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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01034254
Recruitment Status : Active, not recruiting
First Posted : December 17, 2009
Last Update Posted : March 7, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Human Biological: influenza vaccine Biological: saline placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Field Trial of Maternal Influenza Immunization in Asia
Study Start Date : November 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Field Trial of Maternal Influenza Immunization [ Time Frame: 2 annual recruitment cycles coinciding with flu seasons ]

    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 :
  1. Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant [ Time Frame: 2 annual recruitment cycles ]
    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.

  2. Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members [ Time Frame: 2 annual recruiting cycles ]
    Specific Aim: To compare the indirect protection of influenza vaccine on influenza-like and influenza-specific febrile illness rates in families of study women.

  3. Substudy #3: Hepatitis E Infection in Pregnancy [ Time Frame: 2 annual recruiting cycles ]
    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.

  4. Pertussis In Infants [ Time Frame: 2 annual rucruiting cycles ]
    Estimate the incidence of pertussis in infants under 6 months of age and the protection afforded by maternal antibody transfer to infants.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034254

Institute of Medicine, Tribhuvan Univerisity
Kathmandu, Nepal
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
Principal Investigator: Mark C Steinhoff, MD Children's Hospital Medical Center, Cincinnati
More Information


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01034254     History of Changes
Other Study ID Numbers: Mothers'Gift 241 Field Trial
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

Keywords provided by Children's Hospital Medical Center, Cincinnati:
hepatitis E

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs