None listed
Conditions
Interventions
Intervention1: Live Attenuated Influenza Vaccine(LAIV) Southern Hemisphere: Dose & strength: children 2-10 years: 0.5 ml
Number of Doses: 1 dose for children 2-10 years of age
Intervention2: Inactiv
Sponsors
Dr Anand Krishnan
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria before enrollment and randomization: • Aged 2-10 years • Resident of one of the study villages (â??Residentâ?? defined as sleeping in the house at least 6 months of the current calendar year) • Agrees to follow-up through weekly household visits • Parent/guardian provides informed consent • Children aged above 7 years will provide written assent and those below 7 years will provide verbal assent
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they meet any of the following criteria: • Prior receipt of influenza vaccine for the study season • Any serious, active, medical conditions, including: o chronic disease of any body system o chronic infections such as tuberculosis o genetic disorders, such as Downâ??s syndrome or other cytogenetic disorder o known or suspected disease of the immune system o Chronic or active wheezing illness • Received immunosuppressive agents including systemic corticosteroids during the month prior to study vaccination. • Less than 5 years who have a history of recurrent wheezing • Children receiving concomitant aspirin • History of Guillain-Barré Syndrome that occurred after receiving influenza vaccine in the past • History of allergy to chicken eggs or who are allergic to any of the vaccine ingredients like gelatin. • Current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving any investigational products. • History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. • Any condition determined by investigator as likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study. Temporary exclusion criteria: • Administration of another live vaccine in the month prior to vaccination • Nasal congestion that limits delivery of the vaccine to the nasal lining. • Acute illness accompanied by a body temperature of 37.5°C or above (axillary measurement) • Any acute respiratory infection within 14 days of enrollment visit. • Any illness accompanied by active wheezing within 14 days of enrollment visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Incidence of laboratory confirmed influenza virus infection among children receiving two different influenzavaccines and between children receiving vaccine and controlTimepoint: Difference in Incidence of laboratory confirmed influenza virus infection among children receiving two different influenzavaccines and between children receiving vaccine and control | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the safety profile of live-attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) including immediate, local or systemic reactogenicity, and any systemic or serious adverse events among vaccinated children, as well as long-term wheezing outcomes.Timepoint: Incidence of adverse effects following Vaccination: First 1 hour , Day 2 , 1 week and 1 month following vaccination Time points: one year | — |
Countries
India
Contacts
Public ContactDr Anand Krishnan
All India Institute of Medical Sciences(AIIMS)
Outcome results
None listed