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Trial record 34 of 112 for:    mf59

Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

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ClinicalTrials.gov Identifier: NCT02680002
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Biomedical Advanced Research and Development Authority

Tracking Information
First Submitted Date  ICMJE January 26, 2016
First Posted Date  ICMJE February 11, 2016
Last Update Posted Date August 22, 2017
Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Number of occurences of mild, moderate, or severe solicited local and systemic reactogenicity symptoms [ Time Frame: Days 0 up to Day 42 ]
    Occurence of mild, moderate, or severe solicited local and systemic reactogenicity symptoms
  • Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody [ Time Frame: 21 days after receipt of second dose of vaccine (Day 42) ]
    Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02680002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Occurence of vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) [ Time Frame: first vaccination through 13 months ]
    Occurence of vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal
  • Frequency and severity of unsolicited adverse events (AE) [ Time Frame: 21 days following each vaccination (Days 0-21; Days 21-42) ]
    Frequency and severity of unsolicited adverse events (AE) for 21 days following each vaccination
  • Occurrence of clinical safety laboratory AEs [ Time Frame: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42) ]
    Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
  • GMT of serum microneutralization (MN) antibodies [ Time Frame: Days 0, 21, 28, 42, and 201 ]
  • Serum HAI titer of at least 1:40 [ Time Frame: Days 0, 21, 28, 42, and 201 ]
    Proportion of subjects achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
  • Seroconversion rate (SCR) [ Time Frame: Days 21, 28, 42, and 201 ]
    Defined as proportion of subjects achieving either a prevaccination HAI or MN titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI or MN titer of at least 1:10 and a 4-fold or greater increase of HAI or MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI or MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection
  • Occurrence of vital sign abnormalities [ Time Frame: 30 minutes post-vaccination on Day 1 and Day 21 ]
  • GMT of serum HAI antibodies [ Time Frame: Days 0, 21, 28, and 201 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Official Title  ICMJE Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant
Brief Summary The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.
Detailed Description This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored >10 years) and adjuvant (ie, stored >5 years).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE A/Vietnam/H5N1 Influenza Virus
Intervention  ICMJE
  • Biological: 7.5 mcg H5N1 (stored as monobulk)
  • Biological: 15 mcg H5N1 (stored as monobulk)
  • Biological: 90 mcg H5N1 (stored as monobulk)
  • Biological: 90 mcg H5N1 (stored in vials)
  • Other: MF59
  • Other: MF59 (stored as monobulk)
Study Arms  ICMJE
  • Experimental: 7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)
    Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated
    Interventions:
    • Biological: 7.5 mcg H5N1 (stored as monobulk)
    • Other: MF59 (stored as monobulk)
  • Experimental: 15 mcg H5N1 (monobulk) Plus MF59 (monobulk)
    Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant
    Interventions:
    • Biological: 15 mcg H5N1 (stored as monobulk)
    • Other: MF59 (stored as monobulk)
  • Experimental: 7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
    Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
    Interventions:
    • Biological: 7.5 mcg H5N1 (stored as monobulk)
    • Other: MF59
  • Experimental: 15 mcg H5N1 (monobulk) Plus MF59 (vials)
    Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant
    Interventions:
    • Biological: 15 mcg H5N1 (stored as monobulk)
    • Other: MF59
  • Experimental: 90 mcg H5N1 (monobulk) without MF59
    Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
    Intervention: Biological: 90 mcg H5N1 (stored as monobulk)
  • Experimental: 90 mcg H5N1 (vials) without MF59
    Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
    Intervention: Biological: 90 mcg H5N1 (stored in vials)
Publications * Oshansky CM, Zhou J, Gao Y, Schweinle JE, Biscardi K, DeBeauchamp J, Pavetto C, Wollish A; BRITE Study Coordination Team, Webby RJ, Cioce V, Donis RO, Bright RA. Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). Vaccine. 2019 Jan 14;37(3):435-443. doi: 10.1016/j.vaccine.2018.11.069. Epub 2018 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2017)
422
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
420
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or nonpregnant female
  • Provide written informed consent prior to study-related procedures
  • Stable health status
  • Access to consistent and reliable means of telephone contact
  • Able to understand and comply with planned study procedures
  • Agree to stay in contact with site, and no plans to move from study area for study duration

Exclusion Criteria:

  • Allergic to eggs, other vaccine components, or squalene-based adjuvants
  • Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
  • Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
  • Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
  • Have an active neoplastic disease or history of hematologic malignancy
  • Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose inhaled steroids (>800 mcg/day) within preceding 6 months
  • Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
  • Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02680002
Other Study ID Numbers  ICMJE BARDA CSN 15-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The study results will be posted on publicly available clinical trial registers.
Responsible Party Biomedical Advanced Research and Development Authority
Study Sponsor  ICMJE Biomedical Advanced Research and Development Authority
Collaborators  ICMJE PPD
Investigators  ICMJE Not Provided
PRS Account Biomedical Advanced Research and Development Authority
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP