A Phase 1 interventional study of Shz QIV 0.25 mL, 2 doses and Shz QIV 0.5 mL, 2 doses in Influenza and Flu, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in China. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 1, 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 107th largest by enrollment of the 126 interventional ones that give a count, is one of 7 that started in 2019, is one of 11 in phase 1, and was the 91st 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: 6 Months and older · 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. 7 started in 2019.
This study's enrollment of 101 is below 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.
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This study is registered under Sanofi Pasteur, a Sanofi Company, one of the names counted as Sanofi. Under that name alone:
Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) 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 phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6 months and older in China.
Participants aged 9 years or more will receive a single dose of Shz QIV, and participants aged 6 months to 8 years will receive two doses of Shz QIV administered 28 days apart.
Healthy participants will either receive a single dose (participants 9 years or older) or two doses (participants 6 months to 8 years) of the Shz QIV. Safety in terms of serious adverse events, solicited injection site and systemic reactions, and unsolicited adverse events will be collected before and 28 days after each and any dose.
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.
Shz QIV 0.25 mL, 2 doses
Biological: Shz QIV 0.25 mL, 2 doses
Shz QIV 0.5 mL, 2 doses
Biological: Shz QIV 0.5 mL, 2 doses
Shz QIV 0.5 mL, single dose
Biological: Shz QIV 0.5 mL, single dose
Shz QIV 0.5 mL, single dose
Biological: Shz QIV 0.5 mL, single dose
Shz QIV 0.5 mL, single dose
Biological: Shz QIV 0.5 mL, single dose
Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart.
Administered intramuscularly into the deltoid muscle, 28 days apart
Administered intramuscularly into the deltoid muscle.
Occurrence of serious adverse reactions or Grade 3 non-serious adverse reactions following vaccination with Shz QIV
Number of participants reporting serious adverse reactions and Grade 3 adverse reactions following a vaccination with Shz QIV
Time frame: Within 28 days after vaccination
Occurrence of unsolicited systemic AEs reported in the 30 minutes following vaccination/each and any vaccination
Time frame: Within 30 minutes after vaccination
Occurrence of solicited (prelisted in the subject diary and the electronic Case Report Form [CRF]) injection site reactions and systemic reactions occurring between D0 and D7 after vaccination/each and any vaccination
Time frame: Up to 7 days after vaccination
Occurrence of unsolicited (spontaneously reported) AEs from D0 to D28 after vaccination/each and any vaccination
Time frame: Up to 7 days after vaccination
Occurrence of SAEs
Time frame: Up to 56 days after the 1st 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 Feb 2019 to primary completion in Jun 2019, 3 months.
Of 94 industry-sponsored phase 1 interventional studies under Influenza, Human, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 3 months is below that.
Counting every sponsor, half of 148 studies reached it within 11 months; a quarter within 4 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company →