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Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

NCT ID: NCT01037855

Last Updated: 2017-03-14

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

Total Enrollment

4028 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-01-31

Brief Summary

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This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.

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Detailed Description

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Conditions

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Novel Influenza A (H1N1) A New Flu Virus of Swine Origin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: 6-23 months

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Group 2: 2-8 years

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Group 3: 9-17 years

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Group 4: 18-44 years

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Group 5: 45-60 years

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Group: >60 years

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Interventions

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Non-intervention observational study

Non-intervention observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 6 months
* Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, independently of this study.
* Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion Criteria

• Received any prior H1N1 vaccination
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica Indisa

Av. Santa Maria, Santiago Metropolitan, Chile

Site Status

Fundación Universitaria de Ciencias de Salud- Hospital San José Calle

Bogotá, , Colombia

Site Status

Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI

Calle 66 # 40-07 - Bogotá, , Colombia

Site Status

Hospital local de Yopal E.S.E

Calle 9 No. 24-37 - Yopal, Casanare, , Colombia

Site Status

Clinica del Country

Carrera 16 No. 82-57 Bogotá, , Colombia

Site Status

Hospital Universitario Infantil San José

Carrera 52 No. 67a-71 - Barrios Unidos - Bogotá, , Colombia

Site Status

CAIMED - Centro de Atencion e Investigación Medica

Cra. 42 A No. 17-50, , Colombia

Site Status

Augustenburger Platz 1, State of Berlin, Germany

Site Status

Policlinique Médicale Universitaire

Rue Du Bugnon 44, Ch-1011 Lausanne, Switzerland

Site Status

Institute of Social and Preventive Medicine, Division of Communicable Diseases

Hirschengraben 84, Ch-8001 Zürich, Switzerland

Site Status

Countries

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Chile Colombia Germany Switzerland

Other Identifiers

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V110_07OB

Identifier Type: -

Identifier Source: org_study_id

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