Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00968539
• Date of registration: 27/08/2009
• Primary sponsor: GlaxoSmithKline
• Public title: Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
• Scientific title: Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 to 60 Years
• Date of first enrolment: September 2009
• Target sample size: 130
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00968539
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Belgium

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- A male or female aged 18 to 60 years at the time of the first vaccination.

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol

- Written informed consent obtained from the subject.

- Satisfactory baseline medical assessment by history and physical examination. Stable
health status is defined as the absence of health event satisfying the definition of
a serious adverse event, or a change in an ongoing drug therapy due to therapeutic
failure or symptoms of drug toxicity, within one month prior to enrollment.

- Access to a consistent means of telephone contact, which may be either in the home or
at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy or post-menopause.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of vaccination, and

- has agreed to continue adequate contraception during the entire treatment period and
for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of the study vaccine or planned use during
the study period. Potential subjects in the follow-up phase of a prior
investigational study may be enrolled if the investigator's judgment is that it will
have no effect on safety, reactogenicity, or immunogenicity endpoints in this study,
and that it does not violate the protocol requirements of the prior trial.

- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses
which, although stable, are deemed by the investigator to render the potential
subject unable/unlikely to provide accurate safety reports.

- Presence of an axillary temperature >= 37.5°C, or acute symptoms greater than "mild"
severity on the scheduled date of first vaccination. NOTE: The subject may be
vaccinated at a later date, provided symptoms have resolved, vaccination occurs
within the window specified by the protocol, and all other eligibility criteria
continue to be satisfied.

- Diagnosed with cancer, or treatment for cancer, within the past 3 years.

- Persons with a history of cancer who are disease-free without treatment for 3 years
or more are eligible.

- Persons with a history of histological-confirmed basal cell carcinoma of the skin
successfully treated with local excisions only are excepted and may enroll within 3
years of diagnosis, but other histological types of skin cancer require a 3-year
untreated and disease-free window as above.

- Women who are disease free 3 years or more after the treatment for breast cancer and
receiving long-term prophylactic tamoxifen are excepted and may enroll.

- Any confirmed or suspected immunosuppressive or immunodeficient condition including
history of human immunodeficiency virus (HIV) infection.

- Clinically or virologically confirmed influenza infection within 6 months preceding
the study start.

- Chronic administration of immunosuppressants or other immune modifying drugs within 6
months of study enrolment or planned administration during the study period.

- Receipt of any immunoglobulins and/or any blood products within 3 months of study
enrolment or planned administration of any of these products during the study period.

- Any significant disorder of coagulation or treatment with warfarin derivatives or
heparin. Persons receiving individual doses of low molecular weight heparin outside
of 24 hours prior to vaccination are eligible. Persons receiving prophylactic
antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent
bleeding tendency, are eligible.

- An acute evolving neurological disorder or history of Guillain-Barré syndrome.

- Administration of any vaccines within 30 days before vaccination.

- Any known or suspected allergy to any constituent of influenza vaccines; a history of
anaphylactic-type reaction to any constituent of influenza vaccines; or a history of
severe adverse reaction to a previous influenza vaccine.

- Pregnant or lactating female

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- Any conditions which, in the opinion of the investigator, prevents the subjects from
participating in the study.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza Infection

Intervention(s)

Biological: GSK investigational vaccine GSK2340269A

Biological: GSK investigational vaccine GSK2340272A

Primary Outcome(s)

Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies [Time Frame: At Day 42]

Secondary Outcome(s)

Humoral immune response in terms of HI antibodies [Time Frame: At Day 0, 21, 42, 182 and 364]

Occurrence of serious adverse events and Adverse events of specific interest [Time Frame: During the entire study period (Day 0-364)]

Occurrence of solicited local and general symptoms [Time Frame: During a 7-day (Day 0-6) follow-up after each vaccination]

Occurrence of unsolicited symptoms [Time Frame: During a 21-day (Day 0-20) follow-up period after the first vaccination and during a 63-day (Day 0-20 and Day 21-84) follow-up after the second vaccination]

Serum neutralizing antibody titers [Time Frame: At Day 0, 21, 42, 182 and 364]

Secondary ID(s)

113456

Source(s) of Monetary Support

Please refer to primary and secondary sponsors