This trial is active, not recruiting.

Condition influenza human
Treatments influenza vaccine, saline placebo
Phase phase 3
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator Bill and Melinda Gates Foundation
Start date November 2010
End date December 2017
Trial size 3000 participants
Trial identifier NCT01034254, Mothers'Gift 241 Field Trial


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.

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, investigator)
Primary purpose prevention
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.
influenza vaccine "VAXIGRIP®
Pregnant women will receive FDA approved influenza vaccine.
(Placebo Comparator)
Pregnant women assigned to the control group will receive one dose of placebo (normal saline).
saline placebo saline
Vaccination of pregnant women with saline placebo.

Primary Outcomes

Field Trial of Maternal Influenza Immunization
time frame: 2 annual recruitment cycles coinciding with flu seasons

Secondary Outcomes

Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant
time frame: 2 annual recruitment cycles
Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members
time frame: 2 annual recruiting cycles
Substudy #3: Hepatitis E Infection in Pregnancy
time frame: 2 annual recruiting cycles
Pertussis In Infants
time frame: 2 annual rucruiting cycles

Eligibility Criteria

Female participants from 15 years up to 45 years old.

Inclusion Criteria: - mid to late pregnancy Exclusion Criteria: - do not intend to deliver in the study area - previous pregnancy in this study

Additional Information

Official title Field Trial of Maternal Influenza Immunization in Asia
Principal investigator Mark C Steinhoff, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.