Phase 2
N=124
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
SARS-CoV-2 Infection, COVID19
Bottom Line
View on ClinicalTrials.gov: NCT04895982 ↗Enrolled (actual)
124
Serious AEs
19.4%
Results posted
Oct 2024
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection — 600.2; 884.7 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BNT162b2 (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- BioNTech SE
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
600.2; 884.7 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
758.4; 741.2; 4592.3 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
7330.0; 43.5; 2368.1 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
596.5; 115.0 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
837.5; 9576.3 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
754.2; 5335.3; 5330.8 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
2845.0 | — |
| PRIMARY GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection |
1474.0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years |
11.1; 6.7; 0; 11.1; 6.7; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years |
10.5; 8.3; 9.1; 10.5; 4.2; 4.5 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years |
28.6; 0; 14.3; 28.6; 0; 14.3 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years |
0; 6.7; 0; 0; 6.7; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years |
10.5; 12.5; 22.7; 10.5; 4.2; 13.6 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years |
14.3; 0; 16.7; 14.3; 0; 16.7 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years |
11.1; 13.3; 0; 0; 6.7; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years |
29.4; 4.3; 14.3; 17.6; 0; 9.5 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years |
14.3; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years |
25.0; 0; 25.0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years |
28.6; 16.7; 0; 14.3; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years |
8.3; 5.3; 20.0; 8.3; 5.3; 6.7 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years |
75.0; 0; 66.7; 75.0; 0; 66.7 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years |
33.3; 0; 33.3; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years |
0; 0; 15.4; 0; 0; 7.7 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years |
0; 4.2; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years |
14.3; 0; 0; 14.3; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years |
11.1; 0; 0; 11.1; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years |
5.3; 0; 4.5; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years |
28.6; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years |
20.0; 0; 0; 20.0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years |
0; 6.7; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years |
17.6; 0; 19.0; 11.8; 0; 14.3 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years |
42.9; 0; 33.3; 28.6; 0; 33.3 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years |
28.6; 0; 0; 14.3; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years |
8.3; 5.3; 6.7; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years |
25.0; 0; 33.3; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years |
44.4; 33.3; 38.5 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years |
36.8; 8.3; 27.3 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years |
14.3; 0; 14.3 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years |
20.0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years |
33.3; 40.0; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years |
29.4; 8.7; 4.5 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years |
14.3; 0; 16.7 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years |
0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years |
14.3; 16.7; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years |
0; 36.8; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years |
0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years |
0; 100.0 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years |
0; 53.3; 23.1 | — |
| PRIMARY Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years |
15.8; 20.8; 13.6 | — |
| PRIMARY Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years |
0; 0; 0 | — |
| PRIMARY Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years |
20.0; 0; 100.0 | — |
Summary
This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. 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 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.
Eligibility Criteria
Inclusion Criteria
- Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1).
- 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.
- Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1).
- Participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period.
- 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.
- Participants who are immunocompromised by virtue of the following:
- Having known non-small cell lung cancer (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 (programmed cell death protein 1 (PD-1)/ programmed death-ligand 1 (PD-L1) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
- Receiving targeted drug therapy treatment (epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene tyrosine-protein kinase (ROS1), v-raf murine sarcoma viral oncogene homolog B1 (BRAF),rearranged during transfection (RET),hepatocyte growth factor receptor (MET), neurotrophic tyrosine kinase (NTRK) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
- Having known chronic lymphocytic leukemia (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 Bruton tyrosine kinase (BTK) inhibitor, phosphoinositide 3-kinase (PI3K) inhibitor, or B-cell lymphoma-2 (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, tumor necrosis factor alpha (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
- The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The invest
Data sourced from ClinicalTrials.gov (NCT04895982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.