NCT01676675

Brief Summary

Influenza is an acute respiratory infection caused by influenza virus with high incidence and serious complications even causing death. According to the announcement released by the World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse consequences for human health and social welfare worldwide. From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has attracted the WHO and national government great attention. So it is meaningful to develop vaccine to provide effective antibody to reduce the number of infections. The objective of this study is to evaluate the safety and preliminary immunogenicity of a whole virus inactivated influenza H5N1 vaccine.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

5 months

First QC Date

August 29, 2012

Last Update Submit

March 14, 2013

Conditions

Healthy

Keywords

whole virusinactivatedinfluenzaH5N1 vaccinesafetyimmunogenicity

Outcome Measures

Primary Outcomes (5)

  • the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    Frequency of systemic and local adverse reactions within 21 days after the first doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    21 days after the first dose

  • the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    Frequency of systemic and local adverse reactions within 21 days after the second doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    21 days after the second dose

  • the immunogenicity of the vaccine after first dose

    the seroconversion rate and GMFI of antibodies on day 21 after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    on day 21±3 days

  • the immunogenicity of the vaccine after second dose

    the seroconversion rate and GMFI of antibodies on day 21 after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    on day 42±7 days

  • the immunogenicity of the vaccine after whole immunization

    the seroconversion rate and GMFI of antibodies 3 months after the second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years

    3 months after second dose (±14 days)

Secondary Outcomes (2)

  • abnormal change of hematological examination and the function of liver and kidney after first dose

    3 days after first dose

  • abnormal change of hematological examination and the function of liver and kidney after second dose

    3 days after second dose

Study Arms (8)

7.5μg/0.5ml in subjects(12-17 years old)

EXPERIMENTAL

whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml in 30 adolescents aged 12-17 years old on day 0, 21

Biological: 7.5μg /0.5ml

15μg/0.5ml in subjects(12-17 years old)

EXPERIMENTAL

whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml in 30 adolescents aged 12-17 years old on day0,21

Biological: 15.0μg /0.5ml

30μg/0.5ml in subjects(12-17 years old)

EXPERIMENTAL

whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml in 30 adolescents aged 12-17 years old on day0,21

Biological: 30.0μg /0.5ml

7.5μg/0.5ml in subjects(18-60 years old)

EXPERIMENTAL

whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21

Biological: 7.5μg /0.5ml

15μg/0.5ml in subjects(18-60 years old)

EXPERIMENTAL

whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21

Biological: 15.0μg /0.5ml

30μg/0.5ml in subjects(18-60 years old)

EXPERIMENTAL

whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21

Biological: 30.0μg /0.5ml

0/0.5ml in adolescents (12-17 years old)

PLACEBO COMPARATOR

0/0.5ml placebo in 30 adolescents aged 12-17 years old on day 0, 21

Biological: 0/0.5ml placebo

0/0.5ml in adults(18-60 years old)

PLACEBO COMPARATOR

0/0.5ml placebo in 30 adults aged 18-60 years old on day 0, 21

Biological: 0/0.5ml placebo

Interventions

7.5μg /0.5mlBIOLOGICAL

whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval

7.5μg/0.5ml in subjects(12-17 years old)7.5μg/0.5ml in subjects(18-60 years old)
15.0μg /0.5mlBIOLOGICAL

whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval

15μg/0.5ml in subjects(12-17 years old)15μg/0.5ml in subjects(18-60 years old)
30.0μg /0.5mlBIOLOGICAL

whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval

30μg/0.5ml in subjects(12-17 years old)30μg/0.5ml in subjects(18-60 years old)
0/0.5ml placeboBIOLOGICAL

0/0.5ml placebo, two doses, 21 days interval

0/0.5ml in adolescents (12-17 years old)0/0.5ml in adults(18-60 years old)

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy subjects aged from 12 to 60 years old of normal intelligence;
  • The subjects' guardians are able to understand and sign the informed consent;
  • Subjects established as healthy after medical history questioning, physical examination and clinical decision;
  • Subjects who can comply with the requirements of the clinical trial protocol;
  • Subjects who have never received influenza H5N1 vaccine and other preventive products;
  • Subjects with temperature ≤37°C on axillary setting.

You may not qualify if:

  • Women in pregnancy / lactation or plan to be pregnant during the study;
  • The subject has a history of allergy or is allergic with any Ingredient of vaccine, such as egg, ovalbumin;
  • Had serious adverse reactions in previous vaccination, such as allergies, hives, difficult breath, angioneurotic edema or abdominal pain;
  • Autoimmune diseases or immune deficiency;
  • Had asthma, over the past two years, the condition is unstable in need of emergency treatment, hospitalization and oral or intravenous corticosteroids;
  • Diabete (type I or type II) not including gestational diabete;
  • Thyroidectomy history, or treatment because of thyroid diseases in the past 12 months;
  • Over the past 3 years, severe angioneurotic edema, or need treatment in the past 2 years;
  • Severe hypertension and blood pressure is still more than 150/100 mmHg after drug maintenance therapy;
  • coagulation abnormalities diagnosed by doctor (such as lack of coagulation factors, coagulation disorder diseases, platelet abnormality) or coagulation disorder;
  • Malignancy, active or treated tumor without explicitly been cured, or the possibility of a recurrence during the study period;
  • Epilepsy not including alcohol epilepsy of stop drinking in the first 3 years or the simplicity not requiring treatment in the past 3 years;
  • Asplenia, functional asplenia, and any circumstances leading to asplenia or splenectomy;
  • Guillain-Barre syndrome;
  • Had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray to treat allergic rhinitis and corticosteroid treatment of the acute uncomplicated dermatitis) within the past six months;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

CN(1)