Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

This study has been completed.
Sponsor:
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
  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
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: 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 August 20, 2014