A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults

NCT ID: NCT00945893

Last Updated: 2011-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-03-31

Brief Summary

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.

Detailed Description

The primary objective of this study was to assess the safety and descriptive immunogenicity of a monovalent influenza virus vaccine containing a new 6:2 influenza virus reassortant in healthy adults.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MEDI3414 [Influenza A (H1N1) vaccine]

MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Group Type: EXPERIMENTAL

MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]

Intervention Type: BIOLOGICAL

0.5 mL; (intranasal sprayer)

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

(intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)

Interventions

MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]

0.5 mL; (intranasal sprayer)

Intervention Type: BIOLOGICAL

Placebo

(intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)

Intervention Type: OTHER

Other Intervention Names

MEDI3414

Eligibility Criteria

Inclusion Criteria

• Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of randomization
• Healthy by medical history and physical examination
• 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, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, is at least 1 year post menopause, or practices abstinence) must use an effective method 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 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the second dose of investigational product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization.
• Males, unless not sexually active, must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after the second dose of investigational product (from Day 1 through Day 59 of the study)
• Subject is available by telephone
• Subject is able to understand and comply with the requirements of the protocol, as judged by the investigator
• Subject is able to complete follow-up period of 180 days after Dose 2 as required by the protocol

Exclusion Criteria

• History of hypersensitivity to any component of the investigational product including egg or egg protein, gelatin or arginine, or serious, life-threatening, or severe reactions to previous influenza vaccinations
• History of hypersensitivity to gentamicin
• Any condition for which the inactivated influenza vaccine is 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
• History of asthma
• Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
• History of Guillain-Barré syndrome
• A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid 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 second dose of investigational product (use of licensed agents for indications not listed in the package insert is permitted)
• Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of each dose of investigational product
• Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of each dose of investigational product
• Receipt of any nonstudy vaccine within 30 days before or after Dose 1 or expected receipt of any nonstudy vaccine within 30 days before or after Dose 2
• Known or suspected mitochondrial encephalomyopathy
• Subject is pregnant or a nursing mother
• Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• Subject or immediate family member of subject is an employee of the clinical study site or is otherwise in involved with the conduct of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raburn Mallory, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Covance Daytona Beach

Daytona Beach, Florida, United States

Pharmax Research Clinic

Miami, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Countries

United States

References

Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L, Yi T, Jones T, Kemble G, Dubovsky F. Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials. PLoS One. 2010 Oct 29;5(10):e13755. doi: 10.1371/journal.pone.0013755.

Reference Type: DERIVED

PMID: 21060780 (View on PubMed)

Other Identifiers

HHS/ASPR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MI-CP215

Identifier Type: -

Identifier Source: org_study_id