Trials Sponsors Conditions Drugs Pricing

Conditions

Pandemic H5N1 Influenza

Keywords

Pandemic InfluenzaH5N1Adults and Elderlyantigen dose

Outcome Measures

Primary Outcomes (3)

Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined.
43 days
Solicited local reactions: ecchymosis, erythema, induration, swelling and pain at injection site.
6 weeks
Solicited systemic reactions: headache, arthralgia, chills, fatigue, malaise, myalgia, nausea, sweating and fever as measured by axillary temperature for Day 1 through 7 and Day 22 to 28 of the study.
6 weeks

Secondary Outcomes (5)

Geometric mean titers/area (GMTs/GMAs) on each blood sampling days as determined by HI and SRH, and the applicable geometric mean ratios.
6 weeks
Percentage of subjects achieving seroconversion or significant increase in antibody titer on each post-vaccination blood sampling days, as measured by HI and SRH.
6 weeks
Percentage of subjects achieving an HI titer ≥40/ SRH area ≥25mm² on each blood sampling days.
6 weeks
Immunogenicity, as determined by HI or SRH, will be assessed according to age-appropriate CHMP criteria (CPMP/BWP/214/96).
6 weeks
Immunogenicity according to CBER criteria in terms of hemagglutination inhibition test in non-elderly adult and elderly subjects separately, for all post-vaccination blood sampling days and the immunogenicity according to microneutralization test
6 weeks

Study Arms (2)

H5N1 pandemic Influenza vaccine 3.75µg

ACTIVE COMPARATOR

Biological: H5N1 pandemic Influenza vaccine 3.75µg

H5N1 pandemic Influenza vaccine 7.5µg

ACTIVE COMPARATOR

Biological: H5N1 pandemic Influenza vaccine 7.5µg

Interventions

H5N1 pandemic Influenza vaccine 3.75µgBiological

2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen

H5N1 pandemic Influenza vaccine 3.75µg

H5N1 pandemic Influenza vaccine 7.5µgBiological

2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 7.5µg H5N1 antigen

H5N1 pandemic Influenza vaccine 7.5µg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females 18 yrs of age and above on the day of enrollment.
Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator

Sponsors & Collaborators

Novartis Vaccines
Industrylead

Study Sites (12)

NZOZ Centrum Zdrowia "Blonie"

Bydgoszcz, Poland

Prakytka Lekarzy Rodzinnych "Salus"

Katowice, Poland

Szpital Internistyczny

Krakow, Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy im.

Krakow, Poland

Samodyielny Publiczny ZOZ

Lubartów, Poland

NZOZ Praktyka Lekarza Rodzinnego "Eskulap"

Lubin, Poland

Gazi Universitesi Tip Fakultesi

Ankara, Turkey (Türkiye)

Related Publications (1)

Czajka H, Unal S, Ulusoy S, Usluer G, Strus A, Sennaroglu E, Guzik J, Topeli Iskit A, Dargiewicz A, Musial D, Caylan R, Dziduch J, Eskioglu E, Hasiec B, Cwinarowiczliwa E, Belli R, Abdel-Messih IA, Beygo J, Fragapane E. A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects. J Prev Med Hyg. 2012 Sep;53(3):136-42.
PMID: 23362618DERIVED

Study Officials

Novartis Vaccines
Novartis Vaccines
STUDY CHAIR

Enrollment

722 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

September 2009

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study or who do not consent to the retention of the subject's serum samples after study completion.
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
Individuals who have had influenza vaccine or documented suspected influenza disease within 6 months prior to Day 1.
Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1. "Laboratory-confirmed" includes:
Positive serology result
Positive viral culture
Positive rapid antigen test
"Suspected" influenza disease includes: subjects with influenza-like illness within the past 6 months with a household/intimate contact with "laboratory-confirmed" influenza disease
Individuals experiencing any acute disease or infection requiring systemic antibiotic or antiviral therapy within 6 days before vaccination (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), chicken protein.
History of any serious disease, such as:
a. Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment) b. autoimmune disease (including rheumatoid arthritis) except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years; c. diabetes mellitus type I; d. poorly controlled diabetes mellitus type II; e. diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas, or infections; f. advanced arteriosclerotic disease; g. severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; h. acute or progressive hepatic disease; i. acute or progressive renal disease; j. medically significant congestive heart failure; k. history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome)
Known or suspected impairment/alteration of immune function, including:
Receipt of immunosuppressive therapy such as oral or systemic corticosteroids, (use of inhaled, intranasal, or topical corticosteroids is allowed) or cancer chemotherapy within 60 days prior to Visit 1
+22 more criteria

Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 Influenza Vaccines Containing 2 Doses of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (2)

H5N1 pandemic Influenza vaccine 3.75µg

H5N1 pandemic Influenza vaccine 7.5µg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (2)

H5N1 pandemic Influenza vaccine 3.75µg

H5N1 pandemic Influenza vaccine 7.5µg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations