20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

May 18, 2023 updated by: Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1511

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Centro Médico Dra. De Salvo
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Clinica Mayo UMCB S.R.L.
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Hospital del Nino Jesus
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Limited
      • Guelph, Ontario, Canada, N1H 1B1
        • Dawson Clinical Research Inc.
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research , Inc
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Toronto, Ontario, Canada, M5G 1N8
        • Dr. Hartley Garfield Medicine Professional Corporation
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Centre Hospitalier Universitaire (CHU) Sainte-Justine
      • Pierrefonds, Quebec, Canada, H9H 4Y6
        • McGill University Health Centre, Vaccine Study Centre
      • Québec City, Quebec, Canada, G1E 7G9
        • CHU de Quebec-Universite Laval
  • Chile
    • Región Metropolitana
      • Colina, Santiago, Región Metropolitana, Chile, 9350079
        • CESFAM Colina
      • Colina, Santiago, Región Metropolitana, Chile
        • CESFAM Esmeralda
      • Santiago, Región Metropolitana, Chile, 8380453
        • Grupo Estudios Clínicos Infectología Respiratoria
      • Santiago, Región Metropolitana, Chile, 8880465
        • Hospital Padre Hurtado
      • Santiago, Región Metropolitana, Chile, 8331143
        • Biocinetic
  • Czechia
      • Hradec Kralove, Czechia, 50004
        • Ordinace praktického lékaře pro děti a dorost
      • Jindrichuv Hradec II, Czechia, 377 01
        • Ordinace praktického lékaře pro děti a dorost
      • Veleslavin, Czechia, 162 00
        • Detska ambulance Petriny spol. s r.o.
  • Finland
      • Helsinki, Finland, 00290
        • MeVac - Meilahti Vaccine Research Center
  • Germany
      • Bramsche, Germany, 49565
        • Kinderarztpraxis Bramsche
      • Herford, Germany, 32049
        • Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
      • Mannheim, Germany, 68161
        • Praxis fuer Kinderpneumologie und Allergologie Mannheim
      • Mönchengladbach, Germany, 41236
        • Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
      • Reinfeld, Germany, 23858
        • Praxis Dr. med. Joachim Weimer
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Sibamed GmbH & Co.KG
  • Greece
      • Athens, Greece, 12462
        • University General Hospital "Attikon"
      • Athens, Greece, 11527
        • "Aghia Sophia" Children's Hospital
      • Athens, Greece, 11527
        • P. and A. Kyriakou Children's Hospital
      • Thessaloniki, Greece, 54642
        • "Ippokratio" General Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University General Hospital of Heraklion
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • General University Hospital of Larissa
  • Hungary
      • Budapest, Hungary, 1042
        • Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
      • Budapest, Hungary, 1188
        • Futurenest Kft. Pestszentimrei Gyermekrendelő
      • Csongrad, Hungary, 6640
        • Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
      • Debrecen, Hungary, 4025
        • Futurenest Kft. 16. házi gyermekorvosi rendelő
      • Gyor, Hungary, 9024
        • Mimiped Bt
      • Miskolc, Hungary, 3527
        • Futurenest Kft
      • Szazhalombatta, Hungary, 2440
        • Bettimedical BT
    • Baranya
      • Szigetvar, Baranya, Hungary, 7900
        • Papp és Tsa Eü és Szolg Bt
    • VAS Megye
      • Szombathely, VAS Megye, Hungary, 9700
        • Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
  • Puerto Rico
      • Ponce, Puerto Rico, 00176
        • Ponce Medical School Foundation Inc./ CAIMED Center
  • Spain
      • Barcelona, Spain, 08017
        • Clínica Corachan
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Malaga, Spain, 29015
        • Grupo Pediátrico Uncibay
      • Valencia, Spain, 46020
        • FISABIO
      • Valencia, Spain, 46022
        • Centro de Salud la Serreria II
      • Valencia, Spain, 46011
        • Centro de Salud de Malvarrosa
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • CHUS - Hospital Clinico Universitario
    • Barcelona
      • Sant Cugat del Valles, Barcelona, Spain, 08195
        • Hospital Universitari General de Catalunya
    • Castellon
      • Burriana, Castellon, Spain, 12530
        • Centro de Salud de Burriana II
    • Castilla Y LEON
      • Burgos, Castilla Y LEON, Spain, 09006
        • Hospital Universitario de Burgos
    • Madrid
      • Boadilla del Monte, Madrid, Spain, 28660
        • Hospital Universitario HM Monteprincipe
    • Valencia
      • L'Eliana, Valencia, Spain, 46183
        • Centro de Salud L'Eliana
      • Paiporta, Valencia, Spain, 46200
        • Centro de Salud de Paiporta
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research
    • California
      • Fullerton, California, United States, 92831
        • Good Samaritan Family Health Team
      • Oxnard, California, United States, 93030
        • FocilMed
      • Sacramento, California, United States, 95831
        • Superior Research, LLC
      • Ventura, California, United States, 93003
        • Carey Chronis, MD
      • Westlake Village, California, United States, 91361
        • Fomat - Robert Nudelman MD
    • Colorado
      • Frisco, Colorado, United States, 80443
        • Ebert Family Clinic
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Advanced Research for Health Improvement, LLC
      • Gulf Breeze, Florida, United States, 32563
        • Pensacola Pediatrics
      • Miami, Florida, United States, 33144
        • Y&L Advance Health Care Inc, d/b/a Elite
      • Naples, Florida, United States, 34102
        • Advanced Research for Health Improvement, LLC
      • North Miami Beach, Florida, United States, 33162
        • Citadelle Clinical Research
      • Pensacola, Florida, United States, 32503
        • Avanza Medical Research Center
      • Pensacola, Florida, United States, 32504
        • Pensacola Pediatrics
      • South Miami, Florida, United States, 33143
        • KIDZ Medical Services Pediatric Pulmonary Center
      • Tampa, Florida, United States, 33613
        • Teena Hughes/PAS Research
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Idaho Falls Pediatrics
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials LLLP
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • The Pediatric Center
      • Idaho Falls, Idaho, United States, 83402
        • Idaho Falls Pediatrics
    • Kansas
      • Topeka, Kansas, United States, 66604
        • Cotton O'Neil Clinical Research Center, Pediatrics
    • Kentucky
      • Louisville, Kentucky, United States, 40243
        • All Children Pediatrics
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • MedClinical Research Partners, LLC
    • New York
      • Bronx, New York, United States, 10468
        • Advantage Clinical Trials
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Pediatric Partners, PA
      • Statesville, North Carolina, United States, 28625
        • PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem
      • Winston-Salem, North Carolina, United States, 27103
        • Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Coastal Pediatric Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic, PA
    • Texas
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • Lampasas, Texas, United States, 76550
        • Advent Health Family Medicine Rural Health Clinics, Inc.
      • League City, Texas, United States, 77573
        • Maximos Ob/Gyn
      • Pharr, Texas, United States, 78577
        • Rio Grande Valley Clinical Research Institute
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic
      • Salt Lake City, Utah, United States, 84124
        • Wasatch Pediatrics - St. Marks Office
      • South Jordan, Utah, United States, 84095
        • Copperview Medical Center
    • Virginia
      • Burke, Virginia, United States, 22015
        • PI-Coor Clinical Research LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Time Frame: 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.
Within 7 Days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Time Frame: 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.
Within 7 Days after Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Time Frame: 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.
Within 7 Days after Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Time Frame: 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.
Within 7 Days after Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Time Frame: 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).
Within 7 Days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Time Frame: 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).
Within 7 Days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Time Frame: 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).
Within 7 Days after Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Time Frame: 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).
Within 7 Days after Dose 4
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Time Frame: 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.
From Dose 1 to 1 Month after Dose 3
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
From Dose 1 to 6 Months after Dose 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7471013
  • 2019-003307-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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