A clinical trial to compare the effectiveness of licensed live and inactivated influenza vaccines administered as nasal spray and injection respectively in children.

Phase 4

Completed

• Registration Number: CTRI/2015/06/005902
• Lead Sponsor: Dr Anand Krishnan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3041

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

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:

ochronic disease of any body system

ochronic infections such as tuberculosis

ogenetic disorders, such as Downâ??s syndrome or other cytogenetic disorder

oknown or suspected disease of the immune system

oChronic 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified