control #138119
Active Comparator: Menactra
Women will be vaccinated with Meningococcal Vaccine: Menactra
Biological: Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine

Pregnant women randomized to receive 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 Name: Menactra - Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Product No. 49281-589-05

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430689

Locations
Mali
Centre pour le Developpement des Vaccins - Mali
Bamako, Mali
Sponsors and Collaborators
University of Maryland
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Milagritos D Tapia, MD University of Maryland
Study Director: Myron M Levine, MD, DTPH University of Maryland
Principal Investigator: Samba O Sow, MD Centre pour le Developpement des Vaccins - Mali
  More Information

No publications provided

Responsible Party: Milagritos Tapia, Faculty, University of Maryland
ClinicalTrials.gov Identifier: NCT01430689     History of Changes
Other Study ID Numbers: HP-00049582
Study First Received: September 6, 2011
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Influenza
Pregnancy
Neonates

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014