RENOIR: Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
Study Details
Study Description
Brief Summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of RSVpreF in the prevention of LRTI-RSV in adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the safety, immunogenicity, and efficacy of RSVpreF or placebo (1:1 randomization) in adults. This will be a global study that will span multiple RSV seasons.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RSVpreF vaccine RSVpreF |
Biological: RSVpreF
RSV vaccine (RSVpreF)
|
| Placebo Comparator: Placebo dose Placebo |
Biological: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season [From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
- Proportion of participants reporting prompted local reactions within 7-days after vaccination [Within 7 days after vaccination]
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity
- Proportion of participants reporting prompted systemic events within 7-days after vaccination [Within 7 days after vaccination]
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, 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. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
- Proportion of participants reporting AE within 1-month after vaccination [Within 1 month after vaccination (up to 35 days)]
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
- Proportion of participants reporting SAE throughout the study [Throughout the study duration (an average of 30 months)]
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Proportion of participants reporting NDCMC throughout the study [Throughout the study duration (an average of 30 months)]
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
Secondary Outcome Measures
- Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season [From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
- Number of first episode of LRTI-RSV in the second RSV season [During the second RSV season (an average of 6 months)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
- Number of first episode of LRTI-RSV across 2 RSV seasons [From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
- Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season [From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
- Number of first episode of ARI-RSV in the second RSV season [During the second RSV season (an average of 6 months)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
- Number of first episode of ARI-RSV across 2 RSV seasons [From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
- Number of first episode of sLRTI-RSV in the second RSV season [During the second RSV season (an average of 6 months)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
- Number of first episode of sLRTI-RSV across 2 RSV seasons [From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)]
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
- Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers [Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination)]
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
-
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
-
Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
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Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
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Male or female participants ≥60 years of age.
-
Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
-
Female participants must not be of childbearing potential.
Exclusion Criteria:
-
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
-
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
-
Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
-
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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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.
-
Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3).
Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study
- Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
-
Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
-
Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Vincent's Birmingham (Pharmacy) | Birmingham | Alabama | United States | 35205 |
| 2 | St. Vincent's Birmingham | Birmingham | Alabama | United States | 35205 |
| 3 | Medical Affiliated Research Center | Huntsville | Alabama | United States | 35801 |
| 4 | Lenzmeier Family Medicine/CCT Research | Glendale | Arizona | United States | 85308 |
| 5 | Phoenix Clinical LLC | Phoenix | Arizona | United States | 85014 |
| 6 | HOPE Research Institute | Phoenix | Arizona | United States | 85018 |
| 7 | The Pain Center of Arizona | Phoenix | Arizona | United States | 85018 |
| 8 | HOPE Research Institute | Phoenix | Arizona | United States | 85023 |
| 9 | Cognitive Clinical Trials, LLC | Phoenix | Arizona | United States | 85044 |
| 10 | Headlands Research - Scottsdale | Scottsdale | Arizona | United States | 85260 |
| 11 | Alliance for Multispecialty Research, LLC | Tempe | Arizona | United States | 85281 |
| 12 | HOPE Research Institute - Tempe | Tempe | Arizona | United States | 85284 |
| 13 | Noble Clinical Research | Tucson | Arizona | United States | 85704 |
| 14 | The Institute for Liver Health dba Arizona Clinical Trials | Tucson | Arizona | United States | 85712 |
| 15 | Hope Clinical Research | Canoga Park | California | United States | 91303 |
| 16 | eStudySite | Chula Vista | California | United States | 91911 |
| 17 | Benchmark Research | Colton | California | United States | 92324 |
| 18 | West Coast Research | Dublin | California | United States | 94568 |
| 19 | Marvel Clinical Research 002, LLC | Huntington Beach | California | United States | 92647 |
| 20 | Chemidox Clinical Trials | Lancaster | California | United States | 93534 |
| 21 | Ark Clinical Research | Long Beach | California | United States | 90806 |
| 22 | Downtown L.A. Research Center, Inc. | Los Angeles | California | United States | 90017 |
| 23 | Velocity Clinical Research, North Hollywood | North Hollywood | California | United States | 91606 |
| 24 | Fomat Medical Research | Oxnard | California | United States | 93030 |
| 25 | De Silva Medical Inc | Palmdale | California | United States | 93551 |
| 26 | Empire Clinical Research | Pomona | California | United States | 91767 |
| 27 | Paradigm Clinical Research Center | Redding | California | United States | 96001 |
| 28 | Artemis Institute for Clinical Research | Riverside | California | United States | 92503 |
| 29 | Benchmark Research | Sacramento | California | United States | 95864 |
| 30 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
| 31 | California Research Foundation | San Diego | California | United States | 92123 |
| 32 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 33 | Lynn Institute of Denver | Aurora | Colorado | United States | 80012 |
| 34 | Tekton Research, Inc. | Longmont | Colorado | United States | 80501 |
| 35 | Clinical Research Consulting | Milford | Connecticut | United States | 06460 |
| 36 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 37 | JEM Research Institute | Atlantis | Florida | United States | 33462 |
| 38 | Innovative Research of West Florida | Clearwater | Florida | United States | 33756 |
| 39 | Nature Coast Clinical Research | Crystal River | Florida | United States | 34429 |
| 40 | Universal Axon Clinical Research, LLC (Administrative) | Doral | Florida | United States | 33166 |
| 41 | Indago Research & Health Center, Inc | Hialeah | Florida | United States | 33012 |
| 42 | Doral Medical Research, LLC | Hialeah | Florida | United States | 33016 |
| 43 | Wr-Msra.Llc | Lake City | Florida | United States | 32055 |
| 44 | Global Health Research Center, Inc. | Miami Lakes | Florida | United States | 33016 |
| 45 | Optimus U Corporation | Miami | Florida | United States | 33125 |
| 46 | Advance Medical Research Center | Miami | Florida | United States | 33135 |
| 47 | Optimus U Corporation | Miami | Florida | United States | 33135 |
| 48 | Next Phase Research Alliance | Miami | Florida | United States | 33144 |
| 49 | New Horizon Research Center | Miami | Florida | United States | 33165 |
| 50 | De La Cruz Research, LLC | Miami | Florida | United States | 33184 |
| 51 | Clinical Site Partners, Inc dba CSP Miami | Miami | Florida | United States | 33186 |
| 52 | Headlands Research Orlando | Orlando | Florida | United States | 32819 |
| 53 | Pines Care Research Center, LLC | Pembroke Pines | Florida | United States | 33024 |
| 54 | IDEAL Clinical Research | Pembroke Pines | Florida | United States | 33026 |
| 55 | DBC Research USA | Pembroke Pines | Florida | United States | 33029 |
| 56 | Invictus Clinical Research Group, LLC | Pompano Beach | Florida | United States | 33064 |
| 57 | Headlands Research Sarasota | Sarasota | Florida | United States | 34243 |
| 58 | Precision Clinical Research | Sunrise | Florida | United States | 33351 |
| 59 | Clinical Site Partners, Inc | Winter Park | Florida | United States | 32789 |
| 60 | Conquest Research, LLC | Winter Park | Florida | United States | 32789 |
| 61 | Javara - Privia Medical Group Georgia - Albany | Albany | Georgia | United States | 31707 |
| 62 | Coastal Heritage Clinical Research | Hinesville | Georgia | United States | 31313 |
| 63 | Javara Inc. | Savannah | Georgia | United States | 31406 |
| 64 | Meridian Clinical Research, LLC | Savannah | Georgia | United States | 31406 |
| 65 | Privia Medical Group Georgia, LLC | Savannah | Georgia | United States | 31406 |
| 66 | Clinical Research Atlanta | Stockbridge | Georgia | United States | 30281 |
| 67 | Javara Inc. | Thomasville | Georgia | United States | 31792 |
| 68 | Privia Medical Group Georgia, LLC | Thomasville | Georgia | United States | 31792 |
| 69 | Snake River Research, PLLC | Idaho Falls | Idaho | United States | 83404 |
| 70 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 71 | Great Lakes Clinical Trials | Chicago | Illinois | United States | 60640 |
| 72 | Accellacare (Administrative Only) | Downers Grove | Illinois | United States | 60515 |
| 73 | Affinity Health Corp | Oak Brook | Illinois | United States | 60523 |
| 74 | DM Clinical Research | River Forest | Illinois | United States | 60305 |
| 75 | MOC Research | Mishawaka | Indiana | United States | 46544 |
| 76 | Velocity Clinical Research Valparaiso | Valparaiso | Indiana | United States | 46383 |
| 77 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
| 78 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 79 | Meridian Clinical Research, LLC | Sioux City | Iowa | United States | 51106 |
| 80 | Alliance for Multispecialty Research, LLC | Lexington | Kentucky | United States | 40509 |
| 81 | MedPharmics LLC | Metairie | Louisiana | United States | 70006 |
| 82 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 83 | Meridian Clinical Research, LLC | Rockville | Maryland | United States | 20854 |
| 84 | ActivMed Practices & Research, LLC | Beverly | Massachusetts | United States | 01915 |
| 85 | ActivMed Practices & Research, LLC | Methuen | Massachusetts | United States | 01844 |
| 86 | University of Massachusetts Chan Medical School | Worcester | Massachusetts | United States | 01655 |
| 87 | Michigan Center of Medical Research (MICHMER) | Farmington Hills | Michigan | United States | 48334 |
| 88 | Ascension St. John Hospital Vaccine Research Unit | Grosse Pointe Woods | Michigan | United States | 48236 |
| 89 | Van EIslander Cancer Center Pharmacy | Grosse Pointe Woods | Michigan | United States | 48236 |
| 90 | Oakland Medical Research | Troy | Michigan | United States | 48085 |
| 91 | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | United States | 48098 |
| 92 | Saint Louis University | Saint Louis | Missouri | United States | 63104 |
| 93 | Sundance Clinical Research | Saint Louis | Missouri | United States | 63141 |
| 94 | Skyline Medical Center, PC/CCT Research | Elkhorn | Nebraska | United States | 68022 |
| 95 | Quality Clinical Research | Omaha | Nebraska | United States | 68114 |
| 96 | Wr-Crcn, Llc. | Las Vegas | Nevada | United States | 89106 |
| 97 | Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | United States | 89119 |
| 98 | Las Vegas Clinical Trials | North Las Vegas | Nevada | United States | 89030 |
| 99 | ActivMed Practices and Research, LLC. | Portsmouth | New Hampshire | United States | 03801 |
| 100 | Amici Clinical Research LLC | Raritan | New Jersey | United States | 08869 |
| 101 | South Jersey Infectious Disease | Somers Point | New Jersey | United States | 08244 |
| 102 | Meridian Clinical Research, LLC | Binghamton | New York | United States | 13901 |
| 103 | CHEAR Center LLC | Bronx | New York | United States | 10455 |
| 104 | Meridian Clinical Research, LLC | Endwell | New York | United States | 13760 |
| 105 | Drug Trials America | Hartsdale | New York | United States | 10530 |
| 106 | Corning Center for Clinical Research | Horseheads | New York | United States | 14845 |
| 107 | Rochester Clinical Research, Inc. | Rochester | New York | United States | 14609 |
| 108 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 109 | Atrium Health - Strive Vaccine Research Clinic | Charlotte | North Carolina | United States | 28207 |
| 110 | Accellacare - Charlotte | Charlotte | North Carolina | United States | 28209 |
| 111 | Tryon Medical Partners, PLLC | Charlotte | North Carolina | United States | 28210 |
| 112 | Sensenbrenner Primary Care Research Office | Charlotte | North Carolina | United States | 28277 |
| 113 | Accellacare - Wilmington | Wilmington | North Carolina | United States | 28401 |
| 114 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 115 | Meridian Clinical Research | Cincinnati | Ohio | United States | 45219 |
| 116 | Velocity Clinical Research - Cincinnati | Cincinnati | Ohio | United States | 45242 |
| 117 | Meridian Clinical Research | Cincinnati | Ohio | United States | 45246 |
| 118 | Aventiv Research Inc | Columbus | Ohio | United States | 43213 |
| 119 | Tekton Research, Inc. | Edmond | Oklahoma | United States | 73013 |
| 120 | Tekton Research, Inc. | Yukon | Oklahoma | United States | 73099 |
| 121 | The Corvallis Clinic, PC | Corvallis | Oregon | United States | 97330 |
| 122 | Velocity Clinical Research, Grants Pass | Grants Pass | Oregon | United States | 97527 |
| 123 | Velocity Clinical Research, Medford | Medford | Oregon | United States | 97504 |
| 124 | Summit Headlands, LLC | Portland | Oregon | United States | 97210 |
| 125 | Kaiser Permanente Northwest-Center for Health Research | Portland | Oregon | United States | 97227 |
| 126 | Capital Area Research, LLC | Camp Hill | Pennsylvania | United States | 17011 |
| 127 | Central Erie Primary Care | Erie | Pennsylvania | United States | 16508 |
| 128 | West Shore Family Practice, P. C. | Mechanicsburg | Pennsylvania | United States | 17050 |
| 129 | Penn Prevention Unit | Philadelphia | Pennsylvania | United States | 19104 |
| 130 | Velocity Clinical Research, Providence | East Greenwich | Rhode Island | United States | 02818 |
| 131 | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | United States | 37909 |
| 132 | Accellacare US Inc., d/b/a Accellacare of Knoxville | Knoxville | Tennessee | United States | 37912 |
| 133 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
| 134 | Benchmark Research | Austin | Texas | United States | 78705 |
| 135 | ARC Clinical Research at Wilson Parke | Austin | Texas | United States | 78726 |
| 136 | Tekton Research, Inc. | Austin | Texas | United States | 78745 |
| 137 | Tekton Research, Inc. | Beaumont | Texas | United States | 77706 |
| 138 | North Texas Infectious Diseases Consultants, P.A | Dallas | Texas | United States | 75246 |
| 139 | Benchmark Research | Fort Worth | Texas | United States | 76135 |
| 140 | Allure Health at Mt. Olympus Medical Research | Friendswood | Texas | United States | 77546 |
| 141 | Hany H. Ahmed, MD | Houston | Texas | United States | 77008 |
| 142 | HG Pediatrics | Houston | Texas | United States | 77008 |
| 143 | Trio Clinical Trials, LLC | Houston | Texas | United States | 77008 |
| 144 | Van Tran Family Practice | Houston | Texas | United States | 77008 |
| 145 | Ventavia Research Group, LLC | Houston | Texas | United States | 77008 |
| 146 | Centex Studies | Houston | Texas | United States | 77058 |
| 147 | DM Clinical Research ? CyFair | Houston | Texas | United States | 77065 |
| 148 | Texas Center for Drug Development, Inc. | Houston | Texas | United States | 77081 |
| 149 | Centex Studies | Houston | Texas | United States | 77090 |
| 150 | DM Clinical Research | Humble | Texas | United States | 77338 |
| 151 | Milton Haber, M.D. | Laredo | Texas | United States | 78041 |
| 152 | SMS Clinical Research | Mesquite | Texas | United States | 75149 |
| 153 | Clinical Trials of Texas, LLC | San Antonio | Texas | United States | 78213 |
| 154 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
| 155 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
| 156 | Dynamed Clinical Research, LP d/b/a DM Clinical Research | Sugar Land | Texas | United States | 77478 |
| 157 | Javara Inc. | Sugar Land | Texas | United States | 77478 |
| 158 | Privia Medical Group Gulf Coast, PLLC | Sugar Land | Texas | United States | 77478 |
| 159 | Mt Olympus Medical Research | Sugar Land | Texas | United States | 77479 |
| 160 | Javara Inc. | The Woodlands | Texas | United States | 77382 |
| 161 | Privia Medical Group Gulf Coast, PLLC | The Woodlands | Texas | United States | 77382 |
| 162 | Martin Diagnostic Clinic | Tomball | Texas | United States | 77375 |
| 163 | J. Lewis Research Inc. / Foothill Family Clinic Draper | Draper | Utah | United States | 84020 |
| 164 | Tanner Clinic | Layton | Utah | United States | 84041 |
| 165 | J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | United States | 84095 |
| 166 | Velocity Clinical Research, Salt Lake City | West Jordan | Utah | United States | 84088 |
| 167 | Suffolk Multispecialty Research | Suffolk | Virginia | United States | 23435 |
| 168 | Virginia Gastroenterology Clinical Research | Suffolk | Virginia | United States | 23435 |
| 169 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
| 170 | Sound Medical Research | Port Orchard | Washington | United States | 98366 |
| 171 | MultiCare Institute for Research & Innovation | Tacoma | Washington | United States | 98405 |
| 172 | MultiCare Medical Group | Tacoma | Washington | United States | 98405 |
| 173 | Wenatchee Valley Hospital | Wenatchee | Washington | United States | 98801 |
| 174 | Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin | United States | 53226 |
| 175 | Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich | Caba | Buenos Aires | Argentina | 1426 |
| 176 | Fundación Respirar | Caba | Buenos Aires | Argentina | C1426ABP |
| 177 | Clinica Privada Instituto Medico Platense S.A. | La Plata | Buenos Aires | Argentina | B1900AVG |
| 178 | Instituto De Investigaciones Clínicas Mar Del Plata | Mar del Plata | Buenos Aires | Argentina | B7600FZO |
| 179 | Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
| 180 | Hospital de Clinicas Presidente Nicolas Avellaneda | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
| 181 | Clínica Mayo | San Miguel de Tucuman | Tucumán | Argentina | 4000 |
| 182 | Clinica Privada del Sol S.A. | Cordoba | Argentina | 5000 | |
| 183 | IMAC - Instituto Medico de Alta Complejidad | Salta | Argentina | 4400 | |
| 184 | Kaye Edmonton Clinic | Edmonton | Alberta | Canada | T6G 1Z1 |
| 185 | Stollery Children's Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 186 | Aggarwal and Associates Limited | Brampton | Ontario | Canada | L6T 0G1 |
| 187 | Dawson Clinical Research Inc. | Guelph | Ontario | Canada | N1H 1B1 |
| 188 | Hamilton Medical Research Group | Hamilton | Ontario | Canada | L8M 1K7 |
| 189 | LMC Clinical Research Inc. (Clinical Pharmacology Unit) | Toronto | Ontario | Canada | M4G 3E8 |
| 190 | Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | Ontario | Canada | M9V 4B4 |
| 191 | Manna Research (Toronto) | Toronto | Ontario | Canada | M9W 4L6 |
| 192 | Manna Research (Mirabel) | Mirabel | Quebec | Canada | J7J 2K8 |
| 193 | Clinique de Médecine Urbaine du Quartier Latin | Montreal | Quebec | Canada | H2L 4E9 |
| 194 | Alpha Recherche Clinique | Québec | Quebec | Canada | G2J 0C4 |
| 195 | Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1L 0H8 |
| 196 | Diex Recherche Joliette Inc. | St-Charles-Borromee | Quebec | Canada | J6E 2B4 |
| 197 | Diex Recherche Victoriaville Inc. | Victoriaville | Quebec | Canada | G6P 6P6 |
| 198 | Diex Recherche Quebec Inc. | Quebec | Canada | G1N 4V3 | |
| 199 | Centre de Recherche Saint-Louis | Quebec | Canada | G1W 4R4 | |
| 200 | Espoo Vaccine Research Clinic | Espoo | Finland | 02230 | |
| 201 | Helsinki South Vaccine Research Clinic | Helsinki | Finland | 00100 | |
| 202 | Helsinki East Vaccine Research Clinic | Helsinki | Finland | 00930 | |
| 203 | Terveystalo Jyväskylä | Jyväskylä | Finland | 40100 | |
| 204 | Järvenpää Vaccine Research Clinic | Järvenpää | Finland | 04400 | |
| 205 | Kokkola Vaccine Research Clinic | Kokkola | Finland | 67100 | |
| 206 | Oulu Vaccine Research Clinic | Oulu | Finland | 90220 | |
| 207 | Pori Vaccine Research Clinic | Pori | Finland | 28100 | |
| 208 | Seinäjoki Vaccine Research Clinic | Seinajoki | Finland | 60100 | |
| 209 | Tampere Vaccine Research Clinic | Tampere | Finland | 33100 | |
| 210 | Terveystalo Tampere | Tampere | Finland | 33100 | |
| 211 | Terveystalo Turku Pulssi | Turku | Finland | 20100 | |
| 212 | Turku Vaccine Research Clinic | Turku | Finland | 20520 | |
| 213 | Tenjin General Clinic | Fukuoka-shi | Fukuoka | Japan | 810-0021 |
| 214 | Seishinkai Inoue Hospital | Itoshima | Fukuoka | Japan | 819-1104 |
| 215 | Sasaki Clinic | Amagasaki | Hyōgo | Japan | 660-0827 |
| 216 | Motomachi Takatsuka Naika Clinic | Yokohama | Kanagawa | Japan | 231-0023 |
| 217 | Medical Corporation Heishinkai OPHAC Hospital | Osaka-shi | Osaka | Japan | 532-0003 |
| 218 | Sugiura Clinic | Kawaguchi-shi | Saitama | Japan | 332-0012 |
| 219 | Sugiura Clinic | Kawaguchi | Saitama | Japan | 332-0012 |
| 220 | Nihonbashi Sakura Clinic | Chuo-ku | Tokyo | Japan | 103-0025 |
| 221 | Tokyo Eki Center Building Clinic | Chuo-ku | Tokyo | Japan | 103-0027 |
| 222 | Fukuwa Clinic | Chuo-ku | Tokyo | Japan | 104-0031 |
| 223 | Tokyo Asbo Clinic | Chuo-ku | Tokyo | Japan | 104-0031 |
| 224 | Medical Corp. Seikoukai New Medical Research System Clinic | Hachioji-shi | Tokyo | Japan | 192-0046 |
| 225 | Hillside Clinic Jingumae | Shibuya-ku | Tokyo | Japan | 1500001 |
| 226 | Clinical Research Hospital Tokyo | Shinjuku-ku | Tokyo | Japan | 162-0053 |
| 227 | Oda Clinic | Shinjuku-ku | Tokyo | Japan | 169-0072 |
| 228 | Souseikai Sumida Hospital | Sumida-ku | Tokyo | Japan | 130-0004 |
| 229 | Sekino Hospital | Toshima-ku | Tokyo | Japan | 171-0014 |
| 230 | PS Clinic | Fukuoka | Japan | 812-0025 | |
| 231 | AMC Nishiumeda Clinic | Osaka | Japan | 530-0001 | |
| 232 | Sone Clinic | Tokyo | Japan | 160-0022 | |
| 233 | Meander Medisch Centrum | Amersfoort | Netherlands | 3813 TZ | |
| 234 | PoliDirect Amsterdam West | Amsterdam | Netherlands | 1064 BP | |
| 235 | Huisartsencentrum Parklaan | Eindhoven | Netherlands | 5613 BE | |
| 236 | Huisartsenpraktijk Radesingel | Groningen | Netherlands | 9718 TA | |
| 237 | Gezondheidscentrum Leonardus | Helmond | Netherlands | 5701 AH | |
| 238 | Spaarne Gasthuis | Hoofddorp | Netherlands | 2134 TM | |
| 239 | PoliDirect Nieuwegein | Nieuwegein | Netherlands | 3431 HR | |
| 240 | Franciscus Gasthuis & Vlietland, location Gasthuis | Rotterdam | Netherlands | 3045 PM | |
| 241 | Huisartsen Soest | Soest | Netherlands | 3762BN | |
| 242 | UMC Utrecht | Utrecht | Netherlands | 3584 CX | |
| 243 | Julius Clinical Breda | Zeist | Netherlands | 3703 CD | |
| 244 | Josha Research | Bloemfontein | FREE State | South Africa | 9301 |
| 245 | Welkom Clinical Trial Centre (MERC WELKOM) | Welkom | FREE State | South Africa | 9460 |
| 246 | Worthwhile Clinical Trials | Benoni | Gauteng | South Africa | 1500 |
| 247 | MERC Research (Pty) Ltd - Kempton | Kempton Park | Gauteng | South Africa | 1619 |
| 248 | Dr A Jacovides & Partners Inc. | Midrand | Gauteng | South Africa | 1685 |
| 249 | Newtown Clinical Research Centre (PTY) LTD | Newtown | Gauteng | South Africa | 2001 |
| 250 | Emmed Research | Pretoria | Gauteng | South Africa | 0002 |
| 251 | About Allergy-Bon Accord Centre | Pretoria | Gauteng | South Africa | 0009 |
| 252 | Global Clinical Trials | Pretoria | Gauteng | South Africa | 0083 |
| 253 | Botho Ke Bontle Health Services | Pretoria | Gauteng | South Africa | 0122 |
| 254 | About Allergy | Pretoria | Gauteng | South Africa | 0181 |
| 255 | Into Research | Pretoria | Gauteng | South Africa | 0181 |
| 256 | Setshaba Research Centre | Soshanguve | Gauteng | South Africa | 0152 |
| 257 | Wits Vaccines & Infectious Diseases Analytics | Soweto | Gauteng | South Africa | 2195 |
| 258 | FCRN Clinical Trial Centre | Vereeniging | Gauteng | South Africa | 1935 |
| 259 | MERC Research (Pty) Ltd - Middelburg | Middelburg | Mpumalanga | South Africa | 1055 |
| 260 | TREAD Research | Cape Town | Western CAPE | South Africa | 7500 |
| 261 | Be Part Yoluntu Centre | Paarl | Western CAPE | South Africa | 7626 |
| 262 | Helderberg Clinical Trials Centre | Somerset West | Western CAPE | South Africa | 7129 |
| 263 | Jongaie Research | Pretoria | South Africa | 0183 | |
| 264 | Synexus SA- Watermeyer Clinical Research Center | Pretoria | South Africa | 0184 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C3671013
- 2021-003693-31