Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

NCT00492063 | Completed Phase 3 Results

• 1 other identifier: V58P4
• Study Type: interventional
• Target: 2,654
• Locations: 1 country
• Sites: 5

Brief Summary

The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.

Conditions

Influenza

Keywords

safety; immunogenicity; non-inferiority; MDCK; cell culture-derived; subunit influenza vaccine; influenza prevention

Outcome Measures

Primary Outcomes (3)

• Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines

  Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70% in the ≥18 to ≤60 years of age group or \>60% in the ≥61 years of age group.

  Before vaccination (day 1) and three weeks after vaccination (day 22)

• Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV

  Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer \<10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is \>40% in the ≥18 to ≤60 years of age group or \>30% in the ≥61 years of age group.

  Three weeks after vaccination (day 22)

• Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV

  Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is \>2.5 in the ≥18 to ≤60 years of age group or \>2.0 in the ≥61 years of age group.

  Three weeks after vaccination (day 22)

Secondary Outcomes (1)

• Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination

  Up to 7 days postvaccination

Study Arms (2)

Cell culture-derived influenza vaccine (cTIV)

EXPERIMENTAL

Biological: Cell culture-derived trivalent subunit influenza vaccine (cTIV)

Egg-derived influenza virus vaccine (TIV)

ACTIVE COMPARATOR

Biological: Egg-derived trivalent subunit influenza vaccine (TIV)

Interventions

Cell culture-derived trivalent subunit influenza vaccine (cTIV) BIOLOGICAL

One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle

Cell culture-derived influenza vaccine (cTIV)

Egg-derived trivalent subunit influenza vaccine (TIV) BIOLOGICAL

One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle

Egg-derived influenza virus vaccine (TIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 60 years of age (first age group) OR over 60 years of age (second age group)
• 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
• residence in the study area
• in good health as determined by:
• medical history,
• physical examination,
• clinical judgment of the investigator.

You may not qualify if:

• unable or unwilling to give written informed consent to participate in the study
• suffering from an acute infectious disease
• any serious disease such as:
• 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),

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (5)

Wojewódzki Szpital Dzieciecy

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

Location

N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o.

Os. Jagiellonskie 1, Kraków, 31-832, Poland

Location

Praktyka Grupowa Lekarzy POZ "Familia"

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

Location

Szpital Jana Pawła II

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

Location

Centrum Farmakologii Klinicznej

Krakow, 30-969, Poland

Location

Related Publications (1)

• Szymczakiewicz-Multanowska A, Groth N, Bugarini R, Lattanzi M, Casula D, Hilbert A, Tsai T, Podda A. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis. 2009 Sep 15;200(6):841-8. doi: 10.1086/605505.

  PMID: 19673651 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: September 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: May 1, 2005
• Last Updated: January 1, 2016
• Results First Posted: February 21, 2013

Record last verified: 2015-12

Locations

PL (5)