Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01040741
First received: December 29, 2009
Last updated: October 4, 2011
Last verified: October 2011
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Purpose
This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.
| Condition | Intervention |
|---|---|
|
Pandemic 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 Focetria |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; 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 with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 7284 |
| Study Start Date: | December 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (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:
- Subject's age in accordance with the approved product label of the country where the study is conducted
- Subjects will be vaccinated with Focetria®, 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: NCT01040741
Locations
| Argentina | |
| Hospital Garrahan | |
| Combate de Los Pozos 1881, Ciudad Autónoma de Buenos Aires, Argentina | |
| Hospital de Ninos "Dr. Ricardo Gutierrez" | |
| Gallo 1330, Ciudad Autónoma de Buenos Aires, Argentina | |
| Hospital Nuestra Señora de la Misericordia | |
| Belgrano 1500, Córdoba, Argentina | |
| Hospital Pediatrico del Niño Jesus | |
| Castro Barros 650 - San Martín, Córdoba, Argentina | |
| Sanatorio Mayo Privado S.A. | |
| Humberto Primo 520, Córdoba, Argentina | |
| Hospital Pediatrico "Dr. Humberto Notti" | |
| Bandera de los Andes 2603 Villa nueva, Guaymallen Mendoza, Argentina | |
| Netherlands | |
| Huisartsenpraktijk Bergentheim | |
| Kanaalweg West 61, Bergentheim, Netherlands, 7691BV | |
| Huisartsenpraktijk Bredero | |
| Brederostraat 2/A, Breda, Netherlands, 4819HH | |
| Saxenburg Groep, Zorgcentrum Aleida Kramer | |
| M.v.d. Thijnensingel 1, Coevorden, Netherlands, 7741GB | |
| Huisartsenpraktijk Dennenlaan | |
| Dennenlaan 56, Emmen, Netherlands, 7822EL | |
| Huisartsenpraktijk de Steenpoort | |
| Prinses Julianastraat 25, Genemuiden, Netherlands, 8281CK | |
| Huisartsenpraktijk Gramsbergen | |
| Voorstraat 3, Gramsbergen, Netherlands, 7783AL | |
| Huisartsenpraktijk Oosterhesselen | |
| Edveensweg 13, Oosterhesselen, Netherlands, 7861AM | |
| Isala Klinieken Zwolle | |
| Groot Wezenland 20, Zwolle, Netherlands, 8011JW | |
Sponsors and Collaborators
Novartis Vaccines
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01040741 History of Changes |
| Other Study ID Numbers: | V111_09OB |
| Study First Received: | December 29, 2009 |
| Last Updated: | October 4, 2011 |
| Health Authority: | The Netherlands: WGBO |
Keywords provided by Novartis:
|
Pandemic influenza A (H1N1) vaccine Adjuvanted |
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 May 19, 2013