20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 13-valent pneumococcal conjugate vaccineBiological: 20-valent pneumococcal conjugate vaccine
- Registration Number
- NCT04379713
- Lead Sponsor
- Pfizer
- Brief Summary
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1511
- 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.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Major known congenital malformation or serious chronic disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine
- Primary Outcome Measures
Name Time Method Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Within 7 Days after Dose 3 Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Within 7 Days after Dose 4 Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Within 7 Days after Dose 3 Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Within 7 Days after Dose 4 Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Within 7 Days after Dose 2 Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4 From Dose 1 to 6 Months after Dose 4 An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Within 7 Days after Dose 1 Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Within 7 Days after Dose 2 Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4 From Dose 1 to 6 Months after Dose 4 A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Within 7 Days after Dose 1 Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 From Dose 4 to 1 Month after Dose 4 An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 From Dose 1 to 1 Month after Dose 3 An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. 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
Trial Locations
- Locations (93)
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Idaho Falls Pediatrics
🇺🇸Idaho Falls, Idaho, United States
Mimiped Bt
🇭🇺Gyor, Hungary
Cotton O'Neil Clinical Research Center, Pediatrics
🇺🇸Topeka, Kansas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Kinderarztpraxis Bramsche
🇩🇪Bramsche, Germany
CESFAM Colina
🇨🇱Colina, Santiago, Región Metropolitana, Chile
Grupo Estudios Clínicos Infectología Respiratoria
🇨🇱Santiago, Región Metropolitana, Chile
University General Hospital of Heraklion
🇬🇷Heraklion, Crete, Greece
"Aghia Sophia" Children's Hospital
🇬🇷Athens, Greece
P. and A. Kyriakou Children's Hospital
🇬🇷Athens, Greece
Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
🇭🇺Szombathely, VAS Megye, Hungary
MeVac - Meilahti Vaccine Research Center
🇫🇮Helsinki, Finland
University General Hospital "ATTIKON"
🇬🇷Athens, Greece
Biocinetic
🇨🇱Santiago, Región Metropolitana, Chile
Bettimedical BT
🇭🇺Szazhalombatta, Hungary
SIBAmed GmbH & Co.KG
🇩🇪Leipzig, Saxony, Germany
General University Hospital of Larissa
🇬🇷Larissa, Thessaly, Greece
"Ippokratio" General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Futurenest Kft
🇭🇺Miskolc, Hungary
Papp és Tsa Eü és Szolg Bt
🇭🇺Szigetvar, Baranya, Hungary
Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
🇭🇺Csongrad, Hungary
Futurenest Kft. Pestszentimrei Gyermekrendelő
🇭🇺Budapest, Hungary
Futurenest Kft. 16. házi gyermekorvosi rendelő
🇭🇺Debrecen, Hungary
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Dawson Clinical Research Inc.
🇨🇦Guelph, Ontario, Canada
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
Good Samaritan Family Health Team
🇺🇸Fullerton, California, United States
FocilMed
🇺🇸Oxnard, California, United States
Superior Research, LLC
🇺🇸Sacramento, California, United States
Carey Chronis, MD
🇺🇸Ventura, California, United States
Fomat - Robert Nudelman MD
🇺🇸Westlake Village, California, United States
Ebert Family Clinic
🇺🇸Frisco, Colorado, United States
Advanced Research for Health Improvement, LLC
🇺🇸Naples, Florida, United States
Pensacola Pediatrics
🇺🇸Pensacola, Florida, United States
Y&L Advance Health Care Inc, d/b/a Elite
🇺🇸Miami, Florida, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Citadelle Clinical Research
🇺🇸North Miami Beach, Florida, United States
KIDZ Medical Services Pediatric Pulmonary Center
🇺🇸South Miami, Florida, United States
Teena Hughes/PAS Research
🇺🇸Tampa, Florida, United States
The Pediatric Center
🇺🇸Idaho Falls, Idaho, United States
All Children Pediatrics
🇺🇸Louisville, Kentucky, United States
Elite Clinical Trials LLLP
🇺🇸Blackfoot, Idaho, United States
Advantage Clinical Trials
🇺🇸Bronx, New York, United States
Pediatric Partners, PA
🇺🇸Raleigh, North Carolina, United States
MedClinical Research Partners, LLC
🇺🇸East Orange, New Jersey, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
🇺🇸Winston-Salem, North Carolina, United States
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
🇺🇸Statesville, North Carolina, United States
Coastal Pediatric Research
🇺🇸Summerville, South Carolina, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
The Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
Maximos Ob/Gyn
🇺🇸League City, Texas, United States
Rio Grande Valley Clinical Research Institute
🇺🇸Pharr, Texas, United States
Advent Health Family Medicine Rural Health Clinics, Inc.
🇺🇸Lampasas, Texas, United States
FMC Science
🇺🇸Lampasas, Texas, United States
PI-Coor Clinical Research LLC
🇺🇸Burke, Virginia, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Wasatch Pediatrics - St. Marks Office
🇺🇸Salt Lake City, Utah, United States
CopperView Medical Center
🇺🇸South Jordan, Utah, United States
Clinica Mayo UMCB S.R.L.
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Milestone Research , Inc
🇨🇦London, Ontario, Canada
Hospital del Nino Jesus
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Centro Medico Dra. De Salvo
🇦🇷Buenos Aires, Argentina
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Dr. Hartley Garfield Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre, Vaccine Study Centre
🇨🇦Pierrefonds, Quebec, Canada
CHU de Quebec-Universite Laval
🇨🇦Québec City, Quebec, Canada
Centre hospitalier universitaire (CHU) Sainte-Justine
🇨🇦Montreal, Quebec, Canada
CESFAM Esmeralda
🇨🇱Colina, Santiago, Región Metropolitana, Chile
Hospital Padre Hurtado
🇨🇱Santiago, Región Metropolitana, Chile
Ordinace praktickeho lekare pro deti a dorost
🇨🇿Jindrichuv Hradec II, Czechia
Detska ambulance Petriny spol. s r.o.
🇨🇿Veleslavin, Czechia
Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
🇩🇪Herford, Germany
Praxis fuer Kinderpneumologie und Allergologie Mannheim
🇩🇪Mannheim, Germany
Praxis Dr. med. Joachim Weimer
🇩🇪Reinfeld, Germany
Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
🇩🇪Mönchengladbach, Germany
Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
🇭🇺Budapest, Hungary
Ponce Medical School Foundation Inc./ CAIMED Center
🇵🇷Ponce, Puerto Rico
Centro de Salud de Burriana II
🇪🇸Burriana, Castellon, Spain
CHUS - Hospital Clinico Universitario
🇪🇸Santiago de Compostela, A Coruna, Spain
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat del Valles, Barcelona, Spain
Hospital Universitario HM Monteprincipe
🇪🇸Boadilla del Monte, Madrid, Spain
Centro de Salud de Paiporta
🇪🇸Paiporta, Valencia, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Castilla Y LEON, Spain
Centro de Salud L'Eliana
🇪🇸L'Eliana, Valencia, Spain
Grupo Pediatrico Uncibay
🇪🇸Malaga, Spain
Clinica Corachan
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
FISABIO
🇪🇸Valencia, Spain
Centro de Salud de Malvarrosa
🇪🇸Valencia, Spain
Centro de Salud la Serreria II
🇪🇸Valencia, Spain