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Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects

NCT00945841•Novartis

View on ClinicalTrials.gov

Summary

This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects eligible for enrollment into this study are male and female adults who are
•1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
•2. Able to comply with all study requirements
•3. In good health as determined by:
•* Medical history;
•* Physical examination;
•* Clinical judgment of the investigator. Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

Exclusion Criteria

•Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
•1. They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
•* Cancer, except for localized skin cancer;
•* Advanced congestive heart failure;
•* Chronic obstructive pulmonary disease (COPD);
•* Autoimmune disease (including rheumatoid arthritis);
•* Acute or progressive hepatic disease;
•* Acute or progressive renal disease;
•* Severe neurological or psychiatric disorder;
•* Severe Asthma.
+19 more criteria

Locations (3)

Site 2

Giessen, Germany

Site 1

Herborn, Germany

Site 3

Marburg, Germany

Key Dates

Start Date

June 1, 2009

Primary Completion Date

June 1, 2009

Completion Date

June 1, 2009

Last Updated

April 7, 2017

Enrollment

126

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

inactivated split influenza vaccine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

Inclusion Criteria

Exclusion Criteria

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults

Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

Yearly Strain Variation Study, 2009/2010