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

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ClinicalTrials.gov Identifier: NCT01034254
Recruitment Status : Unknown
Verified March 2016 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2009
Last Update Posted : March 7, 2016
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

Tracking Information
First Submitted Date  ICMJE December 16, 2009
First Posted Date  ICMJE December 17, 2009
Last Update Posted Date March 7, 2016
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
The incidence of influenza and influenza-like febrile illness episodes among pregnant women and their newborn infants in women randomized to receive either influenza vaccine or control during pregnancy. [ Time Frame: 2 annual recruitment cycles coinciding with flu seasons ]
Change History Complete list of historical versions of study NCT01034254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
  • To compare the distribution of cause of febrile illness in pregnant/lactating study women and their infants. [ Time Frame: 2 annual recruitment cycles ]
  • To compare the indirect protection of influenza vaccine on influenza-like and influenza-specific febrile illness rates in families of study women. [ Time Frame: 2 annual recruiting cycles ]
  • To assess the passive transfer of influenza-specific antibody from mother to infant among study women. [ Time Frame: 2 annual recruiting cycles ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Field Trial of Maternal Influenza Immunization in Asia
Official Title  ICMJE Field Trial of Maternal Influenza Immunization in Asia
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.
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 Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Influenza Human
Intervention  ICMJE
  • Biological: influenza vaccine
    Pregnant women will receive FDA approved influenza vaccine.
    Other Name: "VAXIGRIP®
  • Biological: saline placebo
    Vaccination of pregnant women with saline placebo.
    Other Name: saline
Study Arms
  • 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.
    Intervention: Biological: influenza vaccine
  • Placebo Comparator: saline placebo
    Pregnant women assigned to the control group will receive one dose of placebo (normal saline).
    Intervention: Biological: saline placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2010)
3000
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2009)
5600
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • mid to late pregnancy

Exclusion Criteria:

  • do not intend to deliver in the study area
  • previous pregnancy in this study
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01034254
Other Study ID Numbers  ICMJE Mothers'Gift 241 Field Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: To be determined
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Seattle Children's Hospital
  • Tribhuvan University, Nepal
  • Johns Hopkins Bloomberg School of Public Health
  • Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Mark C Steinhoff, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP