Phase 3
N=324
13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01432262 ↗Enrolled (actual)
324
Serious AEs
0.6%
Results posted
Jan 2013
Primary outcome: Primary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination — 120; 84; 88; 89 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- vaccine-13vPnC (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination |
120; 84; 88; 89; 1729; 1209 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination |
14.4; 15.8; 9.7; 13.3; 8.8; 7.0 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination |
2.4; 10.2; 1.6; 3.5; 0.8; 1.8 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
11.1; 6.2; 0.0; 1.2 | — |
| SECONDARY Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination |
90.3; 81.0; 94.8; 90.1; 97.4; 98.7 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination |
21.3; 11.7; 12.5; 7.8; 57.7; 19.9 | — |
Summary
The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.
Eligibility Criteria
Inclusion Criteria
- Male or female older than 50 years of age
- Eligibility must be determined by medical history, physical exam and clinical judgment
- Able to complete an electronic diary
- Available for duration of study
- Negative pregnancy test for subjects in group 2 age 50 to 64 years
- Practice abstinence or use reliable birth control if age is 50 to 64 years
Exclusion Criteria
- History of allergic reaction to any vaccine
- Previous vaccination with licensed or experimental pneumococcal vaccine
- S. pneumonia infection within past 5 years before investigational product administration
- Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
- Receipt of plasma products or immunoglobulins within 60 days
- Bleeding conditions or diathesis
- Receipt of investigational product within 28 days before study entry
- Other severe acute or chronic medical or psychiatric condition
Data sourced from ClinicalTrials.gov (NCT01432262). 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.