Trial record 10 of 134 for:    novel influenza a (h1n1)

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
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 April 17, 2014