A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Adults

MedImmune LLC5 sites in 1 country300 target enrollmentAugust 2009

ConditionsHealthy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Healthy
Sponsor: MedImmune LLC
Enrollment: 300
Locations: 5
Primary Endpoint: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

March 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: Days 1-8

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%

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

Time Frame: Day 1, Day 15

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

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

Time Frame: Day 1, Day 29

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

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

Time Frame: Day 1, Day 57

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

Secondary Outcomes

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)
Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1(Days 1-15)
Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2(Days 29-36)
Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2(Days 29-36)
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2(Days 29-36)
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2(Days 29-43)
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2(Days 29-43)
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2(Days 29-43)
Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1(Days 1-29)
Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1(Days 1-29)
Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2(Days 29-57)
Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2(Days 29-57)
Number of Participants With SAEs Through 180 Days Post Final Dose(Days 1-209)
Number of Participants With NOCDs Through 180 Days Post Final Dose.(Days 1-209)
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(Day 1, Day 15)
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(Day 1, Day 29)
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(Day 1, Day 57)
Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)(Day 1, Day 15)
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)(Day 1, Day 29)
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)(Day 1, Day 57)