GCPNCT06334510
Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations.
An observational study of GCP, run by Hualan Biological Bacterin Co. Ltd. at 1 site in China.
Trial summary
To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare… Read more about this study
- Who is it for?
- Ages 3 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- GCP
- What is being tested?
- One dose of quadrivalent influenza virus split vaccine was administered
- Type of treatment
- Vaccines
- How many people
- 4,900 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2021to 28 Mar 2023
- Phase
- Observational
- 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 3 to 74 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy people aged 3 years and older
Who may be able to join
- Healthy people aged 3 years and above;
- I (or/and his/her legal guardian/authorized representative) can comply with the requirements of the clinical trial protocol after informed consent and voluntary signed informed consent;
- No contraindications of quadrivalent influenza vaccine in the package insert and meet the vaccination requirements after medical history inquiry.
Who cannot join
- Allergy to any component of the quadrivalent influenza vaccine, including egg, excipients, formaldehyde, or Triton X-100;
- people with a history of anaphylaxis after vaccination (allergy to any previous vaccination);
- Acute disease, severe chronic disease, acute onset of chronic disease, cold and fever;
- Axillary body temperature ≥37.3℃ (> 14 years old) and ≥37.5℃ (≤14 years old) before vaccination;
- Uncontrolled epilepsy;
- patients with progressive neurological disease or a history of Guillain-Barre syndrome;
- receiving immunoglobulin injection for less than one month;
- vaccination with live attenuated vaccine within 14 days before and other vaccines within 7 days before vaccination;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Clinical Study on Safety and Efficacy of Quadrivalent Influenza Virus Split Vaccine in Larger Population
To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰.
Read the detailed description
The study was divided into two parts. The first part was an inter-batch consistency study (a randomized, double-blind, 1050 subjects aged 18-59 years). The second part was the safety and immunogenicity study in the expanded population aged 3 years and above (enrollment 4900).were selected to receive of normal commercially available quadrivalent influenza vaccine。 Safety observation: follow-up was conducted to observe the occurrence of AE within 30 minutes (0 day) and 0-30 days after vaccination, and the occurrence of SAE within 6 months after vaccination.
Immunogenicity observation: Blood samples were collected from all subjects before and 30 days after vaccination for influenza virus HI antibody detection。 According to the European Union seasonal influenza evaluation criteria, if the HI antibody seroconversion rate of each subtype of influenza virus was ≥40%, the HI antibody positive rate was ≥70%, and the GMI of each subtype of influenza virus was ≥2.5 times 30 days after any dose of vaccination, the vaccination schedule was considered to have acceptable immunogenicity.
Safety outcome MEASURES The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated.
Note: Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows:
Inoculation site (local) adverse events: pain, induration, swelling, rash, redness, pruritus, cellulitis.
Adverse events at non-inoculated sites (systemic) included fever, diarrhea, constipation, dysphagia, anorexia, vomiting, nausea, myalgia (non-inoculated sites), arthralgia, headache, cough, dyspnea, pruritus at non-inoculated sites (without skin lesions), mucocutaneous abnormalities, irritation/inhibition, acute anaphylaxis, and fatigue/fatigue.
- Conditions
- GCP
- Being tested
- One dose of quadrivalent influenza virus split vaccine was administered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One dose of quadrivalent influenza virus split vaccine was administeredBiological
Safety observation: All 4900 vaccine recipients participated in the safety observation after vaccination, and were followed up for adverse events (AE) within 30 minutes and 0-30 days after vaccination, and SAEs within 6 months after vaccination.
In addition to 1050 recipients aged 18-59 years who were included in the first layer test, 350 recipients aged 3-17 years and 350 recipients aged ≥60 years were randomly selected from each group. Blood samples were collected before and 30 days after vaccination for influenza virus HI antibody detection.
| Study group | Role | What they receive |
|---|---|---|
| Approval consistency study | A total of 1050 recipients aged 18-59 years were enrolled in this study. Blood samples were collected before and 30 days after vaccination. Hemagglutination inhibition (HI) antibody to influenza virus was detected in the serum of all recipients to evaluate the inter-batch consistency of the vaccine. Receives: Biological: One dose of quadrivalent influenza virus split vaccine was administered | |
| Safety and immunogenicity in a larger vaccination cohort aged 3 years and older | 3850 recipients were enrolled in an open trial: safety observation after vaccination, follow-up for adverse events (AE) 30 minutes and 0-30 days after vaccination, and SAEs for 6 months after vaccination. Receives: Biological: One dose of quadrivalent influenza virus split vaccine was administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰.
The incidence of adverse events/reactions after quadrivalent influenza vaccination was observed, and the incidence of ① total adverse events/reactions, ② incidence of grade 3 or above adverse events/reactions and SAE, ③ incidence of adverse events/reactions according to severity classification of adverse events/reactions and ④ incidence of symptomatic adverse events/reactions were calculated.
Measured: The safety was observed until 6 months after the full course of immunization
Secondary outcomes (1)
To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years.
The lower limit of the 95% confidence interval (CI) of the seroconversion rate (SCR) of hemagglutination inhibition (HAI) antibodies against each virus strain after vaccination was ≥40%. The lowest dilution used in the assay was 1 in 10. Seroconversion was defined as a prevaccination HAI titer of <1:10 and a postvaccination titer of ≥1:40 or a prevaccination titer of ≥1:10 and a 4-fold or greater increase in titer after vaccination.
Measured: Before and 30 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start17 Nov 2021
- Primary completion20 Jan 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GCPStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334510
- Sponsor's protocol ID
- HL-SJLG-2021-Ⅳ-01
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Study on Safety and Efficacy of Quadrivalent Influenza Virus Split Vaccine in Larger Population
- ClinicalTrials.gov ID
- NCT06334510
- Acronym / sponsor ID
- HL-SJLG-2021-Ⅳ-01
- Conditions
- GCP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,900 participants (actual)
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 28 Mar 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 inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰.
Detailed description
The study was divided into two parts. The first part was an inter-batch consistency study (a randomized, double-blind, 1050 subjects aged 18-59 years). The second part was the safety and immunogenicity study in the expanded population aged 3 years and above (enrollment 4900).were selected to receive of normal commercially available quadrivalent influenza vaccine。 Safety observation: follow-up was conducted to observe the occurrence of AE within 30 minutes (0 day) and 0-30 days after vaccination, and the occurrence of SAE within 6 months after vaccination.
Immunogenicity observation: Blood samples were collected from all subjects before and 30 days after vaccination for influenza virus HI antibody detection。 According to the European Union seasonal influenza evaluation criteria, if the HI antibody seroconversion rate of each subtype of influenza virus was ≥40%, the HI antibody positive rate was ≥70%, and the GMI of each subtype of influenza virus was ≥2.5 times 30 days after any dose of vaccination, the vaccination schedule was considered to have acceptable immunogenicity.
Safety outcome MEASURES The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated.
Note: Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows:
Inoculation site (local) adverse events: pain, induration, swelling, rash, redness, pruritus, cellulitis.
Adverse events at non-inoculated sites (systemic) included fever, diarrhea, constipation, dysphagia, anorexia, vomiting, nausea, myalgia (non-inoculated sites), arthralgia, headache, cough, dyspnea, pruritus at non-inoculated sites (without skin lesions), mucocutaneous abnormalities, irritation/inhibition, acute anaphylaxis, and fatigue/fatigue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Approval consistency study | – | Biological: One dose of quadrivalent influenza virus split vaccine was administeredA total of 1050 recipients aged 18-59 years were enrolled in this study. Blood samples were collected before and 30 days after vaccination. Hemagglutination inhibition (HI) antibody to influenza virus was detected in the serum of all recipients to evaluate the inter-batch consistency of the vaccine. |
| Safety and immunogenicity in a larger vaccination cohort aged 3 years and older | – | Biological: One dose of quadrivalent influenza virus split vaccine was administered3850 recipients were enrolled in an open trial: safety observation after vaccination, follow-up for adverse events (AE) 30 minutes and 0-30 days after vaccination, and SAEs for 6 months after vaccination. |
Who may qualify
- Ages
- 3 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy people aged 3 years and older
Key inclusion criteria (3 listed)
- Healthy people aged 3 years and above;
- I (or/and his/her legal guardian/authorized representative) can comply with the requirements of the clinical trial protocol after informed consent and voluntary signed informed consent;
- No contraindications of quadrivalent influenza vaccine in the package insert and meet the vaccination requirements after medical history inquiry.
Key exclusion criteria (8 listed)
- Allergy to any component of the quadrivalent influenza vaccine, including egg, excipients, formaldehyde, or Triton X-100;
- people with a history of anaphylaxis after vaccination (allergy to any previous vaccination);
- Acute disease, severe chronic disease, acute onset of chronic disease, cold and fever;
- Axillary body temperature ≥37.3℃ (> 14 years old) and ≥37.5℃ (≤14 years old) before vaccination;
- Uncontrolled epilepsy;
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 |
|---|---|---|
| One dose of quadrivalent influenza virus split vaccine was administeredSafety observation: All 4900 vaccine recipients participated in the safety observation after vaccination, and were followed up for adverse events (AE) within 30 minutes and 0-30 days after vaccination, and SAEs within 6 months after vaccination. In addition to 1050 recipients aged 18-59 years who were included in the first layer test, 350 recipients aged 3-17 years and 350 recipients aged ≥60 years were randomly selected from each group. Blood samples were collected before and 30 days after vaccination for influenza virus HI antibody detection. | Biological | Approval consistency study, Safety and immunogenicity in a larger vaccination cohort aged 3 years and older |
Primary outcome
To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰.
Time frame: The safety was observed until 6 months after the full course of immunization
The incidence of adverse events/reactions after quadrivalent influenza vaccination was observed, and the incidence of ① total adverse events/reactions, ② incidence of grade 3 or above adverse events/reactions and SAE, ③ incidence of adverse events/reactions according to severity classification of adverse events/reactions and ④ incidence of symptomatic adverse events/reactions were calculated.
1 secondary outcome
To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years.
Time frame: Before and 30 days after immunization
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 28 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GCP, run by Hualan Biological Bacterin Co. Ltd. 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 8 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 28 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰. (time frame: The safety was observed until 6 months after the full course of immunization). 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 28 Mar 2024.