Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

839

Participants

Timeline

Start Date

April 13, 2021

Primary Completion Date

September 22, 2021

Study Completion Date

March 3, 2022

Conditions
Influenza
Interventions
DRUG

aQII-1

Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

DRUG

aQII-3 Investigational

Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

DRUG

aQII-6 Investigational

Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

OTHER

aQII-7 Investigational

Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

DRUG

aQII-9 Investigational

Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

DRUG

aQII-10 Investigational

Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

DRUG

aQII-11 Investigational

Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

DRUG

Licensed QII Active Comparator

Biological/Vaccine: Licensed QII Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.

Trial Locations (30)

1000

60805 - Manila Doctors' Hospital, Ermita

60803 - Philippine General Hospital, Manila

1010

55406 - Optimal Clinical Trials, Auckland

1050

71006 - Mzansi Ethical Research Centre (MERC), Mpumalanga

1109

60804 - Quirino Memorial Medical Center, Quezon City

2013

71001 - Wits Clinical Researc - Chris Hani Baragwanath Academic Hospital, Soweto

2019

3610- Emeritis Research, Botany

2035

03608 - Australian Clinical Research Network - ACRN [NSW], Maroubra

2100

3609 - Northern Beaches Clinical Research [NSW], Brookvale

2113

71003- Newtown Clinical Research, Newtown

2148

03605 - PCRN_Paratus Clinical Research (Central Coast), Blacktown

2259

03602 - PCRN_Paratus Clinical Research,(Western Sydney) [NSW], Kanwal

2617

03607 - PCRN_Paratus Clinical Research, Bruce

3000

3611 - The University of Melbourne Peter Doherty Institute for Infection and Immunity, Melbourne

3010

55405 - PCRN_Lakeland Clinical Trials, Rotorua

3200

55403-PCRN_Lakeland Clinical Trials Waikato, Hamilton

4068

03601 - AusTrials Taringa [QLD], Taringa

4114

60801 - De La Salle Medical and Health Sciences Institute, Dasmariñas

4121

03606 - AusTrials Tarragindi (Aus Trial Wellers Hill)[QLD], Tarragindi

4506

03604 - University of the Sunshine Coast Clinical Trials Centre, Morayfield

4556

03603 - University of the Sunshine Coast, Sippy Downs

5000

60802 - West Visayas University Medical Center, Jaro

7505

71004 - Tread Research -- Tygerberg Hospital, Cape Town

7531

71005 South Africa Haylene71005 - Tiervlei Trial Centre -- Karl Bremer Hospital, Bellville

7626

71009 - Be Part Yoluntu Centre, Paarl

8013

55404- PCRN_Southern Clinical Trials Christchurch, Christchurch

9301

71002 - JOSHA Research, Bloemfontein

71011 - Farmovs, Bloemfontein

0626

55402- PCRN_Southern Clinical Trials Waitemata, Birkenhead

0600

55401- PCRN_Southern Clinical Trials Totara, New Lynn

All Listed Sponsors
lead

Seqirus

INDUSTRY