20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

Pneumococcal Disease Clinical Trial

Official title:

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379713
• Other study ID #: B7471013
• Secondary ID: 2019-003307-35
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1511
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 98 Days

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
• 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine

Locations

Country	Name	City	State
Argentina	Centro Medico Dra. De Salvo	Buenos Aires
Argentina	Clinica Mayo UMCB S.R.L.	San Miguel de Tucuman	Tucuman
Argentina	Hospital del Nino Jesus	San Miguel de Tucuman	Tucuman
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Dawson Clinical Research Inc.	Guelph	Ontario
Canada	Milestone Research , Inc	London	Ontario
Canada	Centre hospitalier universitaire (CHU) Sainte-Justine	Montreal	Quebec
Canada	McGill University Health Centre, Vaccine Study Centre	Pierrefonds	Quebec
Canada	CHU de Quebec-Universite Laval	Québec City	Quebec
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Dr. Hartley Garfield Medicine Professional Corporation	Toronto	Ontario
Chile	CESFAM Colina	Colina, Santiago	Región Metropolitana
Chile	CESFAM Esmeralda	Colina, Santiago	Región Metropolitana
Chile	Biocinetic	Santiago	Región Metropolitana
Chile	Grupo Estudios Clínicos Infectología Respiratoria	Santiago	Región Metropolitana
Chile	Hospital Padre Hurtado	Santiago	Región Metropolitana
Czechia	Ordinace praktickeho lekare pro deti a dorost	Hradec Kralove
Czechia	Ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec II
Czechia	Detska ambulance Petriny spol. s r.o.	Veleslavin
Finland	MeVac - Meilahti Vaccine Research Center	Helsinki
Germany	Kinderarztpraxis Bramsche	Bramsche
Germany	Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel	Herford
Germany	SIBAmed GmbH & Co.KG	Leipzig	Saxony
Germany	Praxis fuer Kinderpneumologie und Allergologie Mannheim	Mannheim
Germany	Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott	Mönchengladbach
Germany	Praxis Dr. med. Joachim Weimer	Reinfeld
Greece	"Aghia Sophia" Children's Hospital	Athens
Greece	P. and A. Kyriakou Children's Hospital	Athens
Greece	University General Hospital "ATTIKON"	Athens
Greece	University General Hospital of Heraklion	Heraklion	Crete
Greece	General University Hospital of Larissa	Larissa	Thessaly
Greece	"Ippokratio" General Hospital of Thessaloniki	Thessaloniki
Hungary	Futurenest Kft. Pestszentimrei Gyermekrendelo	Budapest
Hungary	Gyerkoc Med Bt. Házi Gyermekorvosi Rendelo	Budapest
Hungary	Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis	Csongrad
Hungary	Futurenest Kft. 16. házi gyermekorvosi rendelo	Debrecen
Hungary	Mimiped Bt	Gyor
Hungary	Futurenest Kft	Miskolc
Hungary	Bettimedical BT	Szazhalombatta
Hungary	Papp és Tsa Eü és Szolg Bt	Szigetvar	Baranya
Hungary	Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely	Szombathely	VAS Megye
Puerto Rico	Ponce Medical School Foundation Inc./ CAIMED Center	Ponce
Spain	Clinica Corachan	Barcelona
Spain	Hospital Universitario HM Monteprincipe	Boadilla del Monte	Madrid
Spain	Hospital Universitario de Burgos	Burgos	Castilla Y LEON
Spain	Centro de Salud de Burriana II	Burriana	Castellon
Spain	Centro de Salud L'Eliana	L'Eliana	Valencia
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Grupo Pediatrico Uncibay	Malaga
Spain	Centro de Salud de Paiporta	Paiporta	Valencia
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Valles	Barcelona
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	A Coruna
Spain	Centro de Salud de Malvarrosa	Valencia
Spain	Centro de Salud la Serreria II	Valencia
Spain	FISABIO	Valencia
United States	Idaho Falls Pediatrics	Ammon	Idaho
United States	Elite Clinical Trials LLLP	Blackfoot	Idaho
United States	Boston Medical Center	Boston	Massachusetts
United States	Advantage Clinical Trials	Bronx	New York
United States	PI-Coor Clinical Research LLC	Burke	Virginia
United States	MedClinical Research Partners, LLC	East Orange	New Jersey
United States	Advanced Research for Health Improvement, LLC	Fort Myers	Florida
United States	Ebert Family Clinic	Frisco	Colorado
United States	Good Samaritan Family Health Team	Fullerton	California
United States	Pensacola Pediatrics	Gulf Breeze	Florida
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Idaho Falls Pediatrics	Idaho Falls	Idaho
United States	The Pediatric Center	Idaho Falls	Idaho
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Advent Health Family Medicine Rural Health Clinics, Inc.	Lampasas	Texas
United States	FMC Science	Lampasas	Texas
United States	Tanner Clinic	Layton	Utah
United States	Maximos Ob/Gyn	League City	Texas
United States	All Children Pediatrics	Louisville	Kentucky
United States	Y&L Advance Health Care Inc, d/b/a Elite	Miami	Florida
United States	Advanced Research for Health Improvement, LLC	Naples	Florida
United States	Citadelle Clinical Research	North Miami Beach	Florida
United States	FocilMed	Oxnard	California
United States	Avanza Medical Research Center	Pensacola	Florida
United States	Pensacola Pediatrics	Pensacola	Florida
United States	Rio Grande Valley Clinical Research Institute	Pharr	Texas
United States	Pediatric Partners, PA	Raleigh	North Carolina
United States	Superior Research, LLC	Sacramento	California
United States	Wasatch Pediatrics - St. Marks Office	Salt Lake City	Utah
United States	CopperView Medical Center	South Jordan	Utah
United States	KIDZ Medical Services Pediatric Pulmonary Center	South Miami	Florida
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	Teena Hughes/PAS Research	Tampa	Florida
United States	Cotton O'Neil Clinical Research Center, Pediatrics	Topeka	Kansas
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Carey Chronis, MD	Ventura	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Fomat - Robert Nudelman MD	Westlake Village	California
United States	Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)	Winston-Salem	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Czechia,  Finland,  Germany,  Greece,  Hungary,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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