Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
- Conditions
- Pneumococcal DiseaseSARS-CoV-2 InfectionCOVID-19
- Interventions
- Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)Biological: BNT162b2Other: Saline
- Registration Number
- NCT04887948
- Lead Sponsor
- Pfizer
- Brief Summary
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
- Male or female participants โฅ65 years of age at the time of consent
- Participating or participated in Study C4591001, received 2 doses of 30 ยตg BNT162b2 with the second dose given โฅ6 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 โฅ12 months prior to the first vaccination in this study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coadministration Group BNT162b2 Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit. 20vPnC-only Group 20-valent pneumococcal conjugate vaccine (20vPnC) Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit. BNT162b2-only Group BNT162b2 Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit. BNT162b2-only Group Saline Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit. Coadministration Group 20-valent pneumococcal conjugate vaccine (20vPnC) Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit. 20vPnC-only Group Saline Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination From day of vaccination (Day 1) up to 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.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 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.
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination 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.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination From day of vaccination (Day 1) up to 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.
- Secondary Outcome Measures
Name Time Method Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2 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.
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC 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.
Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2 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.
Trial Locations
- Locations (24)
Aventiv Research Inc
๐บ๐ธColumbus, Ohio, United States
Acevedo Clinical Research Associates
๐บ๐ธMiami, Florida, United States
Anaheim Clinical Trials, LLC
๐บ๐ธAnaheim, California, United States
Diablo Clinical Research, Inc.
๐บ๐ธWalnut Creek, California, United States
Alliance for Multispecialty Research, LLC
๐บ๐ธKnoxville, Tennessee, United States
Research Centers of America ( Hollywood )
๐บ๐ธHollywood, Florida, United States
Clinical Research Atlanta
๐บ๐ธStockbridge, Georgia, United States
Solaris Clinical Research
๐บ๐ธMeridian, Idaho, United States
Meridian Clinical Research, LLC
๐บ๐ธEndwell, New York, United States
Clinical Research Professionals
๐บ๐ธChesterfield, Missouri, United States
Sundance Clinical Research
๐บ๐ธSaint Louis, Missouri, United States
Accellacare - Wilmington
๐บ๐ธWilmington, North Carolina, United States
DM Clinical Research
๐บ๐ธTomball, Texas, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
๐บ๐ธMemphis, Tennessee, United States
Martin Diagnostic Clinic
๐บ๐ธTomball, Texas, United States
Wenatchee Valley Hospital
๐บ๐ธWenatchee, Washington, United States
Indago Research & Health Center, Inc
๐บ๐ธHialeah, Florida, United States
Martins Diagnostic Clinic
๐บ๐ธTomball, Texas, United States
Clinical Neuroscience Solutions
๐บ๐ธOrlando, Florida, United States
Benchmark Research
๐บ๐ธAustin, Texas, United States
IMA Clinical Research San Antonio
๐บ๐ธSan Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
๐บ๐ธSalt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
๐บ๐ธSalt Lake City, Utah, United States
East-West Medical Research Institute
๐บ๐ธHonolulu, Hawaii, United States