A Phase 3 interventional study of influenza vaccine and saline placebo in Influenza Human, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in Nepal. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-01.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 3, Interventional, and Prevention
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.
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.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 3,693 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
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Exclusion Criteria:
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.
Biological: influenza vaccine
Pregnant women assigned to the control group will receive one dose of placebo (normal saline).
Biological: saline placebo
Pregnant women will receive FDA approved influenza vaccine.
Also known as: "VAXIGRIP®
Vaccination of pregnant women with saline placebo.
Also known as: saline
Field Trial of Maternal Influenza Immunization
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.
Time frame: 2 annual recruitment cycles coinciding with flu seasons
Substudy #1: Transplacental Transfer of Influenza Antibody from Mother to Infant
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.
Time frame: 2 annual recruitment cycles
Substudy #2: Indirect Protection of Maternal Influenza Vaccination on Family Members
Specific Aim: 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
Substudy #3: Hepatitis E Infection in Pregnancy
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.
Time frame: 2 annual recruiting cycles
Pertussis In Infants
Estimate the incidence of pertussis in infants under 6 months of age and the protection afforded by maternal antibody transfer to infants.
Time frame: 2 annual rucruiting cycles
Plan to share: Undecided — To be determined
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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