NCT00427895

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

A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,141 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-02-27
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2007-01-29
• Last updated: 2021-11-15
• Results posted: 2012-09-05

Locations

26 sites across 1 country: United States