A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age (MI-CP217)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00946101
First received: July 23, 2009
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Influenza
Biological: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
Biological: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Children

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). [ Time Frame: Days 1- 8 ] [ Designated as safety issue: Yes ]
    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 for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals 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 Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [ Time Frame: Day 1, Day 15 ] [ Designated as safety issue: No ]
    Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.

  • Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [ Time Frame: Day 1, Day 29 ] [ Designated as safety issue: No ]
    Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.

  • Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [ Time Frame: Day 1, Day 57 ] [ Designated as safety issue: No ]
    Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.


Secondary Outcome Measures:
  • Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-8 ] [ Designated as safety issue: Yes ]
    Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.

  • Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-8 ] [ Designated as safety issue: Yes ]
  • Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-8 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-15 ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-15 ] [ Designated as safety issue: Yes ]
  • Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-15 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-36 ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-36 ] [ Designated as safety issue: Yes ]
  • Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-36 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-43 ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-43 ] [ Designated as safety issue: Yes ]
  • Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-43 ] [ Designated as safety issue: Yes ]
  • Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1. [ Time Frame: Days 1-29 ] [ Designated as safety issue: Yes ]
    An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).

  • Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1 [ Time Frame: Days 1-29 ] [ Designated as safety issue: Yes ]
    SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.

  • Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2. [ Time Frame: Days 29-57 ] [ Designated as safety issue: Yes ]
    An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).

  • Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2 [ Time Frame: Days 29-57 ] [ Designated as safety issue: Yes ]
    SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.

  • Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product. [ Time Frame: Days 1-209 ] [ Designated as safety issue: Yes ]
    An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).

  • Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product. [ Time Frame: Days 1-209 ] [ Designated as safety issue: Yes ]
    SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.

  • Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 1, Day 15 ] [ Designated as safety issue: No ]
    All immunogenicity analyses are based on the immunogenicity population.

  • Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 1, Day 29 ] [ Designated as safety issue: No ]
    All immunogenicity analyses are based on the immunogenicity population.

  • Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 1, Day 57 ] [ Designated as safety issue: No ]
    All immunogenicity analyses are based on the immunogenicity population.

  • Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15) [ Time Frame: Day 1, Day 15 ] [ Designated as safety issue: No ]
    All immunogenicity analyses are based on the immunogenicity population.

  • Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29) [ Time Frame: Day 1, Day 29 ] [ Designated as safety issue: No ]
    All immunogenicity analyses are based on the immunogenicity population.

  • Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57) [ Time Frame: Day 1, Day 57 ] [ Designated as safety issue: No ]
    All immunogenicity analyses are based on the immunogenicity population.


Enrollment: 326
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MEDI3414 [Influenza A (H1N1) vaccine]
MEDI3414- 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 influenza virus type A/California/07/2009.
Biological: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
0.5 mL: (intranasal sprayer)
Placebo Comparator: Placebo
Placebo - Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer
Biological: Placebo
Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer

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 children.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 2 to 17 years of age (not yet reached their 18th birthday) at the time of randomization
  • 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 and written informed assent) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
  • Females of child-bearing potential, (ie, unless premenarchal, surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, 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. Investigator judgment is required to assess the childbearing potential of a pre-adolescent or adolescent girl.
  • 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's legal representative available by telephone
  • Subject/subject's legal representative is able 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 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, or in children < 5 years of age, history of recurrent wheezing
  • 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)
  • Use of aspirin or salicylate-containing products within 30 days prior to randomization or expected receipt through 30 days after final vaccination
  • Expected receipt of antipyretic or analgesic medication (non-salicylate-containing) 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
  • Adolescent 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, legal representative, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946101

Locations
United States, Alabama
Coastal Clinic Research, Inc.
Mobile, Alabama, United States, 36608
United States, California
Benchmark Research
Sacramento, California, United States, 95816
California Research Foundation
San Diego, California, United States, 92103-6204
Benchmark Research
San Francisco, California, United States, 94102
United States, Kentucky
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States, 40004
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Missouri
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Nevada
Clinical Research Center of Nevada
Henderson, Nevada, United States, 89105
United States, New York
Rochester Clinical Research Inc.
Rochester, New York, United States, 14069
United States, Pennsylvania
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research Ft. Worth
Ft. Worth, Texas, United States, 76135
Benchmark Research San Angelo
San Angelo, Texas, United States, 76904
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Elissa Malkin, D.O. MedImmune LLC
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elissa Malkin, D.O., MedImmune LLC
ClinicalTrials.gov Identifier: NCT00946101     History of Changes
Other Study ID Numbers: MI-CP217, HHS/ASPR
Study First Received: July 23, 2009
Results First Received: June 9, 2010
Last Updated: July 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
randomized, double-blind, placebo-controlled

ClinicalTrials.gov processed this record on October 21, 2014