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InfluenzaPhase 2NCT04363359

Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

A Phase 2 study testing 0.5ml Quadrivalent influenza vaccine, 0.25ml Quadrivalent influenza vaccine and 0.25ml Trivalent influenza vaccine(B/V) in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials. Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
0.5ml Quadrivalent influenza vaccine, 0.25ml Quadrivalent influenza vaccine and 0.25ml Trivalent influenza vaccine(B/V)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,980 participants
Where
1 siteChina
Study dates
15 Jan 2020to 14 Sep 2021
Phase
Phase 2
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 to 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants aged 6-35 months.
  • Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
  • The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.

Who cannot join

  • The underarm body temperature on the day of enrollment was > 37.0℃.
  • Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
  • Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
  • Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
  • A history of severe allergy to any vaccine or drug.
  • Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight < 2300g for girls, <2500g for boys).
Show all 19Show fewer
  • Dystocia, asphyxia rescue, nervous system damage history;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
  • A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
  • Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
  • Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
  • History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
  • Have received blood or blood-related products;
  • A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
  • A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
  • Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;
  • Participating in or planning to participate in other clinical trials in the near future;
  • The investigators determined that any conditions were inappropriate to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Provincial Center for Disease Control and Prevention

    Shangqiu, Henan, 450016

Other trials in China

About this study

Official title: Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials

To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.

Conditions
Influenza
Being tested
0.5ml Quadrivalent influenza vaccine, 0.25ml Quadrivalent influenza vaccine, 0.25ml Trivalent influenza vaccine(B/V), 0.25ml Trivalent influenza vaccine(B/Y)
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.5ml Quadrivalent influenza vaccineBiological

    The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains

  • 0.25ml Quadrivalent influenza vaccineBiological

    The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains

  • 0.25ml Trivalent influenza vaccine(B/V)Biological

    The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains

  • 0.25ml Trivalent influenza vaccine(B/Y)Biological

    The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains

Study groups in NCT04363359
Study groupRoleWhat they receive
Quadrivalent influenza vaccine HDExperimentalParticipants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.
Receives: Biological: 0.5ml Quadrivalent influenza vaccine
Quadrivalent influenza vaccine LDExperimentalParticipants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.
Receives: Biological: 0.25ml Quadrivalent influenza vaccine
Trivalent influenza vaccine VictoriaActive comparatorParticipants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.
Receives: Biological: 0.25ml Trivalent influenza vaccine(B/V)
Trivalent influenza vaccine YamagataActive comparatorParticipants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.
Receives: Biological: 0.25ml Trivalent influenza vaccine(B/Y)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. seroconversion rate of HI antibodies

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.

    Measured: 56 days

  2. seroprotection rate of HI antibodies

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.

    Measured: 56 days

  3. GMT and GMI of HI antibodies

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.

    Measured: 56 days

Secondary outcomes (1)

  1. Reactogenicity Events

    1. The proportion of all adverse reactions/events in each group through 30 days after the second dose.
    2. The proportion of serious adverse events (SAE) within 6 months after inoculation in each group.

    Measured: 30 days and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start15 Jan 2020
  3. Primary completion14 Sep 2021
  4. Study completion14 Sep 2021

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,980 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363359
Sponsor's protocol ID
CXSL1900048-Ⅰ+Ⅱ
Status last verified
Dec 2023
First submitted
17 Apr 2020
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.5ml Quadrivalent influenza vaccine, 0.25ml Quadrivalent influenza vaccine and 0.25ml Trivalent influenza vaccine(B/V) 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 19 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 26 Dec 2023. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

seroconversion rate of HI antibodies (time frame: 56 days). 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?

On the ClinicalTrials.gov record for NCT04363359.

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 26 Dec 2023.

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