Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Other: Saline; Biological: PPSV23; Biological: Multivalent; Biological: Prevnar 13

Study type: Interventional

Funder types: Industry

Identifiers

NCT03313037

B7471002

Details and patient eligibility

About

This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).

Enrollment: 444 patients

Sex: All

Ages: 60 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
2. Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
3. Female subjects who are not 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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444 participants in 2 patient groups

Multivalent

Experimental group

Description:

Pneumococcal conjugate vaccine

Treatment:

Other: Saline

Biological: Multivalent

Control

Active Comparator group

Description:

Prevnar 13 and PPSV23

Treatment:

Biological: Prevnar 13

Biological: PPSV23