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Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

NCT ID: NCT01040741

Last Updated: 2011-10-05

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

7284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-03-31

Brief Summary

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This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

Detailed Description

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Conditions

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Pandemic 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

* Subject's age in accordance with the approved product label of the country where the study is conducted
* Subjects will be vaccinated with Focetria®, 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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Hospital Garrahan

Combate de Los Pozos 1881, Buenos Aires F.D., Argentina

Site Status

Hospital de Ninos "Dr. Ricardo Gutierrez"

Gallo 1330, Buenos Aires F.D., Argentina

Site Status

Hospital Nuestra Señora de la Misericordia

Belgrano 1500, Córdoba Province, Argentina

Site Status

Hospital Pediatrico del Niño Jesus

Castro Barros 650 - San Martín, Córdoba Province, Argentina

Site Status

Sanatorio Mayo Privado S.A.

Humberto Primo 520, Córdoba Province, Argentina

Site Status

Hospital Pediatrico "Dr. Humberto Notti"

Bandera de Los Andes 2603 Villa Nueva, Guaymallen Mendoza, Argentina

Site Status

Huisartsenpraktijk Bergentheim

Kanaalweg West 61, Bergentheim, Netherlands

Site Status

Huisartsenpraktijk Bredero

Brederostraat 2/A, Breda, Netherlands

Site Status

Saxenburg Groep, Zorgcentrum Aleida Kramer

M.v.d. Thijnensingel 1, Coevorden, Netherlands

Site Status

Huisartsenpraktijk Dennenlaan

Dennenlaan 56, Emmen, Netherlands

Site Status

Huisartsenpraktijk de Steenpoort

Prinses Julianastraat 25, Genemuiden, Netherlands

Site Status

Huisartsenpraktijk Gramsbergen

Voorstraat 3, Gramsbergen, Netherlands

Site Status

Huisartsenpraktijk Oosterhesselen

Edveensweg 13, Oosterhesselen, Netherlands

Site Status

Isala Klinieken Zwolle

Groot Wezenland 20, Zwolle, Netherlands

Site Status

Countries

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Argentina Netherlands

Other Identifiers

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V111_09OB

Identifier Type: -

Identifier Source: org_study_id