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Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season

NCT ID: NCT01633749

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-07-31

Brief Summary

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Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.

Detailed Description

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An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.

Conditions

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Prophylaxis of Influenza

Keywords

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Influenza Vaccine CHMP criteria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Trivalent influenza subunit vaccine Influvac

3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Group Type EXPERIMENTAL

Trivalent influenza subunit vaccine Influvac

Intervention Type BIOLOGICAL

3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Interventions

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Trivalent influenza subunit vaccine Influvac

3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-SLV201, trivalent influenza subunit vaccine, Influvac

Eligibility Criteria

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Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.

Exclusion Criteria

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination.
3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
5. Having any condition which suppresses the immune system and autoimmune disorders.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Biologicals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serge van de Witte, PhD

Role: STUDY_DIRECTOR

Abbott Healthcare Products BV

Locations

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Site Reference ID/Investigator# 74593

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-001032-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-567

Identifier Type: -

Identifier Source: org_study_id