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Completed

NCT Number: NCT01034254

Field Trial of Maternal Influenza Immunization in Asia

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.

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Key information

Conditions

Influenza Human Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Digestive System Diseases Gram-Negative Bacterial Infections Hepatitis Hepatitis E Hepatitis, Viral, Human Infections Influenza, Human Liver Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Whooping Cough

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Medicine, Tribhuvan Univerisity

Kathmandu, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mid to late pregnancy

Exclusion criteria

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

Treatment and study plan

influenza vaccine

Biological

Pregnant women will receive FDA approved influenza vaccine.

Other names: "VAXIGRIP®

Saline placebo

Biological

Vaccination of pregnant women with saline placebo.

Other names: saline

Primary outcomes

  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 outcomes

  1. Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant

    Time frame: 2 annual recruitment cycles

    • To estimate the efficacy of maternal vaccination for producing an immune response in the mother and for passive antibody transfer to the infant.
    • 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.
    • 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

    • To estimate the prevalence of anti-hepatitis E immunoglobulin G in women of reproductive age in rural Nepal.
    • To estimate the incidence of hepatitis E infection (anti-hepatitis E seroconversion) during pregnancy in rural Nepal.
    • To estimate the disease to infection ratio among women who seroconvert.
    • To evaluate biochemical correlates of clinical disease among women who seroconvert.
    • 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Johns Hopkins Bloomberg School of Public Health
  • Seattle Children's Hospital
  • Thrasher Research Fund
  • Tribhuvan University, Nepal

Registry information

Acronym: Mothers'Gift

Important dates

Study start
2010
Primary completion
2014
Study completion
2017
First posted
Dec 17, 2009
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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