A Study to Evaluate the Shedding and Safety of trivalent influenza virus vaccine live, intranasal in infants and young children

Study identifier:MI-CP129

ClinicalTrials.gov identifier:NCT00344305

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Open-Label, Single Arm Trial to Evaluate the Shedding and Safety of CAIV-T Administered to Children 6 to less than 60 Months of Age

Medical condition

Healthy

Phase

Phase 2

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

200

Study type

Interventional

Age

6 Months - 59 Months

Date

Study Start Date: 01 May 2006

Primary Completion Date: 01 Jul 2006

Study Completion Date: 01 Dec 2006

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2017 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female, 6 months to less than 60 months of age (reached their 6th month but not yet reached their 5th year birthday) at the time of study vaccination
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the participants parent/legal representative
- Ability of the participants parent/legal representative to understand and comply with the
requirements of the study
- Participants parent/legal representative available by telephone
- Ability to complete follow-up period of 180 days after study vaccination as required by the
protocol

Exclusion Criteria

- History of hypersensitivity to any component of trivalent influenza virus vaccine live, intranasal, including egg or egg products,
monosodium glutamate, or porcine gelatin
- History of hypersensitivity to gentamicin
- History of Guillain-Barré syndrome
- Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to study vaccination (i.e., children with recent persistent asthma were excluded); or history of severe persistent asthma according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report
- Acute febrile (greater than or equal to [>=] 100.0 degree Fahrenheit [°F] oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to study vaccination
- Any known immunosuppressive condition or immune deficiency disease (including human immunodeficiency virus [HIV] infection), or ongoing receipt of any immunosuppressive therapy
- Household contact who was immunocompromised (participants were also to avoid close contact with immunocompromised individuals for at least 21 days after study vaccination)
- Use of aspirin or aspirin-containing products within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination
- Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Use of any intranasal medication within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Administration of any live virus vaccine within the 30 days prior to study vaccination, or expected receipt through 30 days after study vaccination
- Administration of any inactivated (i.e., non-live) vaccine within the 14 days prior to study vaccination, or expected receipt through 14 days after study vaccination
- Receipt of any investigational agent within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert was permitted)
- Receipt of any blood product within the 90 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Family member or household contact who was an employee of the research center or otherwise involved with the conduct of the study
- Any condition that in the opinion of the investigator would have interfered with evaluation of the vaccine or interpretation of study results

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1: Participants Between 6 to < 24 Months Age Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).	Biological/Vaccine: Trivalent influenza virus vaccine live, intranasal A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains. Other Name: FluMist Other Name: Cold-adapted influenza virus vaccine, trivalent (CAIV-T) Other Name: Live attenuated influenza virus (LAIV)
Experimental: Cohort 2: Participants Between 24 to < 60 Months Age Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).	Biological/Vaccine: Trivalent influenza virus vaccine live, intranasal A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains. Other Name: FluMist Other Name: Cold-adapted influenza virus vaccine, trivalent (CAIV-T) Other Name: Live attenuated influenza virus (LAIV)

Arms

Assigned Interventions

Experimental: Cohort 1: Participants Between 6 to < 24 Months Age
Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

Biological/Vaccine: Trivalent influenza virus vaccine live, intranasal
A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.

Other Name: FluMist

Other Name: Cold-adapted influenza virus vaccine, trivalent (CAIV-T)

Other Name: Live attenuated influenza virus (LAIV)

Experimental: Cohort 2: Participants Between 24 to < 60 Months Age
Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

Other Name: FluMist

Other Name: Cold-adapted influenza virus vaccine, trivalent (CAIV-T)

Other Name: Live attenuated influenza virus (LAIV)

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Michele Jordan

301-398-0000

[email protected]

Investigators

Principal Investigator

Raburn Mallory

MedImmune LLC, an affiliate of AstraZeneca AB