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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01037855
First received: December 20, 2009
Last updated: October 4, 2011
Last verified: October 2011
  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:

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 ] [ Designated as safety issue: Yes ]
  • To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037855

Locations
Chile
Clinica Indisa
Av. Santa Maria, Santiago, Chile, 1810
Colombia
Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
10 No 18-75 Bogotá, 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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01037855     History of Changes
Other Study ID Numbers: V110_07OB
Study First Received: December 20, 2009
Last Updated: October 4, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on October 01, 2014