Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years
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ClinicalTrials.gov Identifier: NCT03344029 |
Recruitment Status :
Completed
First Posted : November 17, 2017
Last Update Posted : June 25, 2019
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Condition or disease | Intervention/treatment | Phase |
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Influenza Flu | Biological: SP Shz TIV Biological: Hualan TIV | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1600 participants |
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 |
Official Title: | 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 |
Actual Study Start Date : | November 3, 2017 |
Actual Primary Completion Date : | May 22, 2018 |
Actual Study Completion Date : | May 22, 2018 |

Arm | Intervention/treatment |
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Experimental: SP Shz TIV
Participants aged 18 to 59 years will receive a single injection of SP Shz TIV.
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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 |
Active Comparator: Hualan TIV
Participants aged 18 to 59 years will receive a single injection of Hualan TIV.
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Biological: Hualan TIV
0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
Other Name: Hualan Trivalent Influenza Vaccine |
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344029
China | |
Sanofi Pasteur Investigational Site 001 | |
Huai'an, China, 223300 |
Study Director: | Medical Director | Sanofi Pasteur, a Sanofi Company |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT03344029 |
Other Study ID Numbers: |
FST00002 U1111-1183-5912 ( Other Identifier: WHO Universal Trial Number (UTN) ) |
First Posted: | November 17, 2017 Key Record Dates |
Last Update Posted: | June 25, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
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. |
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 |
Influenza Flu |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |