Clinical trial NCT05310084: Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2022-04-04
Enrollment: 1134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1).

* Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group
* The duration of the study for each participant will be approximately 2 months
* There are 3 scheduled study visits each about 1 month apart
* The study will be conducted in New Zealand and Australia.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
timeFrame: Within 7 Days After Vaccination 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
timeFrame: Within 7 Days After Vaccination 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
timeFrame: Within 7 Days After Vaccination 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
timeFrame: Within 7 Days After Vaccination 2
measure: Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
timeFrame: Within 1 month after Vaccination 1
measure: Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
timeFrame: Within 1 month after Vaccination 2
measure: Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
timeFrame: Within 1 Month After Vaccination 1
measure: Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
timeFrame: Within 1 Month After Vaccination 2
measure: Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination
timeFrame: 1 Month After BNT162b2 vaccination
measure: Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination
timeFrame: 1 Month After SIIV vaccination
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination
timeFrame: Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination
measure: Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination
timeFrame: From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination
measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
timeFrame: Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination
measure: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
timeFrame: From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination
measure: Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
timeFrame: Before SIIV vaccination, and 1 month after SIIV vaccination
measure: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination
timeFrame: From before vaccination to 1 month after SIIV vaccination
Other outcomes:
Locations:
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Sydney
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Albion
country: Australia
facility: Paratus Clinical Research Brisbane
state: Queensland
city: Wellers Hill
country: Australia
facility: AusTrials - Wellers Hill
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Grafton
country: New Zealand
facility: New Zealand Clinical Research (Auckland)
state: Auckland
city: Grafton
country: New Zealand
facility: Optimal Clinical Trials
state: Auckland
city: New Lynn
country: New Zealand
facility: Southern Clinical Trials Totara
state: Auckland
city: Papamoa Beach
country: New Zealand
facility: Lakeland Clinical Trials Culloden
state: BAY OF Plenty
city: Rotorua
country: New Zealand
facility: Pacific Clinical Research Network - Rotorua
state: BAY OF Plenty
city: Tauranga
country: New Zealand
facility: P3 Research - Tauranga
state: BAY OF Plenty
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research (Christchurch)
state: Canterbury
city: Christchurch
country: New Zealand
facility: Pacific Clinical Research Network - Forte
state: Canterbury
city: Havelock North
country: New Zealand
facility: P3 Research - Hawke's Bay
state: Hawke's BAY
city: Palmerston North
country: New Zealand
facility: P3 Research - Palmerston North
state: Manawatu-wanganui
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials Waikato
state: Waikato
city: Ebdentown. Upper Hutt
country: New Zealand
facility: Lakeland Clinical Trials Wellington
state: Wellington
city: Paraparaumu
country: New Zealand
facility: P3 Research - Kapiti
state: Wellington
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Waitemata Ltd
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials
city: Nelson
country: New Zealand
facility: Southern Clinical Trials Tasman
city: Wellington
country: New Zealand
facility: Capital, Coast and Hutt Valley District - Wellington Regional Hospital
city: Wellington
country: New Zealand
facility: P3 Research - Wellington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: