20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04379713
Collaborator
(none)
1,513
97
2
27.3
15.6
0.6
Study Details
Study Description
Brief Summary
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1513 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Actual Study Start Date
:
May 21, 2020
Anticipated Primary Completion Date
:
Aug 31, 2022
Anticipated Study Completion Date
:
Aug 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine |
Biological: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
|
| Active Comparator: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine |
Biological: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants reporting prompted local reactions within 7 days after each dose in each group (redness, swelling, and pain at the injection site) [Day 7]
Prompted local reactions after each dose in each group
- Percentage of participants reporting prompted systemic events within 7 days after each dose in each group (fever, decreased appetite, irritability, and drowsiness/increased sleep) [Day 7]
Prompted systemic reactions after each dose in each group
- Percentage of participants reporting adverse events from Dose 1 through 1 month after Dose 3 in each group [1 month after Dose 3]
Adverse events occurring from Dose 1 through 1 month after Dose 3 in each group
- Percentage of participants reporting adverse events from Dose 4 through 1 month after Dose 4 in each group [1 month after Dose 4]
Adverse events occurring from Dose 4 through 1 month after Dose 4 in each group
- Percentage of participants reporting SAEs up to 6 months after Dose 4 in each group [6 months after Dose 4]
SAEs occurring up to 6 months after Dose 4 in each group
- Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group [6 months after Dose 4]
NDCMCs occurring up to 6 months after Dose 4 in each group
Eligibility Criteria
Criteria
Ages Eligible for Study:
42 Days
to 98 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
-
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria:
-
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
-
Major known congenital malformation or serious chronic disorder.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eclipse Clinical Research | Tucson | Arizona | United States | 85745 |
| 2 | Good Samaritan Family Health Team | Fullerton | California | United States | 92831 |
| 3 | FocilMed | Oxnard | California | United States | 93030 |
| 4 | Superior Research, LLC | Sacramento | California | United States | 95831 |
| 5 | Carey Chronis, MD | Ventura | California | United States | 93003 |
| 6 | Fomat - Robert Nudelman MD | Westlake Village | California | United States | 91361 |
| 7 | Ebert Family Clinic | Frisco | Colorado | United States | 80443 |
| 8 | Advanced Research for Health Improvement, LLC | Fort Myers | Florida | United States | 33907 |
| 9 | Pensacola Pediatrics | Gulf Breeze | Florida | United States | 32563 |
| 10 | Y&L Advance Health Care Inc, d/b/a Elite | Miami | Florida | United States | 33144 |
| 11 | Advanced Research for Health Improvement, LLC | Naples | Florida | United States | 34102 |
| 12 | Citadelle Clinical Research | North Miami Beach | Florida | United States | 33162 |
| 13 | Avanza Medical Research Center | Pensacola | Florida | United States | 32503 |
| 14 | Pensacola Pediatrics | Pensacola | Florida | United States | 32504 |
| 15 | KIDZ Medical Services Pediatric Pulmonary Center | South Miami | Florida | United States | 33143 |
| 16 | Teena Hughes/PAS Research | Tampa | Florida | United States | 33613 |
| 17 | Idaho Falls Pediatrics | Ammon | Idaho | United States | 83406 |
| 18 | Elite Clinical Trials LLLP | Blackfoot | Idaho | United States | 83221 |
| 19 | Idaho Falls Pediatrics | Idaho Falls | Idaho | United States | 83402 |
| 20 | Clinical Research Prime | Idaho Falls | Idaho | United States | 83404 |
| 21 | The Pediatric Center | Idaho Falls | Idaho | United States | 83404 |
| 22 | Cotton O'Neil Clinical Research Center, Pediatrics | Topeka | Kansas | United States | 66604 |
| 23 | All Children Pediatrics | Louisville | Kentucky | United States | 40243 |
| 24 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 25 | MedClinical Research Partners, LLC | East Orange | New Jersey | United States | 07018 |
| 26 | Advantage Clinical Trials | Bronx | New York | United States | 10468 |
| 27 | Pediatric Partners, PA | Raleigh | North Carolina | United States | 27609 |
| 28 | PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare | Statesville | North Carolina | United States | 28625 |
| 29 | Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network) | Winston-Salem | North Carolina | United States | 27103 |
| 30 | PMG Research of Winston-Salem | Winston-Salem | North Carolina | United States | 27103 |
| 31 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
| 32 | Coastal Pediatric Research | Summerville | South Carolina | United States | 29486 |
| 33 | The Jackson Clinic, PA | Jackson | Tennessee | United States | 38305 |
| 34 | Advent Health Family Medicine Rural Health Clinics, Inc. | Lampasas | Texas | United States | 76550 |
| 35 | FMC Science | Lampasas | Texas | United States | 76550 |
| 36 | Maximos Ob/Gyn | League City | Texas | United States | 77573 |
| 37 | Rio Grande Valley Clinical Research Institute | Pharr | Texas | United States | 78577 |
| 38 | Tanner Clinic | Layton | Utah | United States | 84041 |
| 39 | Wasatch Pediatrics - St. Marks Office | Salt Lake City | Utah | United States | 84124 |
| 40 | CopperView Medical Center | South Jordan | Utah | United States | 84095 |
| 41 | PI-Coor Clinical Research LLC | Burke | Virginia | United States | 22015 |
| 42 | Clinica Mayo UMCB S.R.L. | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
| 43 | Hospital del Nino Jesus | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
| 44 | Centro Medico Dra. De Salvo | Buenos Aires | Argentina | C1426ABP | |
| 45 | Aggarwal and Associates Limited | Brampton | Ontario | Canada | L6T 0G1 |
| 46 | Dawson Clinical Research Inc. | Guelph | Ontario | Canada | N1H 1B1 |
| 47 | Milestone Research , Inc | London | Ontario | Canada | N5W 6A2 |
| 48 | Bluewater Clinical Research Group Inc. | Sarnia | Ontario | Canada | N7T 4X3 |
| 49 | Dr. Hartley Garfield Medicine Professional Corporation | Toronto | Ontario | Canada | M5G 1N8 |
| 50 | Centre hospitalier universitaire (CHU) Sainte-Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 51 | McGill University Health Centre, Vaccine Study Centre | Pierrefonds | Quebec | Canada | H9H 4Y6 |
| 52 | CHU de Quebec-Universite Laval | Québec City | Quebec | Canada | G1E 7G9 |
| 53 | CESFAM Colina | Colina, Santiago | Región Metropolitana | Chile | 9350079 |
| 54 | CESFAM Esmeralda | Colina, Santiago | Región Metropolitana | Chile | |
| 55 | Biocinetic | Santiago | Región Metropolitana | Chile | 8331143 |
| 56 | Grupo Estudios Clínicos Infectología Respiratoria | Santiago | Región Metropolitana | Chile | 8380453 |
| 57 | Hospital Padre Hurtado | Santiago | Región Metropolitana | Chile | 8880465 |
| 58 | Ordinace praktickeho lekare pro deti a dorost | Hradec Kralove | Czechia | 50004 | |
| 59 | Ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec II | Czechia | 377 01 | |
| 60 | Detska ambulance Petriny spol. s r.o. | Veleslavin | Czechia | 162 00 | |
| 61 | MeVac, Meilahti Vaccine Research Center | Helsinki | Finland | 00290 | |
| 62 | SIBAmed GmbH & Co.KG | Leipzig | Saxony | Germany | 04103 |
| 63 | Kinderarztpraxis Bramsche | Bramsche | Germany | 49565 | |
| 64 | Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel | Herford | Germany | 32049 | |
| 65 | Praxis fuer Kinderpneumologie und Allergologie Mannheim | Mannheim | Germany | 68161 | |
| 66 | Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott | Mönchengladbach | Germany | 41236 | |
| 67 | Praxis Dr. med. Joachim Weimer | Reinfeld | Germany | 23858 | |
| 68 | University General Hospital of Heraklion | Heraklion | Crete | Greece | 71110 |
| 69 | General University Hospital of Larissa | Larissa | Thessaly | Greece | 41110 |
| 70 | "Aghia Sophia" Children's Hospital | Athens | Greece | 11527 | |
| 71 | P. and A. Kyriakou Children's Hospital | Athens | Greece | 11527 | |
| 72 | University General Hospital "ATTIKON" | Athens | Greece | 12462 | |
| 73 | "Ippokratio" General Hospital of Thessaloniki | Thessaloniki | Greece | 54642 | |
| 74 | Papp és Tsa Eü és Szolg Bt | Szigetvar | Baranya | Hungary | 7900 |
| 75 | Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely | Szombathely | VAS Megye | Hungary | 9700 |
| 76 | Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő | Budapest | Hungary | 1042 | |
| 77 | Futurenest Kft. Pestszentimrei Gyermekrendelő | Budapest | Hungary | 1188 | |
| 78 | Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis | Csongrad | Hungary | 6640 | |
| 79 | Futurenest Kft. 16. házi gyermekorvosi rendelő | Debrecen | Hungary | 4025 | |
| 80 | Mimiped Bt | Gyor | Hungary | 9024 | |
| 81 | Futurenest Kft | Miskolc | Hungary | 3527 | |
| 82 | Bettimedical BT | Szazhalombatta | Hungary | 2440 | |
| 83 | Ponce Medical School Foundation Inc./ CAIMED Center | Ponce | Puerto Rico | 00176 | |
| 84 | CHUS - Hospital Clinico Universitario | Santiago de Compostela | A Coruna | Spain | 15706 |
| 85 | Hospital Universitari General de Catalunya | Sant Cugat del Valles | Barcelona | Spain | 08195 |
| 86 | Centro de Salud de Burriana II | Burriana | Castellon | Spain | 12530 |
| 87 | Hospital Universitario de Burgos | Burgos | Castilla Y LEON | Spain | 09006 |
| 88 | Hospital Universitario HM Monteprincipe | Boadilla del Monte | Madrid | Spain | 28660 |
| 89 | Centro de Salud L'Eliana | L'Eliana | Valencia | Spain | 46183 |
| 90 | Centro de Salud de Paiporta | Paiporta | Valencia | Spain | 46200 |
| 91 | Clinica Corachan | Barcelona | Spain | 08017 | |
| 92 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 93 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 94 | Grupo Pediatrico Uncibay | Malaga | Spain | 29015 | |
| 95 | Centro de Salud de Malvarrosa | Valencia | Spain | 46011 | |
| 96 | FISABIO | Valencia | Spain | 46020 | |
| 97 | Centro de Salud la Serreria II | Valencia | Spain | 46022 |
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.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04379713
Other Study ID Numbers:
- B7471013
- 2019-003307-35
First Posted:
May 7, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: