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

NCT03196661 | Completed Phase 1

• 1 other identifier: 2015L00054
• Study Type: interventional
• Target: 588
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Influenza A

Keywords

safety investigation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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 Outcomes (2)

• 558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.

  21 days after the inoculation of first needle

• 558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.

  42 days after the inoculation of second needle

Study Arms (4)

H7N9 split influenza vaccine (15μg/dose)

PLACEBO COMPARATOR

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

H7N9 split influenza vaccine (30μg/dose)

PLACEBO COMPARATOR

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

H7N9 whole virus influenza vaccine (7.5μg/dose)

PLACEBO COMPARATOR

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

H7N9 whole virus influenza vaccine (15μg/dose)

PLACEBO COMPARATOR

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

Interventions

Influenza A (H7N9) virus vaccine BIOLOGICAL

To prevent the infection of H7N9 virus.

H7N9 split influenza vaccine (15μg/dose); H7N9 split influenza vaccine (30μg/dose); H7N9 whole virus influenza vaccine (15μg/dose); H7N9 whole virus influenza vaccine (7.5μg/dose)

Eligibility Criteria

• Age: 3 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hualan Biological Bacterin Co. Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial achieved the goal of random and blind method through blinded method for vaccine. All the testing vaccines and reference vaccines are provided by sponsor, and entrust Medical statistics unit to blind.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects were inoculated with influenza A (H7N9) virus inactivated vaccine/split influenza vaccine or placebo.

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: June 23, 2017
• Study Start: November 6, 2015
• Primary Completion: July 5, 2016
• Study Completion: March 23, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-05