NCT01040741

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

December 29, 2009

Last Update Submit

October 4, 2011

Conditions

Pandemic Influenza A (H1N1)A New Flu Virus of Swine Origin

Keywords

Pandemic influenza A (H1N1) vaccineAdjuvanted

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 Months

Secondary Outcomes (1)

  • 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.

    6 months

Study Arms (6)

Group 1: 6-23 months

Other: Non-intervention observational study

Group 2: 2-8 years

Other: Non-intervention observational study

Group 3: 9-17 years

Other: Non-intervention observational study

Group 4: 18-44 years

Other: Non-intervention observational study

Group 5: 45-60 years

Other: Non-intervention observational study

Group: >60 years

Other: Non-intervention observational study

Interventions

Non-intervention observational studyOTHER

Non-intervention observational study

Group 1: 6-23 monthsGroup 2: 2-8 yearsGroup 3: 9-17 yearsGroup 4: 18-44 yearsGroup 5: 45-60 yearsGroup: >60 years

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of children, adolescents, adults and elderly

You may qualify if:

  • 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

You may not qualify if:

  • Received any prior H1N1 vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Garrahan

Combate de Los Pozos 1881, Buenos Aires F.D., Argentina

Location

Hospital de Ninos "Dr. Ricardo Gutierrez"

Gallo 1330, Buenos Aires F.D., Argentina

Location

Hospital Nuestra Señora de la Misericordia

Belgrano 1500, Córdoba Province, Argentina

Location

Hospital Pediatrico del Niño Jesus

Castro Barros 650 - San Martín, Córdoba Province, Argentina

Location

Sanatorio Mayo Privado S.A.

Humberto Primo 520, Córdoba Province, Argentina

Location

Hospital Pediatrico "Dr. Humberto Notti"

Bandera de Los Andes 2603 Villa Nueva, Guaymallen Mendoza, Argentina

Location

Huisartsenpraktijk Bergentheim

Kanaalweg West 61, Bergentheim, 7691BV, Netherlands

Location

Huisartsenpraktijk Bredero

Brederostraat 2/A, Breda, 4819HH, Netherlands

Location

Saxenburg Groep, Zorgcentrum Aleida Kramer

M.v.d. Thijnensingel 1, Coevorden, 7741GB, Netherlands

Location

Huisartsenpraktijk Dennenlaan

Dennenlaan 56, Emmen, 7822EL, Netherlands

Location

Huisartsenpraktijk de Steenpoort

Prinses Julianastraat 25, Genemuiden, 8281CK, Netherlands

Location

Huisartsenpraktijk Gramsbergen

Voorstraat 3, Gramsbergen, 7783AL, Netherlands

Location

Huisartsenpraktijk Oosterhesselen

Edveensweg 13, Oosterhesselen, 7861AM, Netherlands

Location

Isala Klinieken Zwolle

Groot Wezenland 20, Zwolle, 8011JW, Netherlands

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2009

First Posted

December 30, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

AR(6)NL(8)