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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037855
First Posted: December 23, 2009
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  Purpose
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.

Condition Intervention
Novel Influenza A (H1N1) A New Flu Virus of Swine Origin Other: Non-intervention observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Celtura

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects [ Time Frame: 6 months ]
  • To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination [ Time Frame: 6 Months ]

Enrollment: 4028
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: 6-23 months Other: Non-intervention observational study
Non-intervention observational study
Group 2: 2-8 years Other: Non-intervention observational study
Non-intervention observational study
Group 3: 9-17 years Other: Non-intervention observational study
Non-intervention observational study
Group 4: 18-44 years Other: Non-intervention observational study
Non-intervention observational study
Group 5: 45-60 years Other: Non-intervention observational study
Non-intervention observational study
Group: >60 years Other: Non-intervention observational study
Non-intervention observational study

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
population of children, adolescents, adults and elderly
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037855


Locations
Chile
Clinica Indisa
Av. Santa Maria, Santiago, Chile, 1810
Colombia
Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
Bogota, Colombia
Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI
Calle 66 # 40-07 - Bogotá, Colombia
Hospital local de Yopal E.S.E
Calle 9 No. 24-37 - Yopal, Casanare, Colombia
Clinica del Country
Carrera 16 No. 82-57 Bogotá, Colombia
Hospital Universitario Infantil San José
Carrera 52 No. 67A-71 - Barrios Unidos - Bogotá, Colombia
CAIMED - Centro de Atencion e Investigación Medica
Cra. 42 A No. 17-50, Colombia
Germany
Augustenburger Platz 1, Berlin, Germany
Switzerland
Policlinique Médicale Universitaire
Rue du Bugnon 44, CH-1011 Lausanne, Switzerland
Institute of Social and Preventive Medicine, Division of Communicable Diseases
Hirschengraben 84, CH-8001 Zürich, Switzerland
Sponsors and Collaborators
Novartis Vaccines
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01037855     History of Changes
Other Study ID Numbers: V110_07OB
First Submitted: December 20, 2009
First Posted: December 23, 2009
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Vaccines ):
Swine Flu H1N1 vaccine
Adjuvanted flu cell culture derived

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs