Field Trial of Maternal Influenza Immunization in Asia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza Human
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 3693
- Locations
- 1
- Primary Endpoint
- Field Trial of Maternal Influenza Immunization
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •mid to late pregnancy
Exclusion Criteria
- •do not intend to deliver in the study area
- •previous pregnancy in this study
Outcomes
Primary Outcomes
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
- Pertussis In Infants(2 annual rucruiting cycles)
- Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant(2 annual recruitment cycles)
- Substudy #3: Hepatitis E Infection in Pregnancy(2 annual recruiting cycles)
- Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members(2 annual recruiting cycles)