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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

NCT ID: NCT00973700

Last Updated: 2015-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

784 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

Detailed Description

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Conditions

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Novel 2009 Influenza H1N1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2x7.5adj

Two doses of MF59 adjuvanted (adj) A/H1N1

Group Type EXPERIMENTAL

MF59-eH1N1_f

Intervention Type BIOLOGICAL

MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal

7.5adj_1_8

MF59 adjuvanted (adj) A/H1N1 on days 1 and 8

Group Type EXPERIMENTAL

MF59-eH1N1_f

Intervention Type BIOLOGICAL

MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal

7.5adj_1_22

MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22

Group Type EXPERIMENTAL

MF59-eH1N1_f

Intervention Type BIOLOGICAL

MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal

15_1_22

A/H1N1 on study days 1 and 22

Group Type EXPERIMENTAL

eH1N1_f

Intervention Type BIOLOGICAL

Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

2x15_1_22

Two doses of A/H1N1 (one in each arm) on study days 1 and 22

Group Type EXPERIMENTAL

eH1N1_f

Intervention Type BIOLOGICAL

Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Interventions

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MF59-eH1N1_f

MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal

Intervention Type BIOLOGICAL

eH1N1_f

Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria

* History of serious disease.
* History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
* Known or suspected impairment/alteration of immune function.
* Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.

For additional entry criteria, please refer to protocol.
Minimum Eligible Age

3 Years

Maximum Eligible Age

64 Years

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

Principal Investigators

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Novartis Vaccines

Role: STUDY_DIRECTOR

Novartis Vaccines

Locations

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Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.

San José, , Costa Rica

Site Status

Countries

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Costa Rica

References

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Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.

Reference Type RESULT
PMID: 21285531 (View on PubMed)

Other Identifiers

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V112_04

Identifier Type: -

Identifier Source: org_study_id