Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age

June 8, 2020 updated by: Seqirus

A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age

A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6790

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dimitrovgrad, Bulgaria
        • MHAT St. Ekaterina
      • Lom, Bulgaria
        • MHAT Sv Nikolay Chudotvoretz Lom
      • Plovdiv, Bulgaria
        • MBAL TRIMONCIUM (Synexus)
      • Ruse, Bulgaria, 7000
        • SHATPPD-Ruse
      • Silistra, Bulgaria
        • Mhat Silistra
      • Smolyan, Bulgaria
        • Mc Smolyan
      • Sofia, Bulgaria
        • Mc Avicena Sofia
      • Sofia, Bulgaria
        • Medical Center Excelsior
      • Sofia, Bulgaria
        • Medical Center Synexus Sofia EOOD
      • Sofia, Bulgaria
        • SHATPPD-Sofia, City
      • Stara Zagora, Bulgaria
        • Medical Centre Orpheus OOD (Synexus)
  • Colombia
      • Armenia, Colombia, NAP
        • Fundacion Cardiomet CEQUIN - Internal Medicine
      • Barranquilla, Colombia, NAP
        • Clinica de la Costa
      • Bogotá, Colombia, NAP
        • Centro de Atención e Investigación Médica S.A.S. - CAIMED S.A.S.
      • Bogotá, Colombia, NAP
        • Medplus Medicina Prepagada
      • Manizales, Colombia, 170004
        • Asociacion IPS Medicos Internistas de Caldas
    • Antioquia
      • Medellín, Antioquia, Colombia, 0500515
        • Hospital General de Medellín-Luz Castro de Gutiérrez - E.S.E
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 74136-3367
        • Caja de Compesanción Familiar CAFAM
  • Czechia
      • Brno, Czechia
        • CCBR Czech Brno, s.r.o.
      • Hradec Kralove, Czechia
        • FN Hradec Králové
      • Hradec Králové, Czechia
        • Centrum ockovani a cestovni mediciny
      • Ostrava, Czechia
        • CCBR Ostrava, s.r.o.
      • Pardubice, Czechia
        • CCBR Czech, a.s.
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia
        • Center for Clinical and Basic Research
      • Tallinn, Harjumaa, Estonia
        • Medicum AS
      • Tallinn, Harjumaa, Estonia
        • Merelahe Family Doctors Centre
    • Järvamaa
      • Paide, Järvamaa, Estonia
        • Vee Family Doctors Centre
    • Tartumaa
      • Tartu, Tartumaa, Estonia
        • Clinical Research Center
      • Tartu, Tartumaa, Estonia
        • Family Doctors Pullerits & Gavronski
  • Latvia
      • Balvi, Latvia
        • Practice Dr Liga Kozlovska
      • Kuldiga, Latvia
        • Practice Dr Ruta Eglite
      • Riga, Latvia
        • Family Doctor Andra Lasmane clinic "ALMA"
      • Tukums, Latvia
        • Practice Dr Inese Petrova
  • Lithuania
      • Kaunas, Lithuania
        • JSC Saules seimos medicinos centras
      • Kaunas, Lithuania
        • Kauno klinikine ligonine
      • Kaunas, Lithuania
        • Lietuvos sveikatos mokslų universitetas
      • Kaunas, Lithuania
        • UAB InMedica
      • Klaipeda, Lithuania
        • Klaipeda university hospital
      • Siauliai, Lithuania
        • Republican Siauliai Hospital
      • Vilnius, Lithuania
        • CCBR
  • Malaysia
      • Alor Setar, Malaysia
        • Hospital Sultanah Bahiyah
      • Batu Caves, Malaysia
        • Hospital Selayang
      • Ipoh, Malaysia
        • Klinik Kesihatan Greentown
      • Kota Bharu, Malaysia
        • Hospital Raja Perempuan Zainab II
      • Kuala Lumpur, Malaysia
        • University Malaya Medical Centre (UMMC)
      • Seremban, Malaysia
        • Klinik Kesihatan Seremban 2
      • Seri Manjung, Malaysia
        • Hospital Seri Manjung
      • Sibu, Malaysia
        • Hospital Sibu
  • Philippines
      • Bulacan, Philippines, 3019
        • Marilao St. Michael Family Hospital
      • Manila, Philippines, 1000
        • Philippine General Hospital
      • Pasay, Philippines, 1300
        • San Juan De Dios Hospital
    • Cavite
      • Dasmariñas, Cavite, Philippines, 4114
        • De La Salle Health Sciences Institute
    • Iloilo
      • Jaro, Iloilo, Philippines, 5000
        • West Visayas State University - Medical Center
    • National Capital Region
      • Quezon, National Capital Region, Philippines, 1109
        • Quirino Memorial Medical Center
  • Poland
      • Bydgoszcz, Poland
        • Centrum Medyczne Pratia Bydgoszcz
      • Lodz, Poland
        • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego sp. z o.o.
      • Nowy Duninow, Poland
        • RCMed Oddział Nowy Duninow
      • Sochaczew, Poland
        • RCMed Oddzial Sochaczew
      • Torun, Poland
        • Medical Trials Institute
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland
        • Synexus Polska Sp. z o.o.
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej VITAMED
    • Mazowieckie
      • Plock, Mazowieckie, Poland
        • NZOZ Centrum Medyczne "OMEGA" sp. z o.o.
      • Warszawa, Mazowieckie, Poland
        • Centrum Medyczne Pratia Warszawa
      • Warszawa, Mazowieckie, Poland
        • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-382
        • Synexus Polska Sp. z o.o.
      • Gdynia, Pomorskie, Poland
        • Centrum Medyczne Pratia Gdynia
    • Slaskie
      • Katowice, Slaskie, Poland
        • Centrum Medyczne Pratia Katowice
      • Katowice, Slaskie, Poland
        • Praktyka Lekarzy Rodzinnych SALUS
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland
        • Synexus Polska sp. z o.o
  • Romania
      • Arad, Romania
        • Cabinet dr. Dana OLAR
      • Brasov, Romania
        • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
      • Bucuresti, Romania
        • Cabinet Medical Individual Craciun-Nicodin Maria Marcela
      • Bucuresti, Romania
        • Centrul Medical Sana
      • Bucuresti, Romania
        • Clinica Medicala Synexus
      • Cluj, Romania
        • Spitalul Clinic C.F. Cluj-Napoca
      • Resca, Romania
        • Clintrial Medical Center
      • Timisoara, Romania
        • Fundatia Cardioprevent
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand
        • Mahidol University (MU) - Faculty of Tropical Medicine
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University - Srinagarind Hospital - Medicine
      • Mueang Nonthaburi, Thailand
        • Bamrasnaradura Infectious Diseases Institute (BIDI)
  • Turkey
      • Ankara, Turkey
        • Hacettepe University Medical Faculty
      • Ankara, Turkey
        • Ankara Training and Research Hospital
      • Antalya, Turkey
        • Akdeniz University Medical Faculty
      • Cerrahpaşa, Turkey
        • Istanbul University Cerrahpasa Medical Faculty
      • Erzurum, Turkey
        • Ataturk University Medical Faculty
      • Izmir, Turkey
        • Ege University Medical Faculty
      • Kocaeli, Turkey
        • Kocaeli University Research and Application Hospital
      • Sakarya, Turkey
        • Sakarya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females ≥ 65 years old who are healthy or have co-morbidities
  2. Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  3. Ability to attend all scheduled visits and to comply with study procedures

Exclusion Criteria:

  1. Hypersensitivity, including allergy to any component of vaccines foreseen in this study
  2. Abnormal function of the immune system.
  3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
  4. Additional eligibility criteria may be discussed by contacting the site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: aQIV
MF59-adjuvanted Quadrivalent Influenza Vaccine (aQIV)
Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
1 dose approximately 0.5 mL of aQIV
Placebo Comparator: Non-influenza Comparator Vaccine
Non-influenza comparator vaccine
Biological: Non-Influenza Comparator (Boostrix)
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The primary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the primary endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE)
Time Frame: Day 1 through Day 7
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited local and systemic AEs up to 7 days after vaccination.
Day 1 through Day 7
Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs)
Time Frame: Within 30 days after of first occurrence RT-PCR confirmed Influenza
Safety of vaccination was assessed in terms of percentage of subjects reporting medically attended AEs within 30 days after of first occurrence RT-PCR confirmed influenza.
Within 30 days after of first occurrence RT-PCR confirmed Influenza
Safety Endpoint: Percentages of Subjects With Any Unsolicited AE
Time Frame: Day 1 through Day 366
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Day 1 through Day 366
Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI)
Time Frame: Day 1 to Day 366
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs up to 366 days after vaccination.
Day 1 to Day 366

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of RT-PCR-confirmed influenza due to any strain of influenza regardless of antigenic match to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary efficacy endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition.
Time Frame: Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using protocol defined ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition.
Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
The secondary efficacy endpoint was the time of first-occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine from Day 21 through 180 days after vaccination or end of the influenza season, whichever is longer, using modified CDC ILI definition. Absolute vaccine efficacy is VE=1-HR, where HR is the hazard ratio of aQIV vs non-influenza comparator estimated by the Cox proportional hazards model for the secondary endpoint.
Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer
Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT)
Time Frame: Days 1 and 22
The log-transformed antibody titers (GMT) at Day 1 and Day 22 were evaluated using an analysis of covariance (ANCOVA) model including factors for site/country, pre-vaccination titer, age, and comorbidity.
Days 1 and 22
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer
Time Frame: Day 22/Day 1
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1).
Day 22/Day 1
Immunogenicity Endpoint: Percentages of Subjects With an HI Titer ≥1:40
Time Frame: Day 22
The percentage of subjects vaccinated with aQIV with a HI antibody titers ≥1:40 was assessed for each of the 4 strains Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for percent of subjects with HI antibody titer ≥1:40 met or exceeded 60% at Day 22.
Day 22
Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR)
Time Frame: Day 22
The percentage of subjects achieving SCR at Day 22 was assessed for each of the 4 strains. SCR is defined as HI titer ≥1:40 for subjects seronegative at baseline (HI titer <1:10) or a minimum 4-fold increase in HI titer for subjects seropositive at baseline (HI titer ≥1:10) on Day 22. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody SCR met or exceeded 30% at Day 22.
Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seqirus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Program Manager, Seqirus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V118_18
  • 2015-000728-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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