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Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

NCT00427895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2141

Last updated 2021-11-15

Study results available
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Summary

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

0.5 mL dose administered on day 1

BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered on day 1

BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered 3-4 years after dose 1

BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

0.5 mL dose administered 3-4 years after dose 1

BIOLOGICAL

13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL dose administered 3-4 years after dose 1

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE

Eligibility

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

Timeline & Regulatory

Start
2007-02-27
Primary Completion
2011-08-01
Completion
2011-08-01

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 NCT00427895 on ClinicalTrials.gov