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Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) (Biological); Non-adjuvanted trivalent subunit influenza vaccine (TIV) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Vaccines

Official(s) and/or principal investigator(s):
Novartis Vaccines, Study Chair, Affiliation: Novartis Vaccines

Summary

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

Clinical Details

Official title: A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV

Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS

Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS

Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)

Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS

Percentage of Subjects With HI Titers ≥40 Against Homologous Strains

Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains

Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains

Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains

Secondary outcome:

Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS

Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS

Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS

Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS

Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS

Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS

Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS

Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS

Persistence of GMTs Against Homologous and Heterologous Strains

Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains

Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups

Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups

Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups

All Cause Mortality Rate, Across Vaccine Groups

Number of Subjects Reporting Solicited Adverse Events Following Vaccination

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures. Exclusion Criteria: 1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study. 2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study. 3. Known or suspected impairment/alteration of immune function. 4. Individuals with a known bleeding diathesis. 5. History of Guillain-Barré syndrome. 6. Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide). 7. 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. 8. Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine. 9. Individuals who had received vaccination against seasonal influenza in the previous 6 months. 10. Individuals with oral temperature ≥38. 0°C (≥100. 4°F) on day of study vaccination. 11. Individuals with history of substance or alcohol abuse within the past 2 years. 12. Individuals providing consent who did not consent to the retention of their serum samples after study completion. 13. Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject. 14. Subjects from whom blood could not be drawn at visit 1.

Locations and Contacts

203, Health Research International HRI, Clayton ciudad del Saber Edificio 118, Panama

205, Medical and Research Center Calle 53 Urbanizacion Marbella, Consultorios Royal Center 108, Panama

110, San Juan de Dios Hospital, 2772 Roxas Blvd, Pasay City 1300, Philippines

111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard, Quezon City 1102, Philippines

301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A, Phoenix, Arizona 85253, United States

209, Centro de Investigacion CAFAM, Avenida Carrera 68, Bogota, Colombia

206, Centro de Atencion e Investigacion Medica CAIMED, Carrera 42A, Bogota 1750, Colombia

213, Centro de Atencion e Investigacion Medica CAIMED, Carrera 42A, Bogota 1750, Colombia

207, Centro de Investigacion Cafesalud Medicina Prepagada, Cra 14 No Piso Sexto, Bogota, Colombia

103, De La Salle Health Sciences Institute, DBB B Dasmarinas, Cavite 4114, Philippines

102, De La Salle Health Sciences Institute, Dbbb Dasmarinas, Cavite 4114, Philippines

318 Avail Clinical Research, 860 Peachwood Drive, Deland, Florida 32720, United States

306 Westside Center for Clinical Research, 810 Lane Avenue South, Jacksonville, Florida 32205, United States

328 Miami Research Associates, 6141 Sunset Drive, Miami, Florida 33143, United States

320 Johnson County Clin-Trials, 15602 College Blvd, Lenexa, Kansas 66219, United States

316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr, Newton, Kansas 67114, United States

310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600, Wichita, Kansas 67205, United States

322 Heartland Research Associates Wichita, 1709 S. Rock Road, Wichita, Kansas 67207, United States

105, Manila Doctors Hospital, 667 United Nations Avenue, Ermita, Manila 1000, Philippines

106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta., Mesa, Manila 1016, Philippines

104 Jose Reyes Memorial Medical Center, Rizal Avenue Avenida Cruz, Manila 1003, Philippines

107 Philippine General Hospital, Taft Avenue, Manila 1000, Philippines

314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827, Saint Louis, Missouri 63104, United States

330 Mercy Health Research, 12680 Olive Blvd Suite 200, Saint Louis, Missouri 63141, United States

101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest, Corporate City Alabang, Muntinlupa 1781, Philippines

109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST, Corporate City Alabang, Muntinlupa, Philippines

313 Clinical Research Center of Nevada, 7425 W Azure Suite 150, Las Vegas, Nevada 89130, United States

311 Regional Clinical Research INC, 415 Hooper Road, Endwell, New York 13760, United States

326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104, Raleigh, North Carolina 27612, United States

332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306, Winston-Salem, North Carolina 27103, United States

303 Prestige Clinical Research, 333 Conover Drive, Franklin, Ohio 45005, United States

325 Omega Medical Research, 400 Bald Hill Road, Warwick, Rhode Island 02886, United States

108, City Health Office 1 Rosa City, City Health Office 1, Rosa City 4026, Philippines

312 Spartanburg Regional Medical Center, 485 Simuel Road, Spartanburg, South Carolina 29303, United States

321 Jordan River Family Medicine, 1868 West 9800 South Ste 100, Jordan, Utah, United States

305 Foothill Family Clinic South, 6360 South 3000 East, Salt Lake City, Utah 84121, United States

317 J. Lewis Research Inc., 2295 Foothill Drive, Salt Lake City, Utah 84109, United States

323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500, Fairfax, Virginia 22030, United States

Additional Information

Starting date: August 2010
Last updated: June 16, 2014

Page last updated: August 20, 2015

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