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

NCT04895982

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COVID19 SARS-CoV-2 Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

COVID19 SARS-CoV-2 InfectionStudy to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
NCT04895982
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ?2 Years
Official Title  ICMJE A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ?2 YEARS OF AGE
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2 Infection, COVID19
Intervention  ICMJE Biological: BNT162b2
Intramuscular Injection
Study Arms  ICMJE Experimental: BNT162b2
Intramuscular Injection
Intervention: Biological: BNT162b2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2021)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 11, 2023
Estimated Primary Completion Date February 11, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, TNF? 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04895982
Other Study ID Numbers  ICMJE C4591024
2021-001290-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party BioNTech SE
Study Sponsor  ICMJE BioNTech SE
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account BioNTech SE
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP