COVID-19 Clinical Trial
Official title:
A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER
Verified date | November 2022 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone
Status | Completed |
Enrollment | 570 |
Est. completion date | December 8, 2021 |
Est. primary completion date | December 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Male or female participants =65 years of age at the time of consent - Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given =6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2 - Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease - Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination =12 months prior to the first vaccination in this study Exclusion Criteria: - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) - Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study - Previous clinical or microbiological diagnosis of COVID-19 - Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation - Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Anaheim Clinical Trials, LLC | Anaheim | California |
United States | Benchmark Research | Austin | Texas |
United States | Clinical Research Professionals | Chesterfield | Missouri |
United States | Aventiv Research Inc | Columbus | Ohio |
United States | Alliance for Multispecialty Research, LLC | Coral Gables | Florida |
United States | Meridian Clinical Research, LLC | Endwell | New York |
United States | Indago Research & Health Center, Inc | Hialeah | Florida |
United States | Research Centers of America ( Hollywood ) | Hollywood | Florida |
United States | East-West Medical Research Institute | Honolulu | Hawaii |
United States | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee |
United States | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee |
United States | Solaris Clinical Research | Meridian | Idaho |
United States | Acevedo Clinical Research Associates | Miami | Florida |
United States | Alliance for Multispecialty Research, LLC | Newton | Kansas |
United States | Meridian Clinical Research, LLC | Omaha | Nebraska |
United States | Clinical Neuroscience Solutions | Orlando | Florida |
United States | Sundance Clinical Research | Saint Louis | Missouri |
United States | J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah |
United States | J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah |
United States | IMA Clinical Research San Antonio | San Antonio | Texas |
United States | Clinical Research Atlanta | Stockbridge | Georgia |
United States | DM Clinical Research | Tomball | Texas |
United States | Martin Diagnostic Clinic | Tomball | Texas |
United States | Martins Diagnostic Clinic | Tomball | Texas |
United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
United States | Wenatchee Valley Hospital | Wenatchee | Washington |
United States | Accellacare - Wilmington | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination | Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented. | Within 10 days after vaccination | |
Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Systemic events including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Within 7 days after vaccination | |
Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | From day of vaccination (Day 1) up to 1 month after vaccination | |
Primary | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | From day of vaccination (Day 1) up to 6 months after vaccination | |
Secondary | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC | OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol. | 1 month after vaccination with 20vPnC | |
Secondary | Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2 | IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol. | 1 month after vaccination with BNT162b2 | |
Secondary | Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2 | The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol. | Before vaccination to 1 month after vaccination with BNT162b2 |
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