Field Trial of Maternal Influenza Immunization in Asia (Mothers'Gift)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Seattle Children's Hospital
Tribhuvan University, Nepal
Johns Hopkins Bloomberg School of Public Health
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01034254
First received: December 16, 2009
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.


Condition Intervention Phase
Influenza Human
Biological: influenza vaccine
Biological: saline placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Field Trial of Maternal Influenza Immunization in Asia

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Field Trial of Maternal Influenza Immunization [ Time Frame: 2 annual recruitment cycles coinciding with flu seasons ] [ Designated as safety issue: No ]

    To compare, in women randomized to receive either influenza vaccine or control during pregnancy and their infants (through 6 months of age)

    a) the incidence of influenza-like illness or lab-confirmed influenza episodes b) the distribution of causes of febrile illness and the incidence of clinic visits and hospitalizations c) the incidence of low birth weight, the distribution of birth weight and gestational age and the growth of infants.



Secondary Outcome Measures:
  • Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant [ Time Frame: 2 annual recruitment cycles ] [ Designated as safety issue: No ]
    1. To estimate the efficacy of maternal vaccination for producing an immune response in the mother and for passive antibody transfer to the infant.
    2. To determine if timing of vaccination during pregnancy or other maternal factors such as nutritional status are related to level of antibody transfer to the infant.
    3. To compare neutralizing antibody concentrations in breastmilk of women randomized to receive either influenza vaccine or control during pregnancy.

  • Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members [ Time Frame: 2 annual recruiting cycles ] [ Designated as safety issue: No ]
    Specific Aim: To compare the indirect protection of influenza vaccine on influenza-like and influenza-specific febrile illness rates in families of study women.

  • Substudy #3: Hepatitis E Infection in Pregnancy [ Time Frame: 2 annual recruiting cycles ] [ Designated as safety issue: No ]
    1. To estimate the prevalence of anti-hepatitis E immunoglobulin G in women of reproductive age in rural Nepal.
    2. To estimate the incidence of hepatitis E infection (anti-hepatitis E seroconversion) during pregnancy in rural Nepal.

      1. To estimate the disease to infection ratio among women who seroconvert.
      2. To evaluate biochemical correlates of clinical disease among women who seroconvert.
    3. To describe pregnancy outcomes (miscarriage, stillbirth, neonatal mortality, maternal mortality) associated with women identified with incident infection or acute hepatitis E disease.

  • Pertussis In Infants [ Time Frame: 2 annual rucruiting cycles ] [ Designated as safety issue: No ]
    Estimate the incidence of pertussis in infants under 6 months of age and the protection afforded by maternal antibody transfer to infants.


Estimated Enrollment: 3000
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: influenza vaccine
Pregnant women assigned to the intervention group will receive one dose of seasonal influenza vaccine at the time of enrollment. The vaccine that will be given will be the current seasonal influenza recommended vaccine at the time of enrollment.
Biological: influenza vaccine
Pregnant women will receive FDA approved influenza vaccine.
Other Name: "VAXIGRIP®
Placebo Comparator: saline placebo
Pregnant women assigned to the control group will receive one dose of placebo (normal saline).
Biological: saline placebo
Vaccination of pregnant women with saline placebo.
Other Name: saline

Detailed Description:

This is a community-based, placebo-controlled, individually randomized trial in trial among women who are or who become pregnant in 9 Village Development Committees in Sarlahi District, Nepal. The study population for this trial will include all women who are identified as pregnant with gestational age between 17 and 34 weeks gestation during a 12-month period in 9 Village Development Committees (VDC) of Sarlahi District, Nepal. The 9 VDCs include: Dhungre Khola, Karmaiya, Hariaun, Ghurkauli, Sasapur, Netraganj, Lalbandi, Jabdi, and Raniganj.

The vaccine that will be given will be the most current vaccine at the time of subject enrollment. That is, for women enrolled after October in either study cohort, the vaccine will be switched to the newly available vaccine for that year.

The control group will be placebo (saline injection). The justification for the use of a placebo injection in this trial is as follows: There is only one trial (Bangladesh) that demonstrates efficacy of influenza vaccination in pregnancy on perinatal outcomes and respiratory morbidity in early infancy. One of the issues with that study is that it was not placebo controlled. The "control" in that study was adult pneumococcal vaccine. It could be that the Bangladesh study underestimated the impact of influenza vaccine because the mothers and infants receive some indirect protection from the pneumococcal vaccine. In addition, influenza vaccine is not part of national policy or recommendations in Nepal at the current time and Ministry of Health officials are very interested in the results of our study as they consider their immunization program expansion over the next few years.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mid to late pregnancy

Exclusion Criteria:

  • do not intend to deliver in the study area
  • previous pregnancy in this study
  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: NCT01034254

Contacts
Contact: Mark C Steinhoff, MD 513-636-1376 Mark.Steinhoff@chmc.org

Locations
Nepal
Institute of Medicine, Tribhuvan Univerisity Recruiting
Kathmandu, Nepal
Contact: Prakash S Shrestha, MD    441-2202      
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Bill and Melinda Gates Foundation
Seattle Children's Hospital
Tribhuvan University, Nepal
Johns Hopkins Bloomberg School of Public Health
Thrasher Research Fund
Investigators
Principal Investigator: Mark C Steinhoff, MD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01034254     History of Changes
Other Study ID Numbers: Mothers'Gift 241 Field Trial
Study First Received: December 16, 2009
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board
Nepal: Health Research Council

Keywords provided by Children's Hospital Medical Center, Cincinnati:
influenza
immunization
pregnancy
efficacy
pertussis
hepatitis E

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

ClinicalTrials.gov processed this record on July 28, 2014