20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

NCT04379713 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B74710132019-003307-35
• Study Type: interventional
• Target: 1,511
• Locations: 11 countries
• Sites: 97

Brief Summary

This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  From Dose 1 to 6 Months after Dose 4

Study Arms (2)

20-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Pneumococcal conjugate vaccine

Biological: 20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

ACTIVE COMPARATOR

Pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

20-valent pneumococcal conjugate vaccine BIOLOGICAL

Pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine BIOLOGICAL

Pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
• Major known congenital malformation or serious chronic disorder.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (97)

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Good Samaritan Family Health Team

Fullerton, California, 92831, United States

Location

FocilMed

Oxnard, California, 93030, United States

Location

Superior Research, LLC

Sacramento, California, 95831, United States

Location

Carey Chronis, MD

Ventura, California, 93003, United States

Location

Fomat - Robert Nudelman MD

Westlake Village, California, 91361, United States

Location

Ebert Family Clinic

Frisco, Colorado, 80443, United States

Location

Advanced Research for Health Improvement, LLC

Fort Myers, Florida, 33907, United States

Location

Pensacola Pediatrics

Gulf Breeze, Florida, 32563, United States

Location

Y&L Advance Health Care Inc, d/b/a Elite

Miami, Florida, 33144, United States

Location

Advanced Research for Health Improvement, LLC

Naples, Florida, 34102, United States

Location

Citadelle Clinical Research

North Miami Beach, Florida, 33162, United States

Location

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

Pensacola Pediatrics

Pensacola, Florida, 32504, United States

Location

KIDZ Medical Services Pediatric Pulmonary Center

South Miami, Florida, 33143, United States

Location

Teena Hughes/PAS Research

Tampa, Florida, 33613, United States

Location

Idaho Falls Pediatrics

Ammon, Idaho, 83406, United States

Location

Elite Clinical Trials LLLP

Blackfoot, Idaho, 83221, United States

Location

Idaho Falls Pediatrics

Idaho Falls, Idaho, 83402, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

The Pediatric Center

Idaho Falls, Idaho, 83404, United States

Location

Cotton O'Neil Clinical Research Center, Pediatrics

Topeka, Kansas, 66604, United States

Location

All Children Pediatrics

Louisville, Kentucky, 40243, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MedClinical Research Partners, LLC

East Orange, New Jersey, 07018, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10468, United States

Location

Pediatric Partners, PA

Raleigh, North Carolina, 27609, United States

Location

PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare

Statesville, North Carolina, 28625, United States

Location

Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)

Winston-Salem, North Carolina, 27103, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

Location

The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States

Location

Advent Health Family Medicine Rural Health Clinics, Inc.

Lampasas, Texas, 76550, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

Rio Grande Valley Clinical Research Institute

Pharr, Texas, 78577, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Wasatch Pediatrics - St. Marks Office

Salt Lake City, Utah, 84124, United States

Location

CopperView Medical Center

South Jordan, Utah, 84095, United States

Location

PI-Coor Clinical Research LLC

Burke, Virginia, 22015, United States

Location

Clinica Mayo UMCB S.R.L.

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Hospital del Nino Jesus

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro Medico Dra. De Salvo

Buenos Aires, C1426ABP, Argentina

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Dawson Clinical Research Inc.

Guelph, Ontario, N1H 1B1, Canada

Location

Milestone Research , Inc

London, Ontario, N5W 6A2, Canada

Location

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, N7T 4X3, Canada

Location

Dr. Hartley Garfield Medicine Professional Corporation

Toronto, Ontario, M5G 1N8, Canada

Location

Centre hospitalier universitaire (CHU) Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

McGill University Health Centre, Vaccine Study Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

CHU de Quebec-Universite Laval

Québec, Quebec, G1E 7G9, Canada

Location

CESFAM Colina

Colina, Santiago, Santiago Metropolitan, 9350079, Chile

Location

CESFAM Esmeralda

Colina, Santiago, Santiago Metropolitan, Chile

Location

Biocinetic

Santiago, Santiago Metropolitan, 8331143, Chile

Location

Grupo Estudios Clínicos Infectología Respiratoria

Santiago, Santiago Metropolitan, 8380453, Chile

Location

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, 8880465, Chile

Location

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, 50004, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindrichuv Hradec II, 377 01, Czechia

Location

Detska ambulance Petriny spol. s r.o.

Veleslavín, 162 00, Czechia

Location

MeVac - Meilahti Vaccine Research Center

Helsinki, 00290, Finland

Location

SIBAmed GmbH & Co.KG

Leipzig, Saxony, 04103, Germany

Location

Kinderarztpraxis Bramsche

Bramsche, 49565, Germany

Location

Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel

Herford, 32049, Germany

Location

Praxis fuer Kinderpneumologie und Allergologie Mannheim

Mannheim, 68161, Germany

Location

Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott

Mönchengladbach, 41236, Germany

Location

Praxis Dr. med. Joachim Weimer

Reinfeld, 23858, Germany

Location

University General Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

General University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

"Aghia Sophia" Children's Hospital

Athens, 11527, Greece

Location

P. and A. Kyriakou Children's Hospital

Athens, 11527, Greece

Location

University General Hospital "ATTIKON"

Athens, 12462, Greece

Location

"Ippokratio" General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

Papp és Tsa Eü és Szolg Bt

Szigetvár, Baranya, 7900, Hungary

Location

Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely

Szombathely, Vas County, 9700, Hungary

Location

Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő

Budapest, 1042, Hungary

Location

Futurenest Kft. Pestszentimrei Gyermekrendelő

Budapest, 1188, Hungary

Location

Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis

Csongrád, 6640, Hungary

Location

Futurenest Kft. 16. házi gyermekorvosi rendelő

Debrecen, 4025, Hungary

Location

Mimiped Bt

Győr, 9024, Hungary

Location

Futurenest Kft

Miskolc, 3527, Hungary

Location

Bettimedical BT

Százhalombatta, 2440, Hungary

Location

Ponce Medical School Foundation Inc./ CAIMED Center

Ponce, 00176, Puerto Rico

Location

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Centro de Salud de Burriana II

Burriana, Castellon, 12530, Spain

Location

Hospital Universitario de Burgos

Burgos, Castille and León, 09006, Spain

Location

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Centro de Salud L'Eliana

L'Eliana, Valencia, 46183, Spain

Location

Centro de Salud de Paiporta

Paiporta, Valencia, 46200, Spain

Location

Clinica Corachan

Barcelona, 08017, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Grupo Pediatrico Uncibay

Málaga, 29015, Spain

Location

Centro de Salud de Malvarrosa

Valencia, 46011, Spain

Location

FISABIO

Valencia, 46020, Spain

Location

Centro de Salud la Serreria II

Valencia, 46022, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 7, 2020
• Study Start: May 21, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (41); CL (5); PR (1); CZ (3); ES (14); CA (8); AR (3); HU (9); FI (1); DE (6); GR (6)