20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series 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

NCT04382326

2019-003305-10 (EudraCT Number)

B7471011

Details and patient eligibility

About

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Enrollment: 1,997 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

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.

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 receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,997 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