Pneumococcal DiseasePhase 3NCT04379713
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
A Phase 3 study testing 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Disease, run by Pfizer at 97 sites in 11 countries.
Trial summary
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants. Read more about this study
- Who is it for?
- Ages 42 to 98 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 20-valent pneumococcal conjugate vaccine and 13-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,511 participants
- Where
- 97 sitesin 11 countries
- Study dates
- 21 May 2020to 31 Aug 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 98 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Major known congenital malformation or serious chronic disorder.
Trial locations and contacts
97 sites in 11 countries.
97 sites in 11 countries
United States41 sites
Idaho Falls Pediatrics
Ammon, Idaho, 83406
Elite Clinical Trials LLLP
Blackfoot, Idaho, 83221
Boston Medical Center
Boston, Massachusetts, 02118
PI-Coor Clinical Research LLC
Burke, Virginia, 22015
MedClinical Research Partners, LLC
East Orange, New Jersey, 07018
Advanced Research for Health Improvement, LLC
Fort Myers, Florida, 33907
Ebert Family Clinic
Frisco, Colorado, 80443
Good Samaritan Family Health Team
Fullerton, California, 92831
Pensacola Pediatrics
Gulf Breeze, Florida, 32563
Idaho Falls Pediatrics
Idaho Falls, Idaho, 83402
Clinical Research Prime
Idaho Falls, Idaho, 83404
The Pediatric Center
Idaho Falls, Idaho, 83404
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Advent Health Family Medicine Rural Health Clinics, Inc.
Lampasas, Texas, 76550
FMC Science
Lampasas, Texas, 76550
Tanner Clinic
Layton, Utah, 84041
Maximos Ob/Gyn
League City, Texas, 77573
All Children Pediatrics
Louisville, Kentucky, 40243
Y&L Advance Health Care Inc, d/b/a Elite
Miami, Florida, 33144
Advanced Research for Health Improvement, LLC
Naples, Florida, 34102
Citadelle Clinical Research
North Miami Beach, Florida, 33162
FocilMed
Oxnard, California, 93030
Avanza Medical Research Center
Pensacola, Florida, 32503
Pensacola Pediatrics
Pensacola, Florida, 32504
Rio Grande Valley Clinical Research Institute
Pharr, Texas, 78577
Pediatric Partners, PA
Raleigh, North Carolina, 27609
Superior Research, LLC
Sacramento, California, 95831
Wasatch Pediatrics - St. Marks Office
Salt Lake City, Utah, 84124
CopperView Medical Center
South Jordan, Utah, 84095
KIDZ Medical Services Pediatric Pulmonary Center
South Miami, Florida, 33143
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
Statesville, North Carolina, 28625
Coastal Pediatric Research
Summerville, South Carolina, 29486
Teena Hughes/PAS Research
Tampa, Florida, 33613
Advantage Clinical Trials
The Bronx, New York, 10468
Cotton O'Neil Clinical Research Center, Pediatrics
Topeka, Kansas, 66604
Eclipse Clinical Research
Tucson, Arizona, 85745
Carey Chronis, MD
Ventura, California, 93003
Omega Medical Research
Warwick, Rhode Island, 02886
Fomat - Robert Nudelman MD
Westlake Village, California, 91361
Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
Winston-Salem, North Carolina, 27103
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Spain14 sites
Clinica Corachan
Barcelona, 08017
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
Centro de Salud de Burriana II
Burriana, Castellon, 12530
Centro de Salud L'Eliana
L'Eliana, Valencia, 46183
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Grupo Pediatrico Uncibay
Málaga, 29015
Centro de Salud de Paiporta
Paiporta, Valencia, 46200
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruna, 15706
Centro de Salud de Malvarrosa
Valencia, 46011
FISABIO
Valencia, 46020
Centro de Salud la Serreria II
Valencia, 46022
Hungary9 sites
Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
Budapest, 1042
Futurenest Kft. Pestszentimrei Gyermekrendelő
Budapest, 1188
Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
Csongrád, 6640
Futurenest Kft. 16. házi gyermekorvosi rendelő
Debrecen, 4025
Mimiped Bt
Győr, 9024
Futurenest Kft
Miskolc, 3527
Bettimedical BT
Százhalombatta, 2440
Papp és Tsa Eü és Szolg Bt
Szigetvár, Baranya, 7900
Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
Szombathely, Vas County, 9700
Canada8 sites
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Dawson Clinical Research Inc.
Guelph, Ontario, N1H 1B1
Milestone Research , Inc
London, Ontario, N5W 6A2
Centre hospitalier universitaire (CHU) Sainte-Justine
Montreal, Quebec, H3T 1C5
McGill University Health Centre, Vaccine Study Centre
Pierrefonds, Quebec, H9H 4Y6
CHU de Quebec-Universite Laval
Québec, Quebec, G1E 7G9
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3
Dr. Hartley Garfield Medicine Professional Corporation
Toronto, Ontario, M5G 1N8
Germany6 sites
Kinderarztpraxis Bramsche
Bramsche, 49565
Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
Herford, 32049
SIBAmed GmbH & Co.KG
Leipzig, Saxony, 04103
Praxis fuer Kinderpneumologie und Allergologie Mannheim
Mannheim, 68161
Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
Mönchengladbach, 41236
Praxis Dr. med. Joachim Weimer
Reinfeld, 23858
Greece6 sites
"Aghia Sophia" Children's Hospital
Athens, 11527
P. and A. Kyriakou Children's Hospital
Athens, 11527
University General Hospital "ATTIKON"
Athens, 12462
University General Hospital of Heraklion
Heraklion, Crete, 71110
General University Hospital of Larissa
Larissa, Thessaly, 41110
"Ippokratio" General Hospital of Thessaloniki
Thessaloniki, 54642
Chile5 sites
CESFAM Colina
Colina, Santiago, Santiago Metropolitan, 9350079
CESFAM Esmeralda
Colina, Santiago, Santiago Metropolitan
Biocinetic
Santiago, Santiago Metropolitan, 8331143
Grupo Estudios Clínicos Infectología Respiratoria
Santiago, Santiago Metropolitan, 8380453
Hospital Padre Hurtado
Santiago, Santiago Metropolitan, 8880465
Argentina3 sites
Centro Medico Dra. De Salvo
Buenos Aires, C1426ABP
Clinica Mayo UMCB S.R.L.
San Miguel de Tucumán, Tucumán Province, 4000
Hospital del Nino Jesus
San Miguel de Tucumán, Tucumán Province, 4000
Czechia3 sites
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, 50004
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec II, 377 01
Detska ambulance Petriny spol. s r.o.
Veleslavín, 162 00
Puerto Rico1 site
Ponce Medical School Foundation Inc./ CAIMED Center
Ponce, 00176
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
- Conditions
- Pneumococcal Disease
- Being tested
- 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-valent pneumococcal conjugate vaccineBiological
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccineBiological
Pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine Receives: Biological: 20-valent pneumococcal conjugate vaccine |
| 13-valent pneumococcal conjugate vaccine | Active comparator | Pneumococcal conjugate vaccine Receives: Biological: 13-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Local Reactions 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.
Measured: Within 7 Days after Dose 1
Percentage of Participants With Local Reactions 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.
Measured: Within 7 Days after Dose 2
Percentage of Participants With Local Reactions 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.
Measured: Within 7 Days after Dose 3
Percentage of Participants With Local Reactions 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.
Measured: Within 7 Days after Dose 4
Percentage of Participants With Systemic Events 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).
Measured: Within 7 Days after Dose 1
Percentage of Participants With Systemic Events 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).
Measured: Within 7 Days after Dose 2
Percentage of Participants With Systemic Events 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).
Measured: Within 7 Days after Dose 3
Percentage of Participants With Systemic Events 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).
Measured: Within 7 Days after Dose 4
Percentage of Participants With Adverse Events (AEs) 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.
Measured: From Dose 1 to 1 Month after Dose 3
Percentage of Participants With AEs 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.
Measured: From Dose 4 to 1 Month after Dose 4
Percentage of Participants With Serious Adverse Events (SAEs) 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.
Measured: From Dose 1 to 6 Months after Dose 4
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) 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.
Measured: From Dose 1 to 6 Months after Dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start21 May 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379713
- Sponsor's protocol ID
- B7471013
- Other IDs
- 2019-003307-35, 2019
- Status last verified
- May 2023
- First submitted
- 6 May 2020
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.