Clinical trial NCT01034254: Field Trial of Maternal Influenza Immunization in Asia
Official title: Field Trial of Maternal Influenza Immunization in Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza Human
Keywords: influenza
immunization
pregnancy
efficacy
pertussis
hepatitis E
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Seattle Children's Hospital
name: Tribhuvan University, Nepal
name: Johns Hopkins Bloomberg School of Public Health
name: Thrasher Research Fund
First posted: 2009-12-17
Enrollment: 3693
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* mid to late pregnancy

Exclusion Criteria:

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

Primary outcomes:
measure: Field Trial of Maternal Influenza Immunization
timeFrame: 2 annual recruitment cycles coinciding with flu seasons
Secondary outcomes:
measure: Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant
timeFrame: 2 annual recruitment cycles
measure: Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members
timeFrame: 2 annual recruiting cycles
measure: Substudy #3: Hepatitis E Infection in Pregnancy
timeFrame: 2 annual recruiting cycles
measure: Pertussis In Infants
timeFrame: 2 annual rucruiting cycles
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine, Tribhuvan Univerisity
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mark C Steinhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
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