Phase 3
N=2,068
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00427895 ↗Enrolled (actual)
2,068
Serious AEs
0.8%
Results posted
Sep 2012
Primary outcome: Primary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1 — 146; 104; 200; 353 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (13vPnC) (Biological); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1 |
146; 104; 200; 353; 93; 85 | — |
| PRIMARY Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1 |
88.5; 49.3 | — |
| PRIMARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group |
398; 116; 95; 164; 105; 53 | — |
| SECONDARY Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1 |
90.3; 83.8; 94.0; 97.6; 92.1; 88.3 | — |
| SECONDARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2 |
72.6; 69.7; 15.6; 54.0; 13.2; 21.2 | — |
| SECONDARY Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination |
9.53; 4.13; 4.36; 6.92; 2.58; 1.88 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00427895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.