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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Biological: BNT162b2; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1134
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Brookvale, New South Wales, Australia, 2100
      • Northern Beaches Clinical Research
    • Sydney, New South Wales, Australia, NSW 2035
      • Australian Clinical Research Network
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Albion, Queensland, Australia, 4010
      • Paratus Clinical Research Brisbane
    • Wellers Hill, Queensland, Australia, 4121
      • AusTrials - Wellers Hill
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
• New Zealand
  • Auckland, New Zealand, 2025
    • Middlemore Clinical Trials
  • Auckland, New Zealand, 0626
    • Southern Clinical Trials Waitemata Ltd
  • Auckland, New Zealand, 2025
    • Aotearoa Clinical Trials
  • Nelson, New Zealand, 7011
    • Southern Clinical Trials Tasman
  • Wellington, New Zealand, 6021
    • P3 Research - Wellington
  • Wellington, New Zealand, 6021
    • Capital, Coast and Hutt Valley District - Wellington Regional Hospital
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Optimal Clinical Trials
    • Grafton, Auckland, New Zealand, 1010
      • New Zealand Clinical Research (Auckland)
    • New Lynn, Auckland, New Zealand, 0600
      • Southern Clinical Trials Totara
  • BAY OF Plenty
    • Papamoa Beach, BAY OF Plenty, New Zealand, 3118
      • Lakeland Clinical Trials Culloden
    • Rotorua, BAY OF Plenty, New Zealand, 3010
      • Pacific Clinical Research Network - Rotorua
    • Tauranga, BAY OF Plenty, New Zealand, 3110
      • P3 Research - Tauranga
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • New Zealand Clinical Research (ChristChurch)
    • Christchurch, Canterbury, New Zealand, 8013
      • Pacific Clinical Research Network - Forte
  • Hawke's BAY
    • Havelock North, Hawke's BAY, New Zealand, 4130
      • P3 Research - Hawke's Bay
  • Manawatu-wanganui
    • Palmerston North, Manawatu-wanganui, New Zealand, 4414
      • P3 Research - Palmerston North
  • Waikato
    • Hamilton, Waikato, New Zealand, 3200
      • Lakeland Clinical Trials Waikato
  • Wellington
    • Ebdentown. Upper Hutt, Wellington, New Zealand, 5018
      • Lakeland Clinical Trials Wellington
    • Paraparaumu, Wellington, New Zealand, 5032
      • P3 Research - Kapiti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coadministration Group; BNT162b2 and SIIV followed by placebo a month later	Biological: BNT162b2; Intramuscular injection; Other: Placebo; Saline intramuscular injection; Biological: Seasonal Inactivated Influenza Vaccine; SIIV intramuscular injection
Experimental: Separate Administration Group; Placebo and SIIV followed by BNT162b2 a month later	Biological: BNT162b2; Intramuscular injection; Other: Placebo; Saline intramuscular injection; Biological: Seasonal Inactivated Influenza Vaccine; SIIV intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Adverse Events	The percentage of participants reporting AEs within 1 month after each vaccination	1 month after each vaccination
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Vaccine; Coronavirus; COVID-19; RNA Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: C4591030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes