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

NCT00945893 | Completed Phase 4 Results DMC

• 2 other identifiers: MI-CP215HHS/ASPR
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).

  The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses • H0 (null): rate difference ≥ 10% • HA (alternative): rate difference \< 10%

  Days 1-8

• Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

  Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population.

  Day 1, Day 15

• Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

  Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.

  Day 1, Day 29

• Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

  Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.

  Day 1, Day 57

Secondary Outcomes (24)

• Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1

  Days 1-8

• Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1

  Days 1-8

• Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.

  Days 1-8

• Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1

  Days 1-15

• Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1

  Days 1-15

Study Arms (2)

MEDI3414 [Influenza A (H1N1) vaccine]

EXPERIMENTAL

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.

Biological: MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] BIOLOGICAL

0.5 mL; (intranasal sprayer)

Also known as: MEDI3414

MEDI3414 [Influenza A (H1N1) vaccine]

Placebo OTHER

(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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead
• Department of Health and Human Services: collaborator

Study Sites (5)

Covance Daytona Beach

Daytona Beach, Florida, 30060, United States

Location

Pharmax Research Clinic

Miami, Florida, 33126, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 21060780 DERIVED

Results Point of Contact

• Title: Raburn Mallory, MD Senior Director Clinical Development
• Organization: MedImmune, LLC

malloryr@medimmune.com

301-398-0000

Study Officials

• Raburn Mallory, M.D.

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: September 12, 2011
• Results First Posted: September 5, 2011

Record last verified: 2011-09

Locations

US (5)