InfluenzaPhase 1NCT06342349
A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.
A Phase 1 study testing Quadrivalent influenza virus split vaccine (MDCK cells), Quadrivalent influenza virus split vaccine (Chicken embryo) and Phosphate buffer solution in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent influenza virus split vaccine (MDCK cells), Quadrivalent influenza virus split vaccine (Chicken embryo) and Phosphate buffer solution
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy individuals aged 6 months or more on the day of enrollment who can provide legal identification documents.
- Volunteers and/or their legal guardians (or entrusted persons) have informed consent, voluntarily participate, and sign an informed consent form.
- Volunteers and/or their legal guardians (or entrusted persons) have the ability (non-illiterate) to understand the research procedures, could use thermometers, scales, and fill out diary cards as required, and can comply with the requirements of the clinical trial protocol to complete the clinical study.
Who cannot join
- （Exclusion criteria for the first dose）
- On the day of enrollment, the underarm temperature of individuals ≤ 14 years old is ≥ 37.5 ℃, and on the day of enrollment, the underarm temperature of individuals>14 years old is ≥ 37.3 ℃.
- Women of childbearing age (from menarche to menopause for ≤ 1 year) who have tested positive for urinary pregnancy test, and those who are breastfeeding, pregnant, or planning to conceive within 6 months.
- Have had or are currently suffering from influenza within the past 3 months (confirmed by clinical, serological, or microbiological methods).
- Individuals aged 6 months to 8 years have previously received any influenza vaccine (including registered or experimental) or have planned to receive any influenza vaccine during the study period. Individuals aged 9 and above have received any influenza vaccine (including registered or experimental) within the past 6 months or have planned to receive any influenza vaccine within the past 6 months.
- Has a history of allergic reactions to any component of the research vaccine, including consuming eggs or using gentamicin sulfate.
Show all 31Show fewer
- Has any history of severe allergies to vaccines or drugs in the past. Population aged 6 to 35 months: premature birth (delivered before the 37th week of pregnancy), low birth weight (birth weight<2500g) infants.
- Population aged 6 to 35 months: those with a history of difficult childbirth, suffocation rescue, and neurological damage.
- Congenital malformations (clinically significant according to researchers) or developmental disorders, genetic defects, and severe malnutrition.
- Population aged 3-8 years and 6-35 months: individuals with abnormal growth and development, severe eczema.
- Suffering from acute illness or being in the acute phase of chronic illness within 3 days before vaccination.
- Used antipyretic and analgesic drugs or anti allergic drugs within 3 days before vaccination.
- Suffering from serious chronic diseases, serious cardiovascular diseases, hypertension beyond drug control (systolic pressure ≥ 140mmHg or diastolic pressure ≥ 90mmHg, only applicable to people aged 18 and above), diabetes with complications, liver and kidney diseases, malignant tumors, etc.
- Have a history of receiving attenuated live vaccines within 14 days (including the 14th day) before vaccination and have a history of receiving other vaccines within 7 days (including the 7th day).
- Individuals who receive immunotherapy or immunosuppressive therapy within 3 months (continuous oral or intravenous for more than 14 days).
- Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, or other autoimmune diseases.
- Asthma history, unstable in the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids.
- Have received blood or blood related products within the past 6 months.
- Individuals with progressive neurological disorders have a history of seizures, epilepsy, encephalopathy, Guillain Barre syndrome, psychiatric disorders, transverse myelitis, or family history.
- Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulation related diseases), or use anticoagulants within 3 weeks before vaccination.
- Non splenic, functional non splenic, splenectomy, or partial resection of other important organs.
- Plan to relocate before the end of the study or leave the local area for a long time during the scheduled study visit period.
- Being or planning to participate in other clinical trials in the near future.
- Abnormal laboratory testing indicators, except for minor abnormalities judged by doctors to have no clinical significance.
- The researcher determines any situation that is not suitable for participation in this clinical trial.
- （Exclusion criteria for the second dose）
- On the day of vaccination, the axillary body temperature is ≥ 37.5 ℃.
- Fever (axillary temperature ≥ 38.5 ℃) within 3 days before vaccination, or use of antipyretic and analgesic drugs or anti allergic drugs within 3 days before vaccination.
- Suffering from various acute or chronic diseases with acute attacks within 3 days before vaccination.
- Insufficient interval between vaccination of other vaccines (with a history of receiving attenuated live vaccines within 14 days (including the 14th day) before vaccination, and a history of receiving other vaccines within 7 days (including the 7th day).
- Other situations where researchers believe vaccination should be postponed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.
To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.
Read the detailed description
This is a single center, randomized, double-blind, controlled phase I clinical trial. Plan to include 300 participants aged 6 months and above. The experiment was divided into 5 age groups, with 60 cases each aged 6-35 months, 3-8 years, 9-17 years, 18-59 years, and ≥ 60 years old. Each age group was randomly assigned to the experimental group, control group, or placebo group in a 1:1:1 ratio. Among them, the participants aged 6 to 35 months and 3 to 8 years old will receive 2 doses throughout the entire process, with an interval of 28 days between each dose. Participants aged 9-17, 18-59, and ≥ 60 years old are vaccinated with one dose throughout the entire process.
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza virus split vaccine (MDCK cells), Quadrivalent influenza virus split vaccine (Chicken embryo), Phosphate buffer solution
- Keywords
- Quadrivalent influenza virus split vaccine, MDCK cells, Safety, Immunogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent influenza virus split vaccine (MDCK cells)Biological
Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose).
Quadrivalent influenza virus split vaccine (Chicken embryo)Biological
Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose).
Phosphate buffer solutionOther
Phosphate buffer solution without vaccine antigen(0.5ml/dose).
| Study group | Role | What they receive |
|---|---|---|
| SIBP-V03-I | Experimental | Quadrivalent influenza virus split vaccine (MDCK cells) Receives: Biological: Quadrivalent influenza virus split vaccine (MDCK cells) |
| QTV (chicken embryo) | Active comparator | Quadrivalent influenza virus split vaccine (chicken embryo) Receives: Biological: Quadrivalent influenza virus split vaccine (Chicken embryo) |
| Placebo | Placebo comparator | Phosphate buffer solution Receives: Other: Phosphate buffer solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after each dose of vaccination.
Measured: 7 days after each dose of vaccination
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Measured: 28 or 30 days after each dose of vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: 6 months after the last dose
Secondary outcomes (3)
Seroconversion rate
30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.
Measured: 30 days after the last dose of vaccination
Ratio of ≥1:40
30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.
Measured: 30 days after the last dose of vaccination
Geometric mean increase (GMI)
30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.
Measured: 30 days after the last dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start30 Mar 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, randomized, double-blind, controlled phase I clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shaanxi Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Guohua Li, Principal investigator, 0351-7553168
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342349
- Sponsor's protocol ID
- SIBP-V03-I
- Status last verified
- Feb 2025
- First submitted
- 26 Mar 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.
- ClinicalTrials.gov ID
- NCT06342349
- Acronym / sponsor ID
- SIBP-V03-I
- Conditions
- Influenza
- Keywords
- Quadrivalent influenza virus split vaccine, MDCK cells, Safety, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Shaanxi Provincial Center for Disease Control and Prevention
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.
Detailed description
This is a single center, randomized, double-blind, controlled phase I clinical trial. Plan to include 300 participants aged 6 months and above. The experiment was divided into 5 age groups, with 60 cases each aged 6-35 months, 3-8 years, 9-17 years, 18-59 years, and ≥ 60 years old. Each age group was randomly assigned to the experimental group, control group, or placebo group in a 1:1:1 ratio. Among them, the participants aged 6 to 35 months and 3 to 8 years old will receive 2 doses throughout the entire process, with an interval of 28 days between each dose. Participants aged 9-17, 18-59, and ≥ 60 years old are vaccinated with one dose throughout the entire process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a single center, randomized, double-blind, controlled phase I clinical trial.
| Arm | Type | Receives |
|---|---|---|
| SIBP-V03-I | Experimental | Biological: Quadrivalent influenza virus split vaccine (MDCK cells)Quadrivalent influenza virus split vaccine (MDCK cells) |
| QTV (chicken embryo) | Active comparator | Biological: Quadrivalent influenza virus split vaccine (Chicken embryo)Quadrivalent influenza virus split vaccine (chicken embryo) |
| Placebo | Placebo comparator | Other: Phosphate buffer solutionPhosphate buffer solution |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals aged 6 months or more on the day of enrollment who can provide legal identification documents.
- Volunteers and/or their legal guardians (or entrusted persons) have informed consent, voluntarily participate, and sign an informed consent form.
- Volunteers and/or their legal guardians (or entrusted persons) have the ability (non-illiterate) to understand the research procedures, could use thermometers, scales, and fill out diary cards as required, and can comply with the requirements of the clinical trial protocol to complete the clinical study.
Key exclusion criteria (31 listed)
- （Exclusion criteria for the first dose）
- On the day of enrollment, the underarm temperature of individuals ≤ 14 years old is ≥ 37.5 ℃, and on the day of enrollment, the underarm temperature of individuals>14 years old is ≥ 37.3 ℃.
- Women of childbearing age (from menarche to menopause for ≤ 1 year) who have tested positive for urinary pregnancy test, and those who are breastfeeding, pregnant, or planning to conceive within 6 months.
- Have had or are currently suffering from influenza within the past 3 months (confirmed by clinical, serological, or microbiological methods).
- Individuals aged 6 months to 8 years have previously received any influenza vaccine (including registered or experimental) or have planned to receive any influenza vaccine during the study period. Individuals aged 9 and above have received any influenza vaccine (including registered or experimental) within the past 6 months or have planned to receive any influenza vaccine within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent influenza virus split vaccine (MDCK cells)Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose). | Biological | SIBP-V03-I |
| Quadrivalent influenza virus split vaccine (Chicken embryo)Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose). | Biological | QTV (chicken embryo) |
| Phosphate buffer solutionPhosphate buffer solution without vaccine antigen(0.5ml/dose). | Other | Placebo |
Primary outcome
Solicited Adverse Events (AEs)
Time frame: 7 days after each dose of vaccination
Adverse events defined by the protocol that occurred to the participant during 0-7 days after each dose of vaccination.
Unsolicited Adverse Events
Time frame: 28 or 30 days after each dose of vaccination
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Serious Adverse Events (SAE)
Time frame: 6 months after the last dose
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
3 secondary outcomes
Seroconversion rate
Time frame: 30 days after the last dose of vaccination
Ratio of ≥1:40
Time frame: 30 days after the last dose of vaccination
Geometric mean increase (GMI)
Time frame: 30 days after the last dose of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guohua Li principal investigator
0351-7553168
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quadrivalent influenza virus split vaccine (MDCK cells), Quadrivalent influenza virus split vaccine (Chicken embryo) and Phosphate buffer solution in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited Adverse Events (AEs) (time frame: 7 days after each dose of vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.