Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

Pneumococcal Disease Clinical Trial

Official title:

A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408429
• Other study ID #: B7471027
• Secondary ID: 2021-006624-41
• Status: Completed
• Phase: Phase 3
• Start date: June 24, 2022
• Est. completion date: June 1, 2023

Study information

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

Clinical Trial Summary

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.

This study is being conducted in children who:

• are between 12 to 23 months of age;

• are healthy as determined by the study doctors;

• have received 2 doses of Prevnar 13 during the first year in life.

Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• Male or female toddlers =12 to <24 months of age at the time of consent

• Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study

• 2 infant doses of Prevenar 13 prior to 12 months of age

Exclusion Criteria:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)

• Major known congenital malformation or serious chronic disorder

• Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.

• Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

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

Locations

Country	Name	City	State
Hungary	Elitance Duo Kft.	Budapest
Hungary	Gyerkoc- Med Szolgáltató és Kereskedelmi Betéti Társaság	Budapest
Hungary	Lurko-Med Kft Hazi Gyermekorvosi Rendelo	Budapest
Hungary	Private practice - Dr. Várhelyiné Dr. Torday Judit	Debrecen
Hungary	Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet	Eger
Hungary	Mimiped Betéti Társaság	Gyor
Hungary	Futurenest Klinikai Kutató Kft.	Miskolc
Hungary	Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság	Szigetvár
Poland	IN-VIVO Bydgoszcz	Bydgoszcz
Poland	SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym	Dziekanów Lesny
Poland	NZOZ Vita Longa Sp. z o.o.	Katowice
Poland	Pro Familia Altera Sp. z o.o.	Katowice
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow
Poland	Przyladek Zdrowia	Krakow	Malopolskie
Poland	Przyladek Zdrowia	Krakow
Poland	SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym	Lomianki	Mazowieckie
Poland	Rodzinne Centrum Medyczne LUBMED	Lubon	Wielkopolskie
Poland	Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu	Poznan
Poland	Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu	Poznan
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
Poland	MICS Centrum Medyczne Torun	Torun
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Poland	Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona [barcelona]
Spain	Hospital de Nens de Barcelona	Barcelona
Spain	Hospital Universitario HM Monteprincipe	Boadilla del Monte	Madrid
Spain	EAP Osona Sud - Alt Congost S.L.P	Centelles	Catalunya [cataluña]
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona [barcelona]
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Puerta del Sur	Madrid	Madrid, Comunidad DE
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Grupo Pediatrico Uncibay	Malaga
Spain	Grupo Pediatrico Uncibay	Malaga	Málaga
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Vallès	Barcelona
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	A Coruña [LA Coruña]
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	LA Coruña
Spain	Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela	LA Coruña
Spain	Instituto Hispalense de Pediatria	Sevilla
Spain	Instituto Hispalense de Pediatria	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting prompted local reactions within 7 days after the last assigned vaccination in each group	Prompted local reactions after the last assigned vaccination in each group	Day 7
Primary	Percentage of participants reporting prompted systemic events within 7 days after the last assigned vaccination in each group	Prompted systemic events after the last assigned vaccination in each group	Day 7
Primary	Percentage of participants reporting adverse events (AEs) within 1 month after the last assigned vaccination in each group	AEs occurring from last vaccination to 1 month after the last vaccination in each group	1 month after the last vaccination
Primary	Percentage of participants reporting serious adverse events (SAEs) within month after the last assigned vaccination in each group	SAEs occurring from last vaccination to 1 month after the last vaccination in each group	1 month after the last vaccination
Primary	Percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes 1 month after the last assigned vaccination in each group	IgG concentrations 1 month after the last assigned vaccination	1 month after the last vaccination
Secondary	Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after the last assigned vaccination in each group	IgG GMCs 1 month after the last assigned vaccination	1 month after the last vaccination
Secondary	Percentages of participants with predefined serotype-specific IgG concentrations for the 13 matched serotypes 1 month after the last assigned vaccination in each group	IgG concentrations 1 month after the last assigned vaccination	1 month after the last vaccination
Secondary	Opsonophagocytic activity (OPA) GMTs 1 month after the last assigned vaccination in each in group	OPA GMTs 1 month after the last assigned vaccination	1 month after the last vaccination

External Links

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