A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial
      of the clinical efficacy of trivalent Serum Institute of India, Ltd. (SIIL)live-attenuated
      influenza vaccine (LAIV) vaccine among children aged 24 through 59 months in Bangladesh.

      Background:

        1. Burden: Within Bangladesh, community- based influenza surveillance identified 84.5
           cases/1000 children-years among children <5 years, while 10% of clinical pneumonia cases
           were influenza positive in this age group.

        2. Knowledge gap: There has never been a randomized clinical efficacy trial of the SIIL
           LAIV vaccine conducted among children in a low-income country.

        3. Relevance: Another LAIV vaccine (made by MedImmune) has been shown to have high efficacy
           against laboratory-confirmed influenza among children. The SIIL LAIV has the potential
           to be an inexpensive intervention to prevent pediatric influenza disease.

      Primary Hypothesis: In children aged 24 through 59 months in Bangladesh, LAIV is efficacious
      in reducing rates of symptomatic, laboratory-confirmed influenza (vaccine-matched strains)
      among children vaccinated with LAIV as compared to children vaccinated with a placebo through
      the first influenza season following vaccination.

      Primary Objective: To determine the efficacy of LAIV in reducing rates of symptomatic,
      laboratory-confirmed influenza virus infection (vaccine-matched strains) among children
      receiving LAIV as compared to children receiving a placebo through the first influenza season
      following vaccination (through December 2013).

      Methods: A total of 1761 children will be enrolled and randomized in a 2:1 ratio of LAIV to
      placebo beginning in March 2013. After vaccination, all children will be evaluated for
      reactions with one home visit four days post vaccination. Subsequently, all children will be
      monitored weekly for safety outcomes and illness signs at weekly field worker home visits
      through December 2013. An extended surveillance period was added to this study and, for
      participants consenting to additional follow-up, surveillance will extend through a second
      season (through September 2014). Participants with illness signs will be referred to the
      study clinic for evaluation using standardized diagnostic criteria and treatment by a study
      physician. Children meeting protocol-defined clinical Specimen Collection Criteria will have
      a nasopharyngeal wash specimen collected. Clinical specimens will be tested by Real time
      polymerase chain reaction (rRT-PCR) for evidence of influenza virus infection.

      Primary Outcome measures/variables: Vaccine efficacy will be assessed against symptomatic,
      laboratory-confirmed influenza for all circulating virus strains.
    


Intervention name(s): SIIL Live Attenuated Influenza Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A single dose of SIIL Trivalent LAIV--2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010; A single dose of inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention