Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine

Condition(s) targeted: Influenza

Intervention: SIIL LAIV (live, trivalent seasonal influenza vaccine) (Biological); Placebo (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: PATH Vaccine Solutions

Official(s) and/or principal investigator(s):
W. Abdullah Brooks, MD, MPH, Principal Investigator, Affiliation: JHSPH, ICDDR,B

In this Phase II randomized controlled clinical trial, generally healthy male and female children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh. The study is expected to continue for at least 6 months following vaccination. The experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is administered in a 0. 5 ml intranasal dose (one spray of 0. 25 ml per nostril) via a reusable sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in appearance to the active vaccine. The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24 through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among children receiving study vaccine as compared to children receiving placebo.

Official title: Assessment of the Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine Among Children Aged 24 Through 59 Months in Bangladesh

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes

Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes

Percentage of Participants With Unsolicited Adverse Events (AEs)

Percentage of Participants With Solicited Local and Systemic Reactions

Secondary outcome:

The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation

Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.

Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation

Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation

Minimum age: 24 Months. Maximum age: 59 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female child at least 24 months of age and no older than 59 months of

age at the time of study vaccination

- A child whose parent or guardian's primary residence, at the time of study

vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial

- A child whose parent or legal guardian is willing to provide written informed consent

prior to the participant's study vaccination Exclusion Criteria:

- Has any serious chronic disease including progressive neurologic disease,

tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system

- Is receiving immunosuppressive agents including systemic corticosteroids during the

two weeks prior to study vaccination

- Has a history of documented hypersensitivity to eggs or other components of the

vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations

- Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks

before

- Lives in household with somebody currently participating in a respiratory vaccination

or antiviral study

- Has current or past participation (within 2 months of trial enrollment visit) in any

clinical trial involving a drug or biologic with activity against respiratory disease

- Has any condition determined by investigator as likely to interfere with evaluation

of the vaccine or be a significant potential health risk to the child

ICDDR,B Kamalapur, Dhaka, Bangladesh

Starting date: June 2012
Last updated: May 15, 2015