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

NCT00946101 | Completed Phase 4 Results DMC

• 2 other identifiers: MI-CP217HHS/ASPR
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Influenza

Keywords

randomized, double-blind, placebo-controlled

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary 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 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%.

  Days 1- 8

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

  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.

  Day 1, Day 15

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

  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.

  Day 1, Day 29

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

  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.

  Day 1, Day 57

Secondary Outcomes (24)

• Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1

  Days 1-8

• Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1

  Days 1-8

• Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1

  Days 1-8

• Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1

  Days 1-15

• Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1

  Days 1-15

Study Arms (2)

MEDI3414 [Influenza A (H1N1) vaccine]

ACTIVE COMPARATOR

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]

Placebo

PLACEBO COMPARATOR

Placebo - Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer

Biological: Placebo

Interventions

MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] BIOLOGICAL

0.5 mL: (intranasal sprayer)

MEDI3414 [Influenza A (H1N1) vaccine]

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

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, 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

Sponsors & Collaborators

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

Study Sites (16)

Coastal Clinic Research, Inc.

Mobile, Alabama, 36608, United States

Location

Benchmark Research

Sacramento, California, 95816, United States

Location

California Research Foundation

San Diego, California, 92103-6204, United States

Location

Benchmark Research

San Francisco, California, 94102, United States

Location

Kentucky Pediatric Research Center

Bardstown, Kentucky, 40004, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Clinical Research Center of Nevada

Henderson, Nevada, 89105, United States

Location

Rochester Clinical Research Inc.

Rochester, New York, 14069, United States

Location

Primary Physicians Research, Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Benchmark Research Ft. Worth

Fort Worth, Texas, 76135, United States

Location

Benchmark Research San Angelo

San Angelo, Texas, 76904, 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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Elissa Malkin, D.O.
• Organization: MedImmune, LLC an affiliate of AstraZeneca AB

malkine@medimmune.com

301-398-0000

Study Officials

• Elissa Malkin, D.O.

  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

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: August 11, 2011
• Results First Posted: August 11, 2011

Record last verified: 2011-07

Locations

US (16)