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Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

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ClinicalTrials.gov Identifier: NCT04895982
Recruitment Status : Not yet recruiting
First Posted : May 21, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Brief Summary:
This is a 3 dose study with 420 participants (240 adults, 180 children). Participants are going to be enrolled based on conditions that make them immunocompromised, Participants are going to be followed up for 6 months after dose 3, and each participant is projected to be on the study for 14 months, This study will be conducted in the United States, Brazil and Germany

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection, COVID19 Biological: BNT162b2 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
Estimated Study Start Date : October 30, 2021
Estimated Primary Completion Date : February 18, 2023
Estimated Study Completion Date : February 18, 2023

Arm Intervention/treatment
Experimental: BNT162b2
Intramuscular Injection
Biological: BNT162b2
Intramuscular Injection




Primary Outcome Measures :
  1. Percentage of participants reporting local reactions [ Time Frame: For 7 days after Dose 1, Dose 2 and Dose 3 ]
    Pain at the injection site, redness and swelling, as self reported in electronic diaries

  2. Percentage of participants reporting systemic events [ Time Frame: For 7 days after Dose 1, Dose 2 and Dose 3 ]
    Fever, Fatigue, Headache, Chills, Vomiting, Diarrhoea, New or Worsened Muscle Pain, New or Worsened Joint Pain, as self reported in electronic diaries

  3. Percentage of participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff

  4. Percentage of participants reporting serious adverse events [ Time Frame: From Dose 1 through 6 months after Dose 3 ]
    As elicited by investigational site staff

  5. GMTs of all participants, measured by SARS-CoV-2 neutralising titers, without serological or virological evidence of past SARS-CoV-2 infection and with an immunocompromised state, as specified in the protocol [ Time Frame: 1 month after Dose 2 ]
    As measured at the central laboratory

  6. Percentage of participants reporting adverse events [ Time Frame: From Dose 3 to 1 month after Dose 3 ]
    As elicited by investigational site staff



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1).

    2. Participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

    3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1).

    4. Participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period.

    5. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.

    6. Participants who are immunocompromised by virtue of the following:

    • Having known NSCLC and is ≥18 years of age with at least 1 of the following:
    • Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or
    • Receiving checkpoint inhibitor treatment (PD-1/PD-L1 inhibitor, CTLA-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
    • Receiving targeted drug therapy treatment (EGFR, ALK, ROS1, BRAF, RET, MET, NTRK inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
    • Having known CLL and is ≥18 years of age with at least 1 of the following:
    • Has asymptomatic disease (eg, Rai stage <3, Binet stage A or B) and is undergoing observation and does not receive any treatment for CLL; or
    • Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has received at least 3 cycles prior to enrollment; and/or
    • Receives a BTK inhibitor, PI3K inhibitor, or BCL-2 inhibitor OR
    • Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age OR
    • Is on active immunomodulator therapy (eg, TNFα inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and Crohn's disease) at a stable* dose

      • Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to Visit 1.

OR

  • Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 1), and is ≥2 to <18 years of age OR
  • Has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (Visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to <18 years of age 7. The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian (as defined in Appendix 1) before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Exclusion Criteria:

  • 1. Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19, or a past clinical diagnosis of MIS-C.

    2. Participants with active GVHD, transplant rejection, or PTLD, or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment (Visit 1).

    3. Participants <18 years of age whose weight is less than the 5th percentile of age-adjusted ideal body weight.

    4. 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.

    5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).

    6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

    7. Participant who is pregnant or breastfeeding. 8. Participants who may be ineligible because of the number of phlebotomy assessments during this study, in the opinion of the investigator.

    9. Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.

    10. Previous vaccination with any coronavirus vaccine. 11. Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to Dose 3.

    12. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.

    13. Previous participation in other studies involving study intervention containing LNPs.

    14. Participants who are direct descendants (child or grandchild, parent or grandparent) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

    15. Investigator site staff or Pfizer 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): NCT04895982


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: NCT04895982    
Other Study ID Numbers: C4591024
2021-001290-23 ( EudraCT Number )
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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:
COVID19
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