Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    grc85
Previous Study | Return to List | Next Study

Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546192
Recruitment Status : Completed
First Posted : June 6, 2018
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 6, 2018
Results First Submitted Date  ICMJE July 6, 2018
Results First Posted Date  ICMJE August 1, 2018
Last Update Posted Date August 1, 2018
Study Start Date  ICMJE June 17, 2015
Actual Primary Completion Date July 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) [ Time Frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination) ]
    Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer >=40 (1/dilution [dil]) at pre-vaccination and post-vaccination.
  • Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) [ Time Frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination) ]
    Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.
  • Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies [ Time Frame: Day 0 (pre-vaccination), Day 21 (Post-vaccination) ]
    Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.
  • Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens [ Time Frame: 21 days post-vaccination ]
    Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and a post-vaccination titer >= 40 (1/dil). Significant increase was defined as a pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.
  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions [ Time Frame: Within 7 days after vaccination ]
    A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: >=25 mm to <= 50 mm, Grade 2: >=51 to <=100 mm, Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius (°C) to <=38.4°C, Grade 2: >=38.5°C to <=38.9 °C, Grade 3: >= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
  • Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance [ Time Frame: Within 3 days after vaccination ]
    Solicited reactions listed in the CHMP note for guidance included: injection site induration >= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature > 38.0°C for at least one day, malaise, and shivering.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
  • Number of participants with seroprotection [ Time Frame: 21 days after vaccination ]
    Seroprotection was defined as influenza virus antibody titers ≥ 40. EMA requirement was antibody titers ≥ 40 in > 70% of participants aged 18 to 60 years and > 60% in participants aged 61 years or older
  • Number of participants with geometric mean titer ratio (GMTR) > 2.5 [ Time Frame: 21 days after vaccination ]
    EMA requirement was antibody titer ratio above 2.5 for participants aged 18 to 60 years and above 2 for participants aged 61 years or older
  • Number of participants with seroconversion or significant increase [ Time Frame: 21 days after vaccination ]
    Seroconversion was defined as pre-vaccination titer < 10 (1/dil) increase of titer to post-vaccination titer >= 40 (1/dil). Significant increase was defined as pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase of the titer. EMA requirement was seroconversion in > 40% of participants aged 18 to 60 years and > 30% of participants aged 61 years or older
  • Geometric mean titers (GMTs) [ Time Frame: 21 days after vaccination ]
    Antibody titer expressed as geometric mean titer
  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions [ Time Frame: Within 7 days after vaccination ]
    Injection site reactions: pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, headache, malaise, myalgia, and shivering
  • Number of participants reporting reactions listed in the EMA guidelines [ Time Frame: Within 3 days after vaccination ]
    Occurrence of the following reactions as defined by the EMA guidelines (Committee for Medicinal Products for Human Use, Note for Guidance CPMP/BWP/214/96): injection site induration ≥ 50 mm and persisting for at least 4 consecutive days, injection site ecchymosis, temperature > 38°C for 24 hours or more, malaise, and shivering
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
Official Title  ICMJE Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)
Brief Summary

The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older.

The objectives were:

  • To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96
  • To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
  • To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
Detailed Description

All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine at the first visit.

Immunogenicity and safety were assessed in all participants. Adverse events (AE) defined in EMA NfG CPMP/BWP/214/96 were collected for 3 days after vaccination, solicited AE pre-listed in the diary card were collected for 7 days after vaccination, unsolicited AEs were collected for 21 days after vaccination, and serious adverse event (SAE) information was collected throughout the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants were enrolled in two age groups: participants aged 18 to 60 years and participants aged 61 years or older.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Fluzone Quadrivalent Influenza Vaccine
0.5-mL, Intramuscular, SH 2015 formulation
Other Name: Fluzone® Quadrivalent Influenza Vaccine
Study Arms  ICMJE
  • Experimental: Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years
    Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
    Intervention: Biological: Fluzone Quadrivalent Influenza Vaccine
  • Experimental: Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
    Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
    Intervention: Biological: Fluzone Quadrivalent Influenza Vaccine
Publications * Montalban C, Montellano MB, Santos J, Lavis N. Immunogenicity and safety of the 2015 Southern Hemisphere formulation of a split-virion inactivated quadrivalent vaccine. Hum Vaccin Immunother. 2018 Mar 4;14(3):593-595. doi: 10.1080/21645515.2017.1377378. Epub 2017 Oct 30.

*   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: June 1, 2018)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 17, 2015
Actual Primary Completion Date July 17, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants were >= 18 years of age on the day of inclusion .
  • Informed consent form had been signed and dated.
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • History of serious adverse reaction to any influenza vaccine.
  • Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.
  • Self-reported thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
  • Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.
  • Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) .
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
  • Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 3 weeks after vaccination).
  • Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
  • Personal history of Guillain-Barré syndrome.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion .
  • Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the participant. (No screening procedures were implemented.)
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
  • Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38°C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Identified as an Investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546192
Other Study ID Numbers  ICMJE GRC85
U1111-1143-9256 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date July 2018

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