A Phase 4 interventional study of SP Shz TIV and Hualan TIV in Influenza and Flu, sponsored by Sanofi. Completed at 1 site in China. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 4, Interventional, and Prevention
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Among 139 studies in Influenza, Human by Sanofi — 4 open to participants now, 6 under way, 1 of them phase 3. Influenza, Human · Sanofi.
Among the 139 studies in Influenza, Human by Sanofi, this one is the 20th largest by enrollment of the 126 interventional ones that give a count, is one of 5 that started in 2017, is one of 33 in phase 4, and was the 89th registered.
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →4 of the 139 studies in Influenza, Human by Sanofi are open now, in 3 countries. Recruiting first, the newest first:
Sanofi · Sites in Poland
Ages 60+ · Healthy volunteers
Sanofi · Sites in Korea, Republic of
Ages 65+ · Healthy volunteers
Sanofi · Sites in United States
Ages 18+ · Healthy volunteers
Sanofi · Sites in Korea, Republic of
Ages 65+ · Healthy volunteers
By country, each count listing its studies:
Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.
This study: 18 Years to 59 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
139 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 47 · Phase 3 35 · Phase 4 33
First in 2003; this study’s year is marked. 5 started in 2017.
This study's enrollment of 1,600 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 305 across the 126 interventional studies, 1,001 across the 13 observational. Of the 133 that completed or were terminated, 73 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
2 of the studies in Influenza, Human by Sanofi that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06907511SanofiStudy to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older | 2026-12-01 |
| NCT07516418SanofiStudy of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age | 2027-04-04 |
Add all 2 to your calendar (.ics) → With an account.
Among the 139 studies in Influenza, Human by Sanofi, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 18 to 59 years will receive a single injection of SP Shz TIV.
Biological: SP Shz TIV
Participants aged 18 to 59 years will receive a single injection of Hualan TIV.
Biological: Hualan TIV
0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
Also known as: Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine
0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
Also known as: 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
GMTs were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 28 post-vaccination
Percentage of Participants with TIV Seroconversion Following a Single Dose of SP Shz TIV or Hualan TIV
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.
Time frame: Day 28 post-vaccination
GMTs of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV
GMTs were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
GMT Ratios of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV
GMTs were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
Percentage of Participants with TIV Antibody Titers ≥10 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV
TIV antibody levels were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
Percentage of Participants with TIV Antibody Titers ≥40 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV
TIV antibody levels were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection site or Systemic Reactions Following a Single Dose of SP Shz TIV or Hualan TIV
Solicited injection site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Time frame: Day 0 up to Day 7 post-vaccination
Plan to share: Yes — 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://vivli.org
Ran from Nov 2017 to primary completion in May 2018, 6 months.
Of 37 industry-sponsored phase 4 interventional studies under Influenza, Human, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's 6 months is above that.
Counting every sponsor, half of 138 studies reached it within 14 months; a quarter within 3 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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