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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137001
• Other study ID #: C4591030
• Status: Completed
• Phase: Phase 3
• Start date: April 20, 2022
• Est. completion date: October 5, 2022

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• BNT162b2
Intramuscular injection

Other:
• Placebo
Saline intramuscular injection

Biological:
• Seasonal Inactivated Influenza Vaccine
SIIV intramuscular injection

Locations

Country	Name	City	State
Australia	Paratus Clinical Research Brisbane	Albion	Queensland
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Australian Clinical Research Network	Sydney	New South Wales
Australia	AusTrials - Wellers Hill	Wellers Hill	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
New Zealand	Aotearoa Clinical Trials	Auckland
New Zealand	Middlemore Clinical Trials	Auckland
New Zealand	Southern Clinical Trials Waitemata Ltd	Auckland
New Zealand	New Zealand Clinical Research (Christchurch)	Christchurch	Canterbury
New Zealand	Pacific Clinical Research Network - Forte	Christchurch	Canterbury
New Zealand	Lakeland Clinical Trials Wellington	Ebdentown. Upper Hutt	Wellington
New Zealand	New Zealand Clinical Research (Auckland)	Grafton	Auckland
New Zealand	Optimal Clinical Trials	Grafton	Auckland
New Zealand	Lakeland Clinical Trials Waikato	Hamilton	Waikato
New Zealand	P3 Research - Hawke's Bay	Havelock North	Hawke's BAY
New Zealand	Southern Clinical Trials Tasman	Nelson
New Zealand	Southern Clinical Trials Totara	New Lynn	Auckland
New Zealand	P3 Research - Palmerston North	Palmerston North	Manawatu-wanganui
New Zealand	Lakeland Clinical Trials Culloden	Papamoa Beach	BAY OF Plenty
New Zealand	P3 Research - Kapiti	Paraparaumu	Wellington
New Zealand	Pacific Clinical Research Network - Rotorua	Rotorua	BAY OF Plenty
New Zealand	P3 Research - Tauranga	Tauranga	BAY OF Plenty
New Zealand	Capital, Coast and Hutt Valley District - Wellington Regional Hospital	Wellington
New Zealand	P3 Research - Wellington	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local reactions (redness, swelling, and pain at the injection site) self-reported on e-diaries	The percentage of participants reporting prompted local reactions within 7 days after each vaccination	7 days after each vaccination
Primary	Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) self-reported on e-diaries	The percentage of participants reporting prompted systemic events within 7 days after each vaccination	7 days after each vaccination
Primary	Adverse Events	The percentage of participants reporting AEs within 1 month after each vaccination	1 month after each vaccination
Primary	Serious Adverse Events	The percentage of participants reporting SAEs from the first vaccination up to 1 month after the last vaccination	1 month after the last vaccination
Primary	Full-length S-binding IgG levels	Geometric mean ratio of full-length S-binding IgG levels 1 month after vaccination with BNT162b2 in the coadministration group to the IgG levels 1 month after vaccination with BNT162b2 in the separate administration group	1 month after vaccination with BNT162b2
Primary	Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained)	Geometric mean ratio of the strain-specific HAI (or H3N2-neutralizing antibody) titers 1 month after vaccination with SIIV in the coadministration group to the corresponding HAI (or H3N2-neutralizing antibody) titers in the separate administration group	1 month after vaccination with SIIV
Secondary	Full-length S-binding IgG levels ; SARS-CoV-2 neutralizing titers (for a subset of approximately 200 participants) expressed as Geometric Mean Concentrations/Geometric Mean Titers	Geometric Mean Concentrations/Geometric Mean Titers elicited by BNT162b2 when coadministered with SIIV or administered alone	At baseline (before vaccination) and 1 month after vaccination with BNT162b2
Secondary	Full-length S-binding IgG levels ; SARS-CoV-2 neutralizing titers (for a subset of approximately 200 participants) expressed as Geometric Mean Fold Rise	Geometric Mean Fold Rise elicited by BNT162b2 when coadministered with SIIV or administered alone	At baseline (before vaccination) and 1 month after vaccination with BNT162b2
Secondary	Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained) expressed as Geometric Mean Titers	Geometric Mean Titers elicited by SIIV when coadministered with BNT162b2 or administered alone	At baseline (before vaccination) and 1 month after vaccination with SIIV
Secondary	Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained) expressed as Geometric Mean Fold Rise	Geometric Mean Fold Rise in strain-specific HAI titers elicited by SIIV when coadministered with BNT162b2 or administered alone	At baseline (before vaccination) and 1 month after vaccination with SIIV

External Links

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