Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

NCT00560066 | Completed Phase 4 Results

• 2 other identifiers: V58P142007-002872-32
• Study Type: interventional
• Target: 1,398
• Locations: 1 country
• Sites: 15

Brief Summary

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.

Conditions

Seasonal Influenza; Vaccine

Keywords

influenza; vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV

  Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.

  From Day 1 up to and including Day 7 post-vaccination

Secondary Outcomes (6)

• Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV

  From Day 1 through Day 7 post-vaccination

• Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV

  From Day 1 through Day 7 post-vaccination

• Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV

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

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

  Three weeks post-vaccination (Day 22)

• Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV

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

Study Arms (2)

cTIV

EXPERIMENTAL

Subjects received one vaccination of cell culture-derived influenza vaccine

Biological: Cell-derived influenza vaccine

TIV

ACTIVE COMPARATOR

Subjects received one vaccination of egg-derived influenza vaccine

Biological: Egg-derived influenza vaccine

Interventions

Cell-derived influenza vaccine BIOLOGICAL

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

cTIV

Egg-derived influenza vaccine BIOLOGICAL

1 dose of 0.5 mL in the deltoid region of the non-dominant arm

TIV

Eligibility Criteria

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

You may qualify if:

• Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
• Able to comply with all study procedures and requirements.

You may not qualify if:

• History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
• Fatal prognosis of an underlying medical condition (\<12 months life expectancy);
• History of Guillain-Barre syndrome;
• Bleeding diathesis or receiving anticoagulants of the coumarin type;
• Hospitalization or residence in a nursing care facility;
• Planned to receive seasonal influenza vaccine outside of this study;
• Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
• Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
• Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the study;
• Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
• Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (15)

Unknown Facility

Balve, Germany

Location

Unknown Facility

Duisberg, Germany

Location

Unknown Facility

Garmisch-Partenkirchen, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Herborn, Germany

Location

Unknown Facility

Illingen, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Laufach, Germany

Location

Unknown Facility

Marburg, Germany

Location

Unknown Facility

Midlum, Germany

Location

Unknown Facility

Olpe, Germany

Location

Unknown Facility

Potsdam, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Unterschleissheim, Germany

Location

Unknown Facility

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Because cTIV was not available, the second part of the study was not performed. In addition, as deviations from protocol procedures and GCP were identified at some sites, data collected for this study were not used to support licensure of cTIV.

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 17, 2016
• Results First Posted: April 18, 2013

Record last verified: 2016-01

Locations

DE (15)