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Maternal Flu Vaccine Trial in Bamako, Mali

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

Mali

Study Type

Interventional

Intervention

Inactivated Influenza Vaccine Trivalent Types A and B

Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Pregnancy, Neonates

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Member of a household which already has a woman who is participating or has participated in this study
History of severe reactions following previous immunization with influenza or meningococcal vaccines
History of Guillain-Barré Syndrome
Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of Vaxigrip and Menactra
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
Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
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.
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)
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
Woman who intends to travel out of the study area for the 40 days after delivery
Receipt of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines
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)
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

Sites / Locations

Centre pour le Developpement des Vaccins - Mali

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inactivated Influenza Vaccine Trivalent Types A and B

Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate

Arm Description

Women will be vaccinated with Influenza vaccine: Inactivated Influenza Vaccine Trivalent Types A and B

Women will be vaccinated with IM injection of Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine

Outcomes

Primary Outcome Measures

Number of infants with influenza whose mothers received vaccine at any time during the 3rd trimester

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

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.

Full Information

NCT ID

NCT01430689

First Posted

September 6, 2011

Last Updated

September 24, 2019

Sponsor

University of Maryland, Baltimore

Collaborators

Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01430689

Brief Title

Maternal Flu Vaccine Trial in Bamako, Mali

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

September 12, 2011 (Actual)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

Collaborators

Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Pregnancy, Neonates

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

4193 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inactivated Influenza Vaccine Trivalent Types A and B

Arm Type

Experimental

Arm Description

Women will be vaccinated with Influenza vaccine: Inactivated Influenza Vaccine Trivalent Types A and B

Arm Title

Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate

Arm Type

Active Comparator

Arm Description

Women will be vaccinated with IM injection of Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine

Intervention Type

Biological

Intervention Name(s)

Inactivated Influenza Vaccine Trivalent Types A and B

Other Intervention Name(s)

Vaxigrip

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine

Other Intervention Name(s)

Menactra - Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Product No. 49281-589-05

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of infants with influenza whose mothers received vaccine at any time during the 3rd trimester

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of infants with influenza whose mothers received vaccine at least 14 days prior to delivery

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women in third trimester of pregnancy (≥ 28 weeks gestational age based upon last menstrual period, ultrasound or uterine height). Subject is able to understand and comply with planned study procedures. Subject has provided written informed consent prior to initiation of any study procedures. Subject intends to reside in the study area until her newborn infant is 6 months of age. Exclusion Criteria: Member of a household which already has a woman who is participating or has participated in this study History of severe reactions following previous immunization with influenza or meningococcal vaccines History of Guillain-Barré Syndrome Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of Vaxigrip and Menactra 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 Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 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. 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) 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 Woman who intends to travel out of the study area for the 40 days after delivery Receipt of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Milagritos D Tapia, MD

Organizational Affiliation

University of Maryland, College Park

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Myron M Levine, MD, DTPH

Organizational Affiliation

University of Maryland, College Park

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Samba O Sow, MD

Organizational Affiliation

Centre pour le Developpement des Vaccins - Mali

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre pour le Developpement des Vaccins - Mali

City

Bamako

Country

Mali

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32868130

Citation

Amin AB, Nunes MC, Tapia MD, Madhi SA, Cutland CL, Wairagkar N, Omer SB; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Immunogenicity of influenza vaccines administered to pregnant women in randomized clinical trials in Mali and South Africa. Vaccine. 2020 Sep 22;38(41):6478-6483. doi: 10.1016/j.vaccine.2020.07.020. Epub 2020 Aug 29.

Results Reference

derived

PubMed Identifier

32526188

Citation

Omer SB, Clark DR, Madhi SA, Tapia MD, Nunes MC, Cutland CL, Simoes EAF, Aqil AR, Katz J, Tielsch JM, Steinhoff MC, Wairagkar N; BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials. Lancet Respir Med. 2020 Jun;8(6):597-608. doi: 10.1016/S2213-2600(19)30479-5.

Results Reference

derived

PubMed Identifier

32379201

Citation

Clark DR, Omer SB, Tapia MD, Nunes MC, Cutland CL, Tielsch JM, Wairagkar N, Madhi SA; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Influenza or Meningococcal Immunization During Pregnancy and Mortality in Women and Infants: A Pooled Analysis of Randomized Controlled Trials. Pediatr Infect Dis J. 2020 Jul;39(7):641-644. doi: 10.1097/INF.0000000000002629.

Results Reference

derived

PubMed Identifier

29443825

Citation

Omer SB, Clark DR, Aqil AR, Tapia MD, Nunes MC, Kozuki N, Steinhoff MC, Madhi SA, Wairagkar N; for BMGF Supported Maternal Influenza Immunization Trials Investigators Group. Maternal Influenza Immunization and Prevention of Severe Clinical Pneumonia in Young Infants: Analysis of Randomized Controlled Trials Conducted in Nepal, Mali and South Africa. Pediatr Infect Dis J. 2018 May;37(5):436-440. doi: 10.1097/INF.0000000000001914.

Results Reference

derived

PubMed Identifier

27261067

Citation

Tapia MD, Sow SO, Tamboura B, Teguete I, Pasetti MF, Kodio M, Onwuchekwa U, Tennant SM, Blackwelder WC, Coulibaly F, Traore A, Keita AM, Haidara FC, Diallo F, Doumbia M, Sanogo D, DeMatt E, Schluterman NH, Buchwald A, Kotloff KL, Chen WH, Orenstein EW, Orenstein LAV, Villanueva J, Bresee J, Treanor J, Levine MM. Maternal immunisation with trivalent inactivated influenza vaccine for prevention of influenza in infants in Mali: a prospective, active-controlled, observer-blind, randomised phase 4 trial. Lancet Infect Dis. 2016 Sep;16(9):1026-1035. doi: 10.1016/S1473-3099(16)30054-8. Epub 2016 May 31.

Results Reference

derived

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Maternal Flu Vaccine Trial in Bamako, Mali

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