Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: 20vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04642079

2019-003308-11 (EudraCT Number)

B7471014

Details and patient eligibility

About

This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age

Enrollment: 839 patients

Sex: All

Ages: 15 months to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female children ≥15 months to <18 years of age at the time of consent.
• Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
• For children <5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment into the study

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
• Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
• Cohorts 3 and 4: Pregnant or breastfeeding female participants

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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839 participants in 4 patient groups

Cohort 1: =>15 through 23 months of age

Experimental group

Description:

20vPnC

Treatment:

Biological: 20vPnC

Cohort 2: 2 through 4 years of age

Experimental group

Description:

20vPnC

Treatment:

Biological: 20vPnC

Cohort 3: 5 through 9 years of age

Experimental group

Description:

20vPnC

Treatment:

Biological: 20vPnC

Cohort 4: 10 through 17 years of age

Experimental group

Description:

20vPnC

Treatment:

Biological: 20vPnC