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

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ClinicalTrials.gov Identifier: NCT05310084
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: BNT162b2 Other: Placebo Biological: Seasonal Inactivated Influenza Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is an Observer-Blind Study. The vaccines and placebo will be administered by an unblinded third-party site staff member.
Primary Purpose: Prevention
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
Actual Study Start Date : April 20, 2022
Estimated Primary Completion Date : September 21, 2022
Estimated Study Completion Date : September 21, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Local reactions (redness, swelling, and pain at the injection site) self-reported on e-diaries [ Time Frame: 7 days after each vaccination ]
    The percentage of participants reporting prompted local reactions within 7 days after each vaccination

  2. Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) self-reported on e-diaries [ Time Frame: 7 days after each vaccination ]
    The percentage of participants reporting prompted systemic events within 7 days after each vaccination

  3. Adverse Events [ Time Frame: 1 month after each vaccination ]
    The percentage of participants reporting AEs within 1 month after each vaccination

  4. Serious Adverse Events [ Time Frame: 1 month after the last vaccination ]
    The percentage of participants reporting SAEs from the first vaccination up to 1 month after the last vaccination

  5. Full-length S-binding IgG levels [ Time Frame: 1 month after vaccination with BNT162b2 ]
    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

  6. Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained) [ Time Frame: 1 month after vaccination with SIIV ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: At baseline (before vaccination) and 1 month after vaccination with BNT162b2 ]
    Geometric Mean Concentrations/Geometric Mean Titers elicited by BNT162b2 when coadministered with SIIV or administered alone

  2. Full-length S-binding IgG levels ; SARS-CoV-2 neutralizing titers (for a subset of approximately 200 participants) expressed as Geometric Mean Fold Rise [ Time Frame: At baseline (before vaccination) and 1 month after vaccination with BNT162b2 ]
    Geometric Mean Fold Rise elicited by BNT162b2 when coadministered with SIIV or administered alone

  3. Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained) expressed as Geometric Mean Titers [ Time Frame: At baseline (before vaccination) and 1 month after vaccination with SIIV ]
    Geometric Mean Titers elicited by SIIV when coadministered with BNT162b2 or administered alone

  4. Strain-specific HAI titers ; H3N2-neutralizing antibody titers (if H3N2-HAI titers cannot be obtained) expressed as Geometric Mean Fold Rise [ Time Frame: At baseline (before vaccination) and 1 month after vaccination with SIIV ]
    Geometric Mean Fold Rise in strain-specific HAI titers elicited by SIIV when coadministered with BNT162b2 or administered alone



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05310084


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT05310084    
Other Study ID Numbers: C4591030
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioNTech SE:
COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases