NCT01147081

Brief Summary

Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

3 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

June 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

June 17, 2010

Last Update Submit

January 4, 2012

Conditions

Seasonal Influenza

Keywords

Influenza vaccineVaccine

Outcome Measures

Primary Outcomes (1)

  • Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 1 and on Day 22, and evaluation of safety of Begrivac

    22 days (-1/+5)

Study Arms (1)

Arm 1

EXPERIMENTAL
Biological: BEGRIVAC

Interventions

BEGRIVACBIOLOGICAL

126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine)

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
  • Individuals able to comply with all the study requirements;
  • Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
  • Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

You may not qualify if:

  • Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
  • Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
  • Cancer, except for localized skin cancer;
  • Advanced congestive heart failure;
  • Chronic obstructive pulmonary disease (COPD);
  • Autoimmune disease (including rheumatoid arthritis);
  • Acute or progressive hepatic disease;
  • Acute or progressive renal disease;
  • Severe neurological or psychiatric disorder;
  • Severe asthma;
  • Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, Polymyxin B;
  • Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
  • receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
  • receipt of immunostimulants;
  • receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Hamburg, Hamburg, 20359, Germany

Location

Universität Rostock/Medizinische Fakultät

Ernst-Heydemann Str. 6, Rostock, 18057, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Related Publications (1)

  • Loebermann M, Anders G, Brestrich G, Fritzsche C, Klammt S, Borso D, Frimmel S, Riebold D, Reisinger EC. Safety and immunogenicity of a trivalent single dose seasonal influenza vaccine containing pandemic A(H1N1) antigen in younger and elderly subjects: a phase III open-label single-arm study. Vaccine. 2011 Feb 1;29(6):1228-34. doi: 10.1016/j.vaccine.2010.11.092. Epub 2010 Dec 15.

    PMID: 21167116DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Vaccines

    Novartis Vaccines

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

DE(3)