A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine

NCT00873912 | Completed Phase 4 Results

• 1 other identifier: MI-MA205
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.

Conditions

Healthy

Keywords

influenza; FluMist

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F

  The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage points.

  Days 1-8 after vaccination

Secondary Outcomes (4)

• Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)

  Days 1-8 after vaccination

• Number of Participants Reporting Any Solicited Symptom or at Least One AE

  Days 1-15 after vaccination

• Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)

  Days 1-29 after vaccination

• Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)

  Days 1-181 after vaccination

Study Arms (2)

Monovalent influenza virus vaccine

EXPERIMENTAL

Frozen monovalent vaccine containing new strain

Biological: Monovalent influenza virus vaccine

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

Monovalent influenza virus vaccine BIOLOGICAL

Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).

Monovalent influenza virus vaccine

Placebo BIOLOGICAL

Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of investigational product administration
• Healthy by medical history and physical exam
• Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act \[HIPAA\] in the United States of America \[USA\], European Union \[EU\] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), had sterile male partner, were premenarchal or at least 2 years postmenopausal, or practiced abstinence, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for at least 30 days prior to dosing with investigational product, and must have agreed to continue using such precautions for at least 90 days after dosing with investigational product; cessation of birth control after this point was to be discussed with a responsible physician. The subject must also have had a negative serum or urine pregnancy test within 14 days prior to investigational product administration (if screening and administration of investigational product did not occur on the same day) and on the day of investigational product administration prior to randomization
• Males, unless surgically sterile, must have used 2 effective methods of birth control with a female partner and must have agreed to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Day 1 through Day 31 of the study)
• Subject available by telephone
• Ability to understand and comply with the requirements of the protocol, as judged by the investigator
• Ability to complete follow-up period of 180 days after dosing as required by the protocol

You may not qualify if:

• History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life-threatening, or severe reactions to previous influenza vaccinations
• History of hypersensitivity to gentamicin
• Any condition for which the inactivated influenza vaccine was indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
• Acute febrile (\> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
• Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus \[HIV\] infection, or ongoing immunosuppressive therapy
• History of Guillain-Barré syndrome
• A household contact who was severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual required care in a protective environment); subject should additionally have avoided close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
• Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted)
• Expected receipt of anti-pyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
• Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
• Known or suspected mitochondrial encephalomyopathy
• Nursing mother
• Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would have interfered with evaluation of the investigational product or interpretation of subject safety or study results
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Covance CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

Covance CRU, Inc

Portland, Oregon, 97239, United States

Location

Covance CRU, Inc

Austin, Texas, 78757, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Elissa Malkin, DO
• Organization: MedImmune, LLC

malkine@medimmune.com

301-398-0000

Study Officials

• Elissa Malkin, D.O.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 14, 2011
• Results First Posted: July 13, 2011

Record last verified: 2011-07

Locations

US (3)