WithdrawnNCT01676675Updated Mar 15, 2013

A Phase I Clinical Trial With Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults

A Phase 1 interventional study of 7.5μg /0.5ml and 15.0μg /0.5ml in Healthy, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Withdrawn at 1 site in China. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-03-15.

Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 12 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Healthy

Browse trials for

Keywords

whole virus
inactivated
influenza
H5N1 vaccine
safety
immunogenicity

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

Browse Influenza, Human studies →

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion Criteria for the first dose:

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;
Received immune globulin in three months before study;
Received other experimental drugs in 30 days before study;
Received live attenuated vaccine in 30 days before study;
Receiving subunit or inactivated vaccines in 14days before study, such as pneumococcal vaccine or allergy treatment;
In prevention or treatment of the anti-TB (antituberculosis) now;
Had fever (axillary temperature ≥ 38.0℃) 3 days before vaccination or had any acute illness in the past five days requiring systemic antibiotics or antiviral therapy);
The subject is unable to comply with the study requirements because of psychology, or had mental illness or dual-stage affective psychosis not well controlled within the past two years or had psychology in medication and suicidal tendency in the past five years;
According to the researcher, contrary to the study protocol or effect signed informed consent due to a variety of medical, psychological, social conditions, occupational factors or other conditions.

Exclusion Criteria for the second dose:

Had any vaccination-related Grade 3 or more adverse reactions in 72 hours after first vaccination;
Any situation meets the exclusion criteria stated in the exclusion criteria for first dose;
Had serious adverse reactions caused by the study vaccination.
Acute infection;
Any condition the investigator believed may affect the evaluation of the vaccine.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 0 participants (actual)

Study arms

Experimental
7.5μg/0.5ml in subjects(12-17 years old)
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
Experimental
15μg/0.5ml in subjects(12-17 years old)
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
Experimental
30μg/0.5ml in subjects(12-17 years old)
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
Experimental
7.5μg/0.5ml in subjects(18-60 years old)
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
Experimental
15μg/0.5ml in subjects(18-60 years old)
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
Experimental
30μg/0.5ml in subjects(18-60 years old)
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
Placebo comparator
0/0.5ml in adolescents (12-17 years old)
0/0.5ml placebo in 30 adolescents aged 12-17 years old on day 0, 21
Biological: 0/0.5ml placebo
Placebo comparator
0/0.5ml in adults(18-60 years old)
0/0.5ml placebo in 30 adults aged 18-60 years old on day 0, 21
Biological: 0/0.5ml placebo

Interventions

Biological7.5μg /0.5ml
whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval
Biological15.0μg /0.5ml
whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval
Biological30.0μg /0.5ml
whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval
Biological0/0.5ml placebo
0/0.5ml placebo, two doses, 21 days interval

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months after second dose (±14 days)

Secondary outcomes

abnormal change of hematological examination and the function of liver and kidney after first dose
abnormal change of hematological examination and the function of liver and kidney 3 days after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Time frame: 3 days after first dose
abnormal change of hematological examination and the function of liver and kidney after second dose
abnormal change of hematological examination and the function of liver and kidney 3 days after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Time frame: 3 days after second dose

Study locations

1 site

Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu 210009, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01676675
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Collaborators: Wuhan Institute of Biological Products Co., Ltd
Responsible party: Sponsor
First posted: Aug 31, 2012
Start date: Aug 2012
Primary completion: Jan 2013 (estimated)
Completion: Mar 2013 (estimated)
Last update: Mar 15, 2013

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

Jiangsu Province Centers for Disease Control and Prevention

Start the discussion