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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

Treatments: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427895

6115A1-004

B1851019

Details and patient eligibility

About

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.

Enrollment: 2,141 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
• Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
• Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Exclusion criteria

• Previous immunization with any licensed or experimental pneumococcal vaccine.
• Serious chronic disorders 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 which in the investigator's opinion precludes the subject from participating in the study.
• Known or suspected impairment of immunological function.

Trial design

2,141 participants in 7 patient groups

13vPnC Cohort 1, Vaccination 1

Experimental group

Description:

Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

23vPS Cohort 1, Vaccination 1

Active Comparator group

Description:

Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.

Treatment:

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

13vPnC Cohort 2, Vaccination 1

Experimental group

Description:

Participants aged 50-59 years given a 0.5 mL dose administered on day 1.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

13vPnC Cohort 3, Vaccination 1

Experimental group

Description:

Participants aged 18-49 years given a 0.5 mL dose administered on day 1.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

13vPnC Cohort 1, Vaccination 2

Experimental group

Description:

Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

23vPS Cohort 1, Vaccination 2

Active Comparator group

Description:

Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1.

Treatment:

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)

13vPnC Cohort 2, Vaccination 2

Experimental group

Description:

Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)