ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years

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: NCT03344029
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

November 9, 2017
November 17, 2017
May 30, 2018
November 3, 2017
May 22, 2018   (Final data collection date for primary outcome measure)
  • Summary of Geometric Mean Titers (GMTs) of Each of the Three Strains of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
    GMTs were assessed using the hemagglutination inhibition (HAI) assay.
  • Percentage of Participants with TIV Seroconversion Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
    Seroconversion rates were assessed using a HAI assay. Seroconversion was defined as titers <10 (1/dil) at Day 0 and post-injection titer ≥40 (1/dil) at Day 28, or titer ≥10 (1/dil) at Day 0 and a ≥4-fold increase in titer (1/dil) at Day 28.
Same as current
Complete list of historical versions of study NCT03344029 on ClinicalTrials.gov Archive Site
  • GMTs of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
    GMTs were assessed using the HAI assay.
  • GMT Ratios of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
    GMTs were assessed using the HAI assay.
  • Percentage of Participants with TIV Antibody Titers ≥10 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
    TIV antibody levels were assessed using the HAI assay.
  • Percentage of Participants with TIV Antibody Titers ≥40 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
    TIV antibody levels were assessed using the HAI assay.
  • Percentage of Participants Reporting Solicited Injection site or Systemic Reactions Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years
Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Healthy Chinese Subjects Aged 18 to 59 Years
This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.
This study is designed to demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates for the 3 strains (A/H1N1, A-H3N2, and B) after a single dose of either the SP Shz TIV or Hualan TIV. Vaccine immune responses will be assessed on Day 0 (pre-vaccination) and Day 28 post-vaccination. Solicited reactions will be collected from Day 0 up to Day 7 after vaccination, unsolicited non-serious adverse events (AEs) will be collected from Day 0 up to Day 28 post-vaccination, and serious AEs will be collected from Day 0 up to 6 months post-vaccination.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Blind-observer, monocenter, randomized, comparative, Phase IV study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
An observer-blind procedure will be followed in the study such that neither the Investigator, subject, nor the Sponsor will know which vaccine has been administered.
Primary Purpose: Prevention
  • Influenza
  • Flu
  • Biological: SP Shz TIV
    0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
    Other Name: Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine
  • Biological: Hualan TIV
    0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
    Other Name: Hualan Trivalent Influenza Vaccine
  • Experimental: SP Shz TIV
    Participants aged 18 to 59 years will receive a single injection of SP Shz TIV.
    Intervention: Biological: SP Shz TIV
  • Active Comparator: Hualan TIV
    Participants aged 18 to 59 years will receive a single injection of Hualan TIV.
    Intervention: Biological: Hualan TIV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1600
Same as current
May 22, 2018
May 22, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged ≥ 18 to 59 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non- childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile
  • Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine or planned receipt of any vaccine within the period from 2 weeks before trial vaccination to 2 weeks following trial vaccination
  • Previous vaccination against influenza (in the previous 6 months) with either the trial vaccines or another vaccine
  • Receipt of immune globulins, blood or blood-derived product in the past 3 months
  • 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)
  • Known systemic hypersensitivity to any of the vaccines components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Identified as an Investigator or employee of the 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 the Investigator or employee with direct involvement in the proposed study
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT03344029
FST00002
U1111-1183-5912 ( Other Identifier: WHO Universal Trial Number (UTN) )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available, Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com.
URL: http://
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
Sanofi
May 2018

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