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Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011

A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of Begrivac®, Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 When Administered to Adult and Elderly Subjects

NCT01147081•Novartis Vaccines

View on ClinicalTrials.gov

Summary

Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.

Detailed Description

At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples were collected at day 1 (baseline, before the vaccination) and at day 22 (three weeks after the vaccination). Sera were tested by Hemagglutination Inhibition (HI) assay. Safety was assessed until 3 weeks after the vaccination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
•2. Individuals able to comply with all the study requirements;
•3. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
•Written 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

•1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
•2. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
•1. Cancer, except for localized skin cancer;
•2. Advanced congestive heart failure;
•3. Chronic obstructive pulmonary disease (COPD);
•4. Autoimmune disease (including rheumatoid arthritis);
•5. Acute or progressive hepatic disease;
•6. Acute or progressive renal disease;
•7. Severe neurological or psychiatric disorder;
•8. Severe asthma;
+22 more criteria

Locations (3)

Hamburg, Hamburg, Germany

Universität Rostock/Medizinische Fakultät

Ernst-Heydemann Str. 6, Rostock, Germany

Magdeburg, Saxony-Anhalt, Germany

Key Dates

Start Date

June 1, 2010

Primary Completion Date

July 1, 2010

Completion Date

July 1, 2010

Last Updated

January 5, 2012

Enrollment

142

ACTUAL participants

Conditions

Seasonal Influenza

Interventions

BEGRIVAC

BIOLOGICAL

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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: January 5, 2012Data 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 2010/2011

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

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