Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 20vPnCBiological: 13vPnCOther: SalineBiological: PPSV23
- Registration Number
- NCT03760146
- Lead Sponsor
- Pfizer
- Brief Summary
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3902
- Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
- Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
- Pregnant female subjects or breastfeeding female subjects.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60 years and above 20vPnC/Saline 20vPnC 20vPnC and saline 60 years and above 20vPnC/Saline Saline 20vPnC and saline 60 years and above 13vPnC/PPSV23 13vPnC 13vPnC and PPSV23 50 through 59 years of age 20vPnC 20vPnC 20vPnC 18 through 49 years of age 20vPnC 20vPnC 20vPnC 18 through 49 years of age 13vPnC 13vPnC 13vPnC 60 years and above 13vPnC/PPSV23 PPSV23 13vPnC and PPSV23 50 through 59 years of age 13vPnC 13vPnC 13vPnC
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts Within 1 month after 20vPnC or 13vPnC An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts Within 10 days after 20vPnC or 13vPnC Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were 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 activity), moderate (interfered with activity), and severe (prevented daily activity).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts Within 7 days after 20vPnC or 13vPnC Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=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, 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 Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts Within 6 months after 20vPnC or 13vPnC An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts Within 6 months after 20vPnC or 13vPnC An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population 1 month after Vaccination 1 OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23" OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
- Secondary Outcome Measures
Name Time Method Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population 1 month after vaccination OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population 1 month after vaccination OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.
Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population Before Vaccination 1 to 1 month after Vaccination 1 OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population Before vaccination to 1 month after vaccination OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population Before vaccination to 1 month after vaccination Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23" The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23" OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population Before Vaccination 1 to 1 month after Vaccination 1 Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23" Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population 1 month after Vaccination 1 The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population 1 month after vaccination The percentage of participants with OPA titers \>=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only.
Trial Locations
- Locations (59)
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Kaiser Permanente Washington Health Research Institute
🇺🇸Seattle, Washington, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
East Valley Gastroenterology and Hepatology Associates
🇺🇸Chandler, Arizona, United States
ActivMed Practices & Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
Clinical Research Consulting, LLC
🇺🇸Milford, Connecticut, United States
Accel Research Sites - Clinical Research Unit
🇺🇸DeLand, Florida, United States
Axtell Clinic, P.A.
🇺🇸Newton, Kansas, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Meridian Clinical Research, LLC
🇺🇸Dakota Dunes, South Dakota, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Research Centers of America, LLC
🇺🇸Hollywood, Florida, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Qps-Mra, Llc
🇺🇸South Miami, Florida, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
ProbarE i Lund
🇸🇪Lund, Sweden
Akardo Med Site
🇸🇪Stockholm, Sweden
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
HealthFirst Medical Group
🇺🇸Fort Worth, Texas, United States
Ladulaas Kliniska Studier
🇸🇪Boras, Sweden
J. Lewis Research Inc. / Foothill Family Clinic Draper
🇺🇸Draper, Utah, United States
Avdelningen för kliniska prövningar
🇸🇪Örebro, Sweden
Infektionskliniken Malarsjukhuset
🇸🇪Eskilstuna, Sweden
J. Lewis Research, Inc. - Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Bellaire Doctor's Clinic
🇺🇸Bellaire, Texas, United States
Ventavia Research Group, LLC
🇺🇸Spring, Texas, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Karolinska Trial Alliance, KTA Prim
🇸🇪Stockholm, Sweden
Accel Research Sites
🇺🇸Birmingham, Alabama, United States
The Pain Center of Arizona
🇺🇸Phoenix, Arizona, United States
MedPharmics, LLC
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Meridian Clinical Research LLC
🇺🇸Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center (CCHMC)
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, 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
Northwest Family Physicians
🇺🇸Wichita, Kansas, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States