Preliminary Study on Safety and Immunogenicity of Influenza A (H7N9) Vaccine in the Population

June 20, 2017 updated by: Hualan Biological Bacterin Co. Ltd.

Adopt the design of random, blind method and placebo to parallel control and progressive methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9) vaccine (two types, one type with two specifications) on people of different ages. The vaccines used for testing include: influenza A (H7N9) virus inactivated vaccine/split influenza vaccine (15μg /dose), influenza A (H7N9) virus inactivated vaccine/split influenza vaccine (30μg / dose), influenza A (H7N9) virus inactivated vaccine/whole influenza vaccine (7.5μg / dose) and influenza A (H7N9) virus inactivated vaccine/ whole influenza vaccine (15μg / dose).

The study between different subgroups was carried out in an orderly and progressive manner, that is, each kind of vaccine by the dose is from low to high according to the order of age from old to young. Firstly, the study on 15μg/dose split vaccine group (aged 18 and above) and 7.5μg/dose whole-virus vaccine group (aged 18 and above) was carried out and then the study on 15μg/dose split vaccine group (aged 12-17) and 7.5μg/dose whole-virus vaccine group (aged 12-17) was conducted upon 7-day safety was confirmed after the vaccination, finally the study on 30μg/dose split vaccine group (aged 18 and above) and 15μg/dose whole-virus vaccine group (aged 18 and above) was done. By that analogy for the same conditions, the next group of test can be done after the 7-day safety of the last group of vaccine is confirmed.

Subjects and researchers didn't know the formulations of the vaccines used. The vaccine is injected into the upper arm deltoid muscle. After 30 minutes of field observation on safety, the subjects' axillary temperature shall be recorded on the Record Book prepared by the research and local and systemic reactions to injection at the 6th, 24th, 48th, and 72th hour and on the 4th, 8th, 21st and 30th day shall also be recorded. This paper collected 5 serum samples: day 0 (before the first-dose vaccination), day 4 (after the first-dose vaccination), day 21 (before the second-dose vaccination), day 25 (fourth day after the second-dose vaccination) and day 42 (21st day after the second-dose vaccination), of which, blood samples on day 0, 21 and 42 should be stored at 18℃ for antibody detection and the remaining 2 blood samples are only used for blood routine examination, routine urine test, blood biochemistry and other laboratory examinations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
588

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Permanent healthy residents with normal intelligence meet the minimum age requirement. Literate and willing to provide written informed consent.
  • A signed informed consent.
  • Willing to comply with the rules of the clinical trial scheme. Accept the blood examination before and after immunization and cooperate follow-up visit.

Exclusion Criteria:

  • Exclusion criteria of the first vaccination A person with a history of H7N9 virus infection or suspected infection; Who is allergic to any component of trial vaccine (and past history of any allergy vaccination), especially allergic to eggs; No spleen, or the spleen isn't working; Autoimmune diseases or immunodeficiency, have been treated with immunosuppressant over the past six months; Acute attack of acute illness or chronic disease in almost 7 days; Accept blood products in three months before getting inoculated testing vaccine; Got inoculated active virus vaccine in 14 days or subtype or inactivated virus in 7 days before getting inoculated testing vaccine; Who had been infected by any acute diseases ;
  • Who had fever in past 3 days (axillary temperature ≥ 38 ℃);
  • Who is participating another clinical trial
  • Who had allergies, convulsions, epilepsy, encephalopathy, psychosis history or family history;
  • Who is suffering from thrombocytopenia or other coagulation disorder, which may result to intramuscular injection contraindication; The laboratory detection indexes are abnormal before getting inoculated testing vaccine; The females are in suckling period, pregnancy, plan of pregnant or pregnancy tests (positive).
  • Who had fever in the past 3 days (axillary temperature ≥ 37.1 ℃). Any other situations investigator think about may affect trial evaluation. Exclusion criteria of the second vaccination Level 3 and above allergic reactions (local and general side effect, vital signs and abnormal laboratory index) related to vaccine were appeared after the first vaccination.

Level 2 and above allergic reactions related to vaccine were appeared after the first vaccination.

-Any other situations investigator think about may affect trial evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: H7N9 split influenza vaccine (15μg/dose)

This group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines)，12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines)，≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines).

Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
Biological: Influenza A (H7N9) virus vaccine
To prevent the infection of H7N9 virus.
Placebo Comparator: H7N9 split influenza vaccine (30μg/dose)

This group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines)，12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines)，≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines).

Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
Biological: Influenza A (H7N9) virus vaccine
To prevent the infection of H7N9 virus.
Placebo Comparator: H7N9 whole virus influenza vaccine (7.5μg/dose)

This group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines)，≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines).

Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
Biological: Influenza A (H7N9) virus vaccine
To prevent the infection of H7N9 virus.
Placebo Comparator: H7N9 whole virus influenza vaccine (15μg/dose)

This group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines)，≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines).

Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
Biological: Influenza A (H7N9) virus vaccine
To prevent the infection of H7N9 virus.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time Frame: 20 days after the inoculation of first needle
Inspect the measures like pain, induration, redness, red and swollen, rash, pruritus, skin mucosa reaction, etc. All these data is collected through questionnaires.
20 days after the inoculation of first needle
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time Frame: 30 days after the inoculation of second needle
Inspect the measures like pain, induration, redness, red and swollen, rash, pruritus, skin mucosa reaction, etc. All these data is collected through questionnaires.
30 days after the inoculation of second needle
587 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time Frame: 20 days after the inoculation of first needle
Inspect the measures like fever, headache, fatigue, weak, nausea, diarrhea, cough, allergic reaction, etc. All these data is collected through questionnaires.
20 days after the inoculation of first needle
587 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time Frame: 30 days after the inoculation of second needle
Inspect the measures like fever, headache, fatigue, weak, nausea, diarrhea, cough, allergic reaction, etc. All these data is collected through questionnaires.
30 days after the inoculation of second needle

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.
Time Frame: 21 days after the inoculation of first needle
China pharmaceutical biological products analysis institute tests the HI antibody titer of H7N9 influenza virus in blood samples by adopting internationally-used micro-hemagglutination-inhibition test.
21 days after the inoculation of first needle
558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.
Time Frame: 42 days after the inoculation of second needle
China pharmaceutical biological products analysis institute tests the HI antibody titer of H7N9 influenza virus in blood samples by adopting internationally-used micro-hemagglutination-inhibition test.
42 days after the inoculation of second needle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hualan Biological Bacterin Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015L00054

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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