A Phase 2 interventional study of Influenza virus split vaccine (0.7mL/vial) and Influenza virus split vaccine in Influenza, sponsored by Shanghai Institute Of Biological Products. Not yet recruiting at 2 sites in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Shanghai Institute Of Biological Products (part of Sinopharm) · Phase 2, Interventional, and Prevention
Among 10 studies in Influenza, Human by Shanghai Institute Of Biological Products — 2 open to participants now, 2 under way, none of them phase 3. Influenza, Human · Shanghai Institute Of Biological Products.
Among the 10 studies in Influenza, Human by Shanghai Institute Of Biological Products, this one is the 3rd largest by planned enrollment, is the only one that started in 2026, is one of 5 in phase 2, and was the 10th registered.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →2 of the 10 studies in Influenza, Human by Shanghai Institute Of Biological Products are open now, in 1 country. Each count lists the studies.
Of the 119 Influenza, Human studies recruiting now, 62 (52%) set no upper age limit and 47 (39%) stop at 75 or younger; 31 take children under 18; 65 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2026.
Median enrollment 430 across the 10 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Shanghai Institute Of Biological Products is the lead sponsor of 34 studies on the registry; 14 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Influenza, Human by Shanghai Institute Of Biological Products, from their registry updates:
Nothing recorded among them since 2026-09-25.
To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.
This is a randomized, blinded, parallel controlled trial design, a total of 1200 participants aged ≥ 60 years were enrolled in the study. Study participants were randomly vaccinated with either the experimental vaccine: influenza virus split vaccine (0.7mL/dose) or the control vaccine: influenza virus split vaccine, at a 1:1 ratio. One dose of the vaccine was administered on day 0 for immunogenicity and safety evaluation.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Influenza virus split vaccine (0.7mL/vial)
Biological: Influenza virus split vaccine (0.7mL/vial)
Influenza virus split vaccine
Biological: Influenza virus split vaccine
Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine.
Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each.
Seroconversion rate
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Ratio of ≥1:40
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Geometric mean titer (GMT)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Geometric mean increase (GMI)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.
Time frame: 7 days after vaccination
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
Time frame: 30 days after vaccination
Serious Adverse Events (SAEs)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame: 6 months after vaccination
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Institute Of Biological Products →