Influenza Clinical Trial
Official title:
Vaccination of HIV-uninfected Pregnant Women With Trivalent Influenza Vaccine in the Prevention of Influenza Illness During Early Infancy and in Mothers: Randomized Controlled Phase III Trial Evaluating Safety, Immunogenicity and Efficacy
Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women
Acute respiratory illness is a significant contributor to neonatal mortality and the leading
cause of under- 5 childhood mortality particularly during infancy. Infants under 6 months of
age have the highest rate of excess influenza-associated hospitalization in industrialized
countries among paediatric age groups. Determining the contribution of influenza to early
childhood morbidity and mortality in sub-Saharan Africa and the potential to prevent
influenza disease through vaccination may contribute to reducing childhood deaths; since
influenza illness is a vaccine preventable disease for which vaccines are developed, licensed
and available at reasonable cost. Unfortunately, infants at highest risk for serious disease
are those under 6 months of age, for whom trivalent inactivated influenza vaccine (TIV) is
poorly immunogenic and not licensed. As pregnant women also have an increased risk of serious
illness (3.3-5.5 fold for hospitalization for influenza-associated acute cardio-respiratory
illness) from influenza infection, one strategy to prevent the complications of influenza in
pregnant women and young infants is through maternal TIV immunization, which is recommended
by the WHO. This could result in direct protection of the women and protection of the young
infant consequent to transplacental transfer of TIV induced antibody.
Barriers to administration of vaccines during pregnancy including lack of information on
effectiveness and concerns about safety probably explain the virtual non-existent use of TIV
in pregnant women from low-middle income countries. Recently data have become available from
Bangladesh in which the benefit of maternal TIV vaccination was demonstrated by a 63% (95%CI
5 to 85) reduction in laboratory-confirmed influenza illness in infants under 24 weeks of age
in children born to mothers vaccinated with TIV and a 36% reduction in clinical illness in
vaccinated mothers.
Much of the influenza virus-associated morbidity and mortality may be due to the synergistic
lethality of influenza with bacterial pathogens leading to pneumonia as well as other viral
co-infections. Superimposed bacterial infections, especially Streptococcus pneumoniae,
contribute to a large proportion of pneumonia deaths associated with influenza illness during
pandemics.
The overall aim of this project is to evaluate the safety, immunogenicity and efficacy of TIV
vaccination of HIV-uninfected pregnant women in preventing influenza related illness in their
young infants, as well as among the women.
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