Reverse Genetic H9N2 Influenza Vaccine Study in Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)

NCT00783926

Influenza Pandemic Influenza

COMPLETED PHASE1

A Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3 Influenza Virus Vaccine Followed by Inactivated A/H7N9 Influenza Virus Vaccine

NCT03581903

Influenza

COMPLETED PHASE1

A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2

NCT01596725

Influenza (Pandemic)

COMPLETED PHASE1

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

NCT01776541

Pandemic H5N1 Influenza

COMPLETED PHASE2

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

NCT01766921

Pandemic H5N1 Influenza

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

50 subjects will be randomized 1:1:1:1:1 to 5 dose groups (10 subjects per treatment group) to receive 2 intramuscular injections of RG reassortant A/H9N2 influenza vaccine on Day 1 and Day 22

Group Type EXPERIMENTAL

Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine

Intervention Type BIOLOGICAL

Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation

Cohort 2

After a safety data review of the first 50 subjects, a further 225 subjects will be randomized 1:1:1:1:1 to 5 dose groups and will receive 2 intramuscular injections of RG reassortant A/H9N2 influenza vaccine on Day 1 and Day 22

Group Type EXPERIMENTAL

Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine

Intervention Type BIOLOGICAL

Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine

Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject is 18 to 49 years of age, inclusive, on the day of screening
* Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgement through collection of medical history and performance of a physical examination
* Subject is physically and mentally capable of participating in the study as determined by the investigator
* Subject agrees to keep a daily record of symptoms for the duration of the study
* If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to first vaccination and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study at least one of the following types of US Food and Drug Administration (FDA) approved birth control measures shall be applied through completion of the Day 181 study visit:

* Hormonal types of birth control (such as implants or birth control pills) or an intrauterine device
* A barrier type of birth control measure (i.e. condoms, diaphragms, cervical caps, etc.)

Exclusion Criteria

* Subject has a history of exposure to H9N2 influenza virus or a history of vaccination with an H9N2 influenza vaccine
* Subject is at potential occupational risk of contracting H9N2 influenza infection (e.g. poultry workers)
* Subject currently suffers from or has a history of a significant (requiring hospitalization or change in intervention in past 6 months)neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome as determined by the investigator
* Subject has a Body Mass Index (BMI) \>= 35
* Subject has hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure \> 159 or diastolic pressure \> 99 while seated and at rest (measurement shall be repeated twice before subject is excluded)
* Subject has clinically significant abnormal laboratory values at screening as determined by the investigator
* Subject tests positive for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAgs) or Hepatitis C Virus (HCV)
* Subject has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the investigator
* Subject has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\> 800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted)
* Subject has a history of severe (required immediate medical life threatening treatment and/or hospitalization) allergic reactions or anaphylaxis as determined by the investigator
* Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the investigator
* Subject has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry
* Subject has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry
* Subject has received any live vaccine within 4 weeks or an inactivated vaccine or a subunit vaccine within 2 weeks prior to vaccination in this study
* Subject has a functional or surgical asplenia
* Subject has a positive urine drug screen (unless the subject is currently prescribed the drug detected by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
* Subject has a known or suspected problem with alcohol or drug abuse as determined by the investigator
* Subject is currently enrolled or has participated in another clinical study involving an investigational products (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study
* Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
* If female, subject is pregnant or lactating at the time of study enrollment
* Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes