NL-OMON36678
Completed
Not Applicable
A Phase 1, randomized, double-blind, controlled trial to evaluate the safety and immunogenicity of increasing intranasal doses or of three intramuscular doses of the adjuvant Gram-positive Enhancer Matrix (GEM) administered with a standard dose of trivalent inactivated influenza vaccine (TIV) antigens, compared to a standard dose of TIV antigens administered either intranasally or intramuscularly in healthy adult volunteers; followed by a randomized, double-blind, controlled evaluation of safety - FluGem in healthy adult and elderly volunteers
Mucosis0 sites134 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- griep vaccination
- Sponsor
- Mucosis
- Enrollment
- 134
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18 \- 49 years inclusive ;OR ;• Male or female aged 65 years or older ;• Able to give written informed consent to participate;• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and to be contacted by telephone throughout the follow\-up period.;• Healthy\- Subjects must be free of any clinically significant disease, as determined by medical history, physical examination, vital signs, and safety laboratory examinations at baseline;• A Body Mass Index (BMI) between 18 and 32, inclusive. BMI \= weight (kg)/height2 (m2\). ;• Subjects\* clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator and within allowed expanded range supplied by sponsor. Subject\*s liver function test results (ie, AST, ALT) must not be elevated above the normal limits at Screening;• The Screening 12 lead ECG conduction intervals must be within gender specific normal range (QTc males \* 430 msec, PR interval \* 200 msec).;• Vital sign measurements (taken after \~3 minutes in a supine position) must be within the following ranges: (Individuals with values outside (or indicate lower or higher) of these ranges may be enrolled if clinically acceptable to the investigator and sponsor.) ;o oral body temperature, between 35\.0\*C and 37\.5\*C;o systolic blood pressure, 90 to 140 mm Hg;o diastolic blood pressure, 45 to 90 mm Hg;o pulse rate, 40 to 100 bpm;• ;• ;• Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose. and / or should fulfill one of the following criteria:;A At least one year post\-menopausal;;B. Surgically sterile;C Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the Investigator (e.g., intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination, throughout study duration and until 28 days after vaccination.
Exclusion Criteria
- •Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of a new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening ;• Receipt of a 2010/2011 influenza vaccine in the vaccination season 2010/2011\.;• HI titers against the vaccine strains \>\= 1:10 for 2 or more strains;• Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.;• Subjects positive for Hematuria on screening urinalysis.;• Positive serology for HIV\-1 or HIV\-2\.;• Cancer, or treatment for cancer, within 3 years, excluding basal cell carcinoma or squamous cell carcinoma, which is allowed.;• Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus.;• Presently receiving or history of receiving, during the preceding 3\-month period, any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulins, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Topical corticosteroids will be allowed. ;• Receipt or planned administration of a non\-study vaccine within 30 days prior to vaccination and during the study. If for a subject included in the study, immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) becomes necessary, the subject will remain in the study provided the tetanus vaccine is administered up to 8 days before the second dose of the study vaccine or at least 8 days after a dose of study vaccine. Administration of study vaccine can be delayed if a non\-study vaccine has been administered and will be given as soon as acceptable, as described above.;• Positive history of illicit drug or alcohol abuse within the previous 6 months or positive drug or alcohol screen.;• History of anaphylactic type reaction to injected vaccines.;• History of drug or chemical abuse in the year before the study.;• Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or more than 4 times in the past year.;• Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period.;• Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period.;• Loss of blood outside the limits of Sanquin within 3 months prior to screening. ;• Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.;• Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical examination) with or without fever, or a fever \>38ºC. Study vaccine can be administered to persons with a minor illness, such as diarrhea. However, in subjects suffering from mild upper respiratory tract infection with or without low\-grade fever, vaccination must be delayed until the subject has recovered.;• Any condition that, in the Investigator\*s opinion, might interfere with the primary study objectives.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Study of egg-derived influenza vaccine and cell culture-derived influenza vaccine in healthy adult volunteersDiseases of the blood and blood -forming organs and certain disorders involving the immune mechanismKCT0001240SK Chemicals100
Not yet recruiting
Not Applicable
A phase-I, double-blind, randomized, controlled study on the tolerability and early efficacy of hLF1-11 in hospitalized patients with bacteremia due to Staphylococcus epidermidis.NL-OMON31208AM-Pharma B.V.20
Active, not recruiting
Not Applicable
Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.EUCTR2011-002225-22-DEGlaxoSmithKline Biologicals
Active, not recruiting
Not Applicable
Examine safety & immune responses of GSK 257049 vaccine when administered to infants living in a malaria-endemic regioHealthy volunteers (Primary immunization against Plasmodium falciparum malaria).Therapeutic area: Diseases [C] - Parasitic Diseases [C03]EUCTR2015-001538-25-Outside-EU/EEAGlaxoSmithKline Biologicals214
Completed
Phase 1
A study to assess the safety and tolerability of PH46A in healthy volunteers, to measure drug levels in these subjects and to determine the effect of food on the drug's absorptiolcerative colitisDigestive SystemUlcerative colitisISRCTN90725219Trino Therapeutics (Ireland)96