Influenza Vaccine Trial in HIV Uninfected Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and
      efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women
    

Detailed description: 
      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.
    

Intervention name(s): Trivalent influenza vaccine; Normal saline
Intervention type(s): Biological; Biological
Intervention description(s): single dose of 0.5ml of Trivalent influenza vaccine for season will be administered into deltoid muscle of non-dominant arm; Single dose of 0.5ml of normal saline will be administered into deltoid muscle of non-dominant arm
Other intervention name(s): Vaxigrip; NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention