Overview

This trial is active, not recruiting.

Condition influenza
Treatments inactivated influenza vaccine trivalent types a and b, meningococcal polysaccharide-diphtheria toxoid conjugate vaccine
Phase phase 4
Sponsor University of Maryland
Collaborator Bill and Melinda Gates Foundation
Start date September 2011
End date April 2013
Trial size 4192 participants
Trial identifier NCT01430689, HP-00049582

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.

A substudy was added in December 2014 to test a subset of the nasal/oropharyngeal samples collected from the pregnant women and infants for RSV and pertussis to describe the epidemiologyof infections in this population. Additional testing on stored serum samples from these individuals in an attempt to identify a protective titer of antibody that could protect infants from these infections.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Women will be vaccinated with Influenza vaccine: Inactivated Influenza Vaccine Trivalent Types A and B
inactivated influenza vaccine trivalent types a and b Vaxigrip
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
(Active Comparator)
Women will be vaccinated with IM injection of Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine
meningococcal polysaccharide-diphtheria toxoid conjugate vaccine Menactra - Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Product No. 49281-589-05
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 Outcomes

Measure
Number of infants with influenza whose mothers received vaccine at any time during the 3rd trimester
time frame: 2 years

Secondary Outcomes

Measure
Number of infants with influenza whose mothers received vaccine at least 14 days prior to delivery
time frame: 2 years

Eligibility Criteria

Female participants of any age.

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

Additional Information

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
Principal investigator Milagritos D Tapia, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Maryland.