Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age

NCT ID: NCT05310084

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-10-05

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.

Conditions

SARS-CoV-2 Infection; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Coadministration Group

BNT162b2 and SIIV followed by placebo a month later

Group Type: EXPERIMENTAL

BNT162b2

Intervention Type: BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type: OTHER

Saline intramuscular injection

Seasonal Inactivated Influenza Vaccine

Intervention Type: BIOLOGICAL

SIIV intramuscular injection

Separate Administration Group

Placebo and SIIV followed by BNT162b2 a month later

Group Type: EXPERIMENTAL

BNT162b2

Intervention Type: BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type: OTHER

Saline intramuscular injection

Seasonal Inactivated Influenza Vaccine

Intervention Type: BIOLOGICAL

SIIV intramuscular injection

Interventions

BNT162b2

Intramuscular injection

Intervention Type: BIOLOGICAL

Placebo

Saline intramuscular injection

Intervention Type: OTHER

Seasonal Inactivated Influenza Vaccine

SIIV intramuscular injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

BioNTech SE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

Australian Clinical Research Network

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Paratus Clinical Research Brisbane

Albion, Queensland, Australia

AusTrials - Wellers Hill

Wellers Hill, Queensland, Australia

Emeritus Research

Camberwell, Victoria, Australia

Barwon Health

Geelong, Victoria, Australia

New Zealand Clinical Research (Auckland)

Grafton, Auckland, New Zealand

Optimal Clinical Trials

Grafton, Auckland, New Zealand

Southern Clinical Trials Totara

New Lynn, Auckland, New Zealand

Lakeland Clinical Trials Culloden

Papamoa Beach, Bay of Plenty, New Zealand

Pacific Clinical Research Network - Rotorua

Rotorua, Bay of Plenty, New Zealand

P3 Research - Tauranga

Tauranga, Bay of Plenty, New Zealand

New Zealand Clinical Research (Christchurch)

Christchurch, Canterbury, New Zealand

Pacific Clinical Research Network - Forte

Christchurch, Canterbury, New Zealand

P3 Research - Hawke's Bay

Havelock North, Hawke's Bay Region, New Zealand

P3 Research - Palmerston North

Palmerston North, Manawatu-Wanganui, New Zealand

Lakeland Clinical Trials Waikato

Hamilton, Waikato Region, New Zealand

Lakeland Clinical Trials Wellington

Ebdentown. Upper Hutt, Wellington Region, New Zealand

P3 Research - Kapiti

Paraparaumu, Wellington Region, New Zealand

Southern Clinical Trials Waitemata Ltd

Auckland, , New Zealand

Aotearoa Clinical Trials

Auckland, , New Zealand

Middlemore Clinical Trials

Auckland, , New Zealand

Southern Clinical Trials Tasman

Nelson, , New Zealand

Capital, Coast and Hutt Valley District - Wellington Regional Hospital

Wellington, , New Zealand

P3 Research - Wellington

Wellington, , New Zealand

Countries

Australia; New Zealand

References

Murdoch L, Quan K, Baber JA, Ho AWY, Zhang Y, Xu X, Lu C, Cooper D, Koury K, Lockhart SP, Anderson AS, Tureci O, Sahin U, Swanson KA, Gruber WC, Kitchin N; C4591030 Clinical Trial Group. Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults. Infect Dis Ther. 2023 Sep;12(9):2241-2258. doi: 10.1007/s40121-023-00863-5. Epub 2023 Sep 12.

Reference Type: DERIVED

PMID: 37698774 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4591030

To obtain contact information for a study center near you, click here.

Other Identifiers

C4591030

Identifier Type: -

Identifier Source: org_study_id

NCT06137001

Identifier Type: -

Identifier Source: nct_alias