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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05310084




Registration number
NCT05310084
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022

Titles & IDs
Public title
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
Scientific title
A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE
Secondary ID [1] 0 0
C4591030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection 0 0
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BNT162b2
Other interventions - Placebo
Treatment: Other - Seasonal Inactivated Influenza Vaccine

Experimental: Coadministration Group - BNT162b2 and SIIV followed by placebo a month later

Experimental: Separate Administration Group - Placebo and SIIV followed by BNT162b2 a month later


Treatment: Other: BNT162b2
Intramuscular injection

Other interventions: Placebo
Saline intramuscular injection

Treatment: Other: Seasonal Inactivated Influenza Vaccine
SIIV intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Timepoint [1] 0 0
Within 7 Days After Vaccination 1
Primary outcome [2] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Timepoint [2] 0 0
Within 7 Days After Vaccination 2
Primary outcome [3] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Timepoint [3] 0 0
Within 7 Days After Vaccination 1
Primary outcome [4] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Timepoint [4] 0 0
Within 7 Days After Vaccination 2
Primary outcome [5] 0 0
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
Timepoint [5] 0 0
Within 1 month after Vaccination 1
Primary outcome [6] 0 0
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
Timepoint [6] 0 0
Within 1 month after Vaccination 2
Primary outcome [7] 0 0
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
Timepoint [7] 0 0
Within 1 Month After Vaccination 1
Primary outcome [8] 0 0
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
Timepoint [8] 0 0
Within 1 Month After Vaccination 2
Primary outcome [9] 0 0
Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination
Timepoint [9] 0 0
1 Month After BNT162b2 vaccination
Primary outcome [10] 0 0
Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination
Timepoint [10] 0 0
1 Month After SIIV vaccination
Secondary outcome [1] 0 0
Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination
Timepoint [1] 0 0
Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination
Secondary outcome [2] 0 0
Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination
Timepoint [2] 0 0
From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination
Secondary outcome [3] 0 0
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
Timepoint [3] 0 0
Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination
Secondary outcome [4] 0 0
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
Timepoint [4] 0 0
From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination
Secondary outcome [5] 0 0
Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
Timepoint [5] 0 0
Before SIIV vaccination, and 1 month after SIIV vaccination
Secondary outcome [6] 0 0
Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination
Timepoint [6] 0 0
From before vaccination to 1 month after SIIV vaccination

Eligibility
Key inclusion criteria
1. Participants 18 through 64 years of age, inclusive, at the time of consent.
2. Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention.
4. Have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). Documented confirmation of prior BNT162b2 receipt must be obtained prior to randomization.
5. Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
2. Allergy to egg proteins (egg or egg products) or chicken proteins.
3. History of Guillain-Barré syndrome.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. A positive SARS-CoV-2 test result (either by NAAT or rapid antigen test) within 28 days of Visit 1 (Day 1).
6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
8. Women who are pregnant or breastfeeding.
9. Vaccination with any influenza vaccine <6 months before study intervention administration, or planned receipt of any licensed or investigational nonstudy influenza vaccine during study participation.
10. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent), eg, for COPD, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
12. Receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration or planned receipt throughout the study.
13. Prior receipt of any COVID-19 vaccine other than BNT162b2 or receipt of more than 3 prior doses of BNT162b2.
14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
15. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2022
Sample size
Target
Accrual to date
Final
1134
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 0 0
Australian Clinical Research Network - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Paratus Clinical Research Brisbane - Albion
Recruitment hospital [5] 0 0
AusTrials - Wellers Hill - Wellers Hill
Recruitment hospital [6] 0 0
Emeritus Research - Camberwell
Recruitment hospital [7] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
NSW 2035 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4010 - Albion
Recruitment postcode(s) [5] 0 0
4121 - Wellers Hill
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
BAY OF Plenty
Country [3] 0 0
New Zealand
State/province [3] 0 0
Canterbury
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hawke's BAY
Country [5] 0 0
New Zealand
State/province [5] 0 0
Manawatu-wanganui
Country [6] 0 0
New Zealand
State/province [6] 0 0
Waikato
Country [7] 0 0
New Zealand
State/province [7] 0 0
Wellington
Country [8] 0 0
New Zealand
State/province [8] 0 0
Nelson

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioNTech SE
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05310084