20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04379713

B7471013

2019-003307-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,511 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,511 participants in 2 patient groups

20-valent pneumococcal conjugate vaccine

Experimental group

Description:

Pneumococcal conjugate vaccine

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Active Comparator group

Description:

Pneumococcal conjugate vaccine

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine