Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)

Influenza Clinical Trial

Official title:

Single Blind, Randomized, Actively Controlled Phase 1/2 Study to Compare the Safety and Immunogenicity of a Split Virus, Vero Cell Derived, Seasonal Influenza Vaccine (VCIC) With a Licensed, Egg Derived, Split Virus, Seasonal Influenza Vaccine (EIV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424086
• Other study ID #: 720601
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 17, 2007
• Last updated: October 7, 2015
• Start date: January 2007
• Est. completion date: September 2007

Study information

• Verified date: January 2008
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenGermany: Paul-Ehrlich-InstitutPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the safety, tolerability and immunogenicity of a Split Virus, Vero Cell derived, Seasonal Influenza Vaccine (VCIV) in comparison to a Licensed Egg Derived, Split Virus, Seasonal Influenza Vaccine (EIV) in healthy subjects 18 years of age and older.

Approximately 1000 subjects will be randomly assigned in a 3:1 ratio to receive a single injection of VCIV or EIV. Subjects will be monitored for 180 days following vaccination for occurrence of adverse reactions and for antibody response to the vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Male and female subjects who

• Are 18 to 49 years of age (inclusive) on the day of screening (Stratum A)

• Are 50 years of age or older on the day of screening (Stratum B)

• Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry

• Are clinically healthy (in a physical condition such that the physician would have no reservations administering influenza vaccine outside the scope of a clinical study)

• Are physically and mentally capable of participating in the study

• Agree to keep a daily record of symptoms

• If female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate 2 types of the following FDA approved birth control measures through 60 days after vaccination:

• Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, AND

• An additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.)

Exclusion Criteria:

Subjects who

• Have previously been vaccinated against influenza with vaccine formulated for the 2006/2007 influenza season

• Have an oral temperature >=37.5°C at the time of vaccination on Day 0 (see note below)

• Have Type I diabetes

• Have a Body Mass Index >35

• Have hypertension at screening (with or without medication) that is graded as greater than Stage 1 defined as a systolic pressure >159 or diastolic pressure >99 while seated and at rest (measurement may be repeated twice before subject is absolutely excluded)

• Have clinically significant abnormal clinical laboratory values at screening

• Have clinically significant electrocardiographic abnormalities at screening

• Test positive for Human Immunodeficiency Virus(HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)

• Have a history of cardiovascular disease that required hospitalization

• Have a history of immunodeficiency or autoimmune diseases

• Have a history of arthritis (joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months

• Suffer from active neoplastic disease or have a history of hematologic malignancy

• Suffer from a disease or are undergoing a form of treatment 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

• Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis)

• Have received any vaccination within 2 weeks prior to vaccination in this study

• Have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study

• Have donated blood or plasma within 30 days prior to vaccination in this study

• Have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications)

• Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating

• Have a positive urine drug screen (unless the detected drug is currently prescribed by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)

• Were administered an investigational drug within 6 weeks prior to study entry

• Are concurrently participating in a clinical study that Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)includes the administration of an investigational product

• Are a member of the team conducting this study

• Are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator

• If female, are pregnant or lactating.

NOTE: If all other inclusion/exclusion criteria are met, a subject with a temperature >=37.5°C on Day 0 may be included in the study at a repeat visit provided:

1. They do not have an oral temperature >=37.5°C at the repeat visit,

2. The repeat visit is no more than 5 calendar days after the initial Day 0 visit,

3. The repeat visit is no more than 21 calendar days after all other screening procedures are completed,

4. Subjects are still being recruited at the study site.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Inactivated seasonal influenza vaccine (split virus, vero cell derived)

• Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]

Locations

Country	Name	City	State
Austria	Kinemed	Graz
Austria	Universitaetsklinik f. Klinische Pharmakologie, Allgemeines Krankenhaus Wien (University Hospital for Clinical Pharmacology, General Hospital of Vienna)	Vienna
Germany	MDS Pharma Services Germany GmbH	Hamburg
Germany	Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)	Mainz
Germany	Harrison Clinical Research	Munich
Poland	Zespol Przychodni Specjalistycznych "DIAB-END-COR" Sp. z o.o.	Krakow
Poland	PANTAMED Sp. z o.o.	Olsztyn
Poland	Niepubliczny Zaklad Opieki Zdrowotnej, Osrodek Zdrowia w Lipsku	Zamosc

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of Vero cell derived vaccine in comparison to egg-derived vaccine in healthy subjects in two age strata: 18 to 49 years, and 50 years of age and older
Primary	To assess the immunogenicity of Vero cell derived vaccine in comparison to egg-derived vaccine for subjects in two age strata: 18 to 49 years of age and 50 years of age and older