Clinical trial NCT00945893: A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2009-07-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).
timeFrame: Days 1-8
measure: Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
timeFrame: Day 1, Day 15
measure: Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
timeFrame: Day 1, Day 29
measure: Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
timeFrame: Day 1, Day 57
Secondary outcomes:
measure: Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1
timeFrame: Days 1-8
measure: Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1
timeFrame: Days 1-8
measure: Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.
timeFrame: Days 1-8
measure: Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1
timeFrame: Days 1-15
measure: Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1
timeFrame: Days 1-15
measure: Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1
timeFrame: Days 1-15
measure: Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2
timeFrame: Days 29-36
measure: Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2
timeFrame: Days 29-36
measure: Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2
timeFrame: Days 29-36
measure: Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2
timeFrame: Days 29-43
measure: Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2
timeFrame: Days 29-43
measure: Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2
timeFrame: Days 29-43
measure: Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1
timeFrame: Days 1-29
measure: Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1
timeFrame: Days 1-29
measure: Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2
timeFrame: Days 29-57
measure: Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2
timeFrame: Days 29-57
measure: Number of Participants With SAEs Through 180 Days Post Final Dose
timeFrame: Days 1-209
measure: Number of Participants With NOCDs Through 180 Days Post Final Dose.
timeFrame: Days 1-209
measure: Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
timeFrame: Day 1, Day 15
measure: Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus
timeFrame: Day 1, Day 29
measure: Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
timeFrame: Day 1, Day 57
measure: Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)
timeFrame: Day 1, Day 15
measure: Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)
timeFrame: Day 1, Day 29
measure: Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)
timeFrame: Day 1, Day 57
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Daytona Beach
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
Study officials:
affiliation: MedImmune LLC
name: Raburn Mallory, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.