MedTrace Logo

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

NCT03313037 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2019-12-26

Study results available
· View outcomes & findings →

Summary

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).

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Multivalent

Pneumococcal conjugate vaccine

BIOLOGICAL

Prevnar 13

Pneumococcal conjugate vaccine

BIOLOGICAL

PPSV23

Pneumococcal polysaccharide vaccine

OTHER

Saline

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2018-12-10
Completion
2018-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313037 on ClinicalTrials.gov