Phase 3
Completed N=7,104
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Source: ClinicalTrials.gov NCT01162122 ↗Enrolled (actual)
7,104
Serious AEs
7.2%
Results posted
Jun 2014
Primary outcomePrimary: Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV — 209; 187; 199; 548 Titers
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV |
209; 187; 199; 548; 542; 556 | — |
| PRIMARY Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS |
198; 141; 544; 337; 55; 48 | — |
| PRIMARY Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS |
77.4; 67.6; 74.0; 60.7; 47.0; 41.2 | — |
| PRIMARY Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS) |
196; 142; 534; 334; 54; 48 | — |
| PRIMARY Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS |
77.3; 67.8; 73.7; 60.6; 46.9; 41.5 | — |
| PRIMARY Percentage of Subjects With HI Titers ≥40 Against Homologous Strains |
91.1; 84.5; 99.0; 97.0; 64.6; 58.9 | — |
| PRIMARY Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains |
77.3; 67.8; 73.7; 60.6; 46.9; 41.5 | — |
| PRIMARY Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains |
13; 9.77; 10; 6.54; 4.85; 4.27 | — |
| PRIMARY Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains |
95.8; 94.0; 99.6; 98.4; 76.2; 72.4 | — |
| PRIMARY Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains |
5.76; 3.87; 4.95; 3.54; 5.76; 5.28 | — |
| PRIMARY Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains |
60.4; 48.4; 57.5; 45.5; 53.3; 49.8 | — |
| SECONDARY Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS |
221; 161; 519; 331; 61; 54 | — |
| SECONDARY 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 |
73.6; 61.7; 69.1; 54.8; 40.0; 34.0 | — |
| SECONDARY Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS |
212; 160; 499; 324; 60; 54 | — |
| SECONDARY 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 |
72.6; 62.0; 68.9; 55.2; 40.0; 34.3 | — |
| SECONDARY Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS |
369; 255; 1037; 764; 89; 82 | — |
| SECONDARY Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS |
362; 243; 1016; 738; 87; 80 | — |
| SECONDARY Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS |
60.0; 49.1; 57.0; 45.9; 52.8; 49.3 | — |
| SECONDARY Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS |
60.4; 48.4; 57.5; 45.5; 53.3; 49.8 | — |
| SECONDARY Persistence of GMTs Against Homologous and Heterologous Strains |
71; 68; 49; 52; 123; 91 | — |
| SECONDARY Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains |
28.6; 26.2; 18.5; 19.4; 36.0; 24.6 | — |
| SECONDARY Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups |
119; 97; 20; 21; 102; 113 | — |
| SECONDARY Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups |
55; 48 | — |
| SECONDARY Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups |
275; 289 | — |
| SECONDARY All Cause Mortality Rate, Across Vaccine Groups |
7; 7; 0; 0; 39; 34 | — |
| SECONDARY Number of Subjects Reporting Solicited Adverse Events Following Vaccination |
1137; 593; 43; 18; 45; 17 | — |
Eligibility 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
- 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.
- Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
- Known or suspected impairment/alteration of immune function.
- Individuals with a known bleeding diathesis.
- History of Guillain-Barré syndrome.
- 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).
- 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.
- 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.
- Individuals who had received vaccination against seasonal influenza in the previous 6 months.
- Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Individuals providing consent who did not consent to the retention of their serum samples after study completion.
- 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.
- Subjects from whom blood could not be drawn at visit 1.
Data sourced from ClinicalTrials.gov (NCT01162122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.