Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
This study has been completed.
Sponsor:
Novartis Vaccines
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
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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 June 17, 2013