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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04546425




Registration number
NCT04546425
Ethics application status
Date submitted
21/08/2020
Date registered
14/09/2020

Titles & IDs
Public title
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS
Secondary ID [1] 0 0
2019-003306-27
Secondary ID [2] 0 0
B7471012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 20-valent pneumococcal conjugate vaccine
Treatment: Other - 13-valent pneumococcal conjugate vaccine

Experimental: 20-valent pneumococcal conjugate vaccine - Pneumococcal conjugate vaccine

Active comparator: 13-valent pneumococcal conjugate vaccine - Pneumococcal conjugate vaccine


Treatment: Other: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine

Treatment: Other: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Timepoint [1] 0 0
Within 7 days after Dose 1
Primary outcome [2] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Timepoint [2] 0 0
Within 7 days after Dose 2
Primary outcome [3] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Timepoint [3] 0 0
Within 7 days after Dose 3
Primary outcome [4] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Timepoint [4] 0 0
Within 7 Days after Dose 1
Primary outcome [5] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Timepoint [5] 0 0
Within 7 Days after Dose 2
Primary outcome [6] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Timepoint [6] 0 0
Within 7 Days after Dose 3
Primary outcome [7] 0 0
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population
Timepoint [7] 0 0
From Dose 1 to 1 month after Dose 2
Primary outcome [8] 0 0
Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population
Timepoint [8] 0 0
From Dose 3 to 1 month after Dose 3
Primary outcome [9] 0 0
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population
Timepoint [9] 0 0
From Dose 1 to 1 month after Dose 3
Primary outcome [10] 0 0
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population
Timepoint [10] 0 0
From Dose 1 to 1 month after Dose 3
Primary outcome [11] 0 0
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Timepoint [11] 0 0
1 month after Dose 2
Primary outcome [12] 0 0
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Timepoint [12] 0 0
1 month after Dose 2
Primary outcome [13] 0 0
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Timepoint [13] 0 0
1 month after Dose 3
Primary outcome [14] 0 0
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Timepoint [14] 0 0
1 month after Dose 3
Primary outcome [15] 0 0
GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population
Timepoint [15] 0 0
1 month after Dose 3
Primary outcome [16] 0 0
GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population
Timepoint [16] 0 0
1 month after Dose 3
Primary outcome [17] 0 0
GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population
Timepoint [17] 0 0
1 month after Dose 3
Primary outcome [18] 0 0
GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population
Timepoint [18] 0 0
1 month after Dose 3
Primary outcome [19] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Timepoint [19] 0 0
Within 7 days after Dose 1
Primary outcome [20] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Timepoint [20] 0 0
Within 7 days after Dose 2
Primary outcome [21] 0 0
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Timepoint [21] 0 0
Within 7 days after Dose 3
Primary outcome [22] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Timepoint [22] 0 0
Within 7 Days after Dose 1
Primary outcome [23] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Timepoint [23] 0 0
Within 7 Days after Dose 2
Primary outcome [24] 0 0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Timepoint [24] 0 0
Within 7 Days after Dose 3
Primary outcome [25] 0 0
Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort
Timepoint [25] 0 0
From Dose 1 to 1 month after Dose 2
Primary outcome [26] 0 0
Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort
Timepoint [26] 0 0
From Dose 3 to 1 month after Dose 3
Primary outcome [27] 0 0
Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort
Timepoint [27] 0 0
From Dose 1 to 1 month after Dose 3
Primary outcome [28] 0 0
Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort
Timepoint [28] 0 0
From Dose 1 to 1 month after Dose 3
Primary outcome [29] 0 0
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Timepoint [29] 0 0
1 month after Dose 2
Primary outcome [30] 0 0
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Timepoint [30] 0 0
1 month after Dose 2
Primary outcome [31] 0 0
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Timepoint [31] 0 0
1 month after Dose 3
Secondary outcome [1] 0 0
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Timepoint [1] 0 0
1 Month after Dose 3
Secondary outcome [2] 0 0
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
Timepoint [2] 0 0
1 month after Dose 2
Secondary outcome [3] 0 0
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
Timepoint [3] 0 0
1 Month after Dose 3
Secondary outcome [4] 0 0
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
Timepoint [4] 0 0
Before Dose 3 to 1 month after Dose 3
Secondary outcome [5] 0 0
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Timepoint [5] 0 0
1 month after Dose 2
Secondary outcome [6] 0 0
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Timepoint [6] 0 0
1 Month after Dose 3
Secondary outcome [7] 0 0
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
Timepoint [7] 0 0
1 month after Dose 2
Secondary outcome [8] 0 0
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
Timepoint [8] 0 0
1 Month after Dose 3

Eligibility
Key inclusion criteria
* Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Minimum age
42 Days
Maximum age
112 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2023
Sample size
Target
Accrual to date
Final
1258
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 0 0
Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Czechia
State/province [3] 0 0
Jindrichuv Hradec
Country [4] 0 0
Czechia
State/province [4] 0 0
Pardubice
Country [5] 0 0
Czechia
State/province [5] 0 0
Praha 3
Country [6] 0 0
Czechia
State/province [6] 0 0
Praha 6
Country [7] 0 0
Denmark
State/province [7] 0 0
Hvidovre
Country [8] 0 0
Estonia
State/province [8] 0 0
Kadrina
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Estonia
State/province [10] 0 0
Tartu
Country [11] 0 0
Finland
State/province [11] 0 0
Espoo
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
Finland
State/province [13] 0 0
Jarvenpaa
Country [14] 0 0
Finland
State/province [14] 0 0
Kokkola
Country [15] 0 0
Finland
State/province [15] 0 0
Oulu
Country [16] 0 0
Finland
State/province [16] 0 0
Pori
Country [17] 0 0
Finland
State/province [17] 0 0
Seinajoki
Country [18] 0 0
Finland
State/province [18] 0 0
Tampere
Country [19] 0 0
Finland
State/province [19] 0 0
Turku
Country [20] 0 0
Italy
State/province [20] 0 0
Milan
Country [21] 0 0
Italy
State/province [21] 0 0
Firenze
Country [22] 0 0
Italy
State/province [22] 0 0
Foggia
Country [23] 0 0
Italy
State/province [23] 0 0
Genova
Country [24] 0 0
Netherlands
State/province [24] 0 0
Haarlem
Country [25] 0 0
Netherlands
State/province [25] 0 0
Hoofddorp
Country [26] 0 0
Norway
State/province [26] 0 0
Lorenskog
Country [27] 0 0
Norway
State/province [27] 0 0
Oslo
Country [28] 0 0
Norway
State/province [28] 0 0
Stavanger
Country [29] 0 0
Norway
State/province [29] 0 0
Viken
Country [30] 0 0
Poland
State/province [30] 0 0
Bydgoszcz
Country [31] 0 0
Poland
State/province [31] 0 0
Debica
Country [32] 0 0
Poland
State/province [32] 0 0
Krakow
Country [33] 0 0
Poland
State/province [33] 0 0
Leczna
Country [34] 0 0
Poland
State/province [34] 0 0
Lodz
Country [35] 0 0
Poland
State/province [35] 0 0
Lubon
Country [36] 0 0
Poland
State/province [36] 0 0
Poznan
Country [37] 0 0
Poland
State/province [37] 0 0
Siemianowice Slaskie
Country [38] 0 0
Poland
State/province [38] 0 0
Torun
Country [39] 0 0
Poland
State/province [39] 0 0
Trzebnica
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Poland
State/province [41] 0 0
Wroclaw
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Ekaterinburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Perm
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Saint Petersburg
Country [46] 0 0
Slovakia
State/province [46] 0 0
Bratislava
Country [47] 0 0
Slovakia
State/province [47] 0 0
Detva
Country [48] 0 0
Slovakia
State/province [48] 0 0
Horne Srnie
Country [49] 0 0
Slovakia
State/province [49] 0 0
Humenne
Country [50] 0 0
Slovakia
State/province [50] 0 0
Kosice
Country [51] 0 0
Slovakia
State/province [51] 0 0
Liptovská Osada

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04546425