Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: 20vPnC; Other: Saline; Biological: PPSV23; Biological: 13vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03760146

B7471007

2018-004279-11 (EudraCT Number)

Details and patient eligibility

About

A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Enrollment: 3,902 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

Exclusion criteria

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
2. History of microbiologically proven invasive disease caused by S pneumoniae.
3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
4. Pregnant female subjects or breastfeeding female subjects.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,902 participants in 6 patient groups

60 years and above 20vPnC/Saline

Experimental group

Description:

20vPnC and saline

Treatment:

Biological: 20vPnC

Other: Saline

60 years and above 13vPnC/PPSV23

Active Comparator group

Description:

13vPnC and PPSV23

Treatment:

Biological: PPSV23

Biological: 13vPnC

50 through 59 years of age 20vPnC

Experimental group

Description:

20vPnC

Treatment:

Biological: 20vPnC

18 through 49 years of age 20vPnC

Experimental group

Description:

20vPnC

Treatment:

Biological: 20vPnC

50 through 59 years of age 13vPnC

Active Comparator group

Description:

13vPnC

Treatment:

Biological: 13vPnC

18 through 49 years of age 13vPnC

Active Comparator group

Description:

13vPnC

Treatment:

Biological: 13vPnC