Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC); Other: Saline; Biological: Influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04526574

B7471004

Details and patient eligibility

About

Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately

Enrollment: 1,796 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female participants ≥65 years of age at the time of consent
• Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
• Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.

Exclusion criteria

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)

• Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.

• Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.

  -- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,796 participants in 2 patient groups

Coadministration Group

Active Comparator group

Description:

Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.

Treatment:

Biological: Influenza vaccine

Other: Saline

Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)

Separate Administration Group

Active Comparator group

Description:

Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.

Treatment:

Biological: Influenza vaccine

Other: Saline

Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)