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A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

NCT01646398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 764

Last updated 2013-09-20

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

Conditions

  • Pneumococcal Vaccines
  • Pneumococcal Conjugate Vaccine

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Japan

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 NCT01646398 on ClinicalTrials.gov