NCT00306527

Brief Summary

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,235

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

September 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

January 11, 2013

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

March 22, 2006

Results QC Date

December 6, 2012

Last Update Submit

August 2, 2019

Conditions

Influenza

Keywords

Influenzaadult/elderlyflu cell culturevaccine

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine

    To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .

    Day 1 to Day 7 postvaccination

Secondary Outcomes (5)

  • Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine

    Up to 6 months postvaccination

  • Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects

    Day 22 postvaccination

  • Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects

    Day 22 postvaccination

  • Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.

    Day 22 postvaccination

  • Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.

    Day 22 postvaccination

Study Arms (8)

cTIV\cTIV (adults)

ACTIVE COMPARATOR

Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.

Biological: Cell culture derived influenza vaccine

cTIV\TIV (adults)

ACTIVE COMPARATOR

Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Biological: egg-derived influenza subunit vaccine

cTIV\cTIV (elderly)

ACTIVE COMPARATOR

Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.

Biological: Cell culture derived influenza vaccine

cTIV\TIV (elderly)

ACTIVE COMPARATOR

Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Biological: egg-derived influenza subunit vaccine

TIV\TIV (adults)

ACTIVE COMPARATOR

Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Biological: egg-derived influenza subunit vaccine

TIV\cTIV (adults)

ACTIVE COMPARATOR

Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.

Biological: Cell culture derived influenza vaccine

TIV\TIV (elderly)

ACTIVE COMPARATOR

Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Biological: egg-derived influenza subunit vaccine

TIV\cTIV (elderly)

ACTIVE COMPARATOR

Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.

Biological: Cell culture derived influenza vaccine

Interventions

Cell culture derived influenza vaccineBIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

TIV\cTIV (adults)TIV\cTIV (elderly)cTIV\cTIV (adults)cTIV\cTIV (elderly)
egg-derived influenza subunit vaccineBIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

TIV\TIV (adults)TIV\TIV (elderly)cTIV\TIV (adults)cTIV\TIV (elderly)

Eligibility Criteria

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

You may qualify if:

  • to \< 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
  • Mentally competent to understand the nature, the scope and the consequences of the study
  • Able and willing to give written informed consent prior to study entry
  • Available for all the visits scheduled in the study
  • in good health as determined by:
  • Medical history related to the previous six months,
  • Physical examination,
  • Clinical judgment of the investigator.

You may not qualify if:

  • Unwilling or unable to give written informed consent to participate in the study
  • Currently experiencing an acute infectious disease
  • Any serious disease such as, for example:
  • Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
  • Autoimmune disease (including rheumatoid arthritis)
  • Advanced arteriosclerotic disease or complicated diabetes mellitus
  • Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
  • Acute or progressive hepatic disease
  • Acute or progressive renal disease
  • Congestive heart failure
  • Surgery planned during the study period
  • Bleeding diathesis
  • History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
  • Known or suspected impairment/alteration of immune function resulting from:
  • Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Wojewódzki Szpital Dzieci_cy

Ul. Langiewicza 2, Kielce, 25-381, Poland

Location

Centrum Bada_ Farmakologii Klinicznej

Ul. Ujastek 3, Krakow, 30-969, Poland

Location

NZOZ Jagiello_skie

Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1, Kraków, 31-832, Poland

Location

NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.

Pl. Sikorskiego 6a, Kraków, 31-115, Poland

Location

Szpital Jana Pawła II, Oddz. Neuroinfekcji

Ul. Pr_dnicka 80, Kraków, 31-202, Poland

Location

Related Publications (1)

  • Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.

    PMID: 22418809RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Study Officials

  • Novartis Vaccines and Diagnostics

    Novartis Vaccines

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 24, 2006

Study Start

September 1, 2005

Primary Completion

December 1, 2005

Study Completion

April 1, 2006

Last Updated

August 14, 2019

Results First Posted

January 11, 2013

Record last verified: 2019-08

Locations

PL(5)