Phase 2
N=444
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT03313037 ↗Enrolled (actual)
444
Serious AEs
4.5%
Results posted
Dec 2019
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 — 7.3; 3.6; 3.6; 3.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Multivalent (Biological); Prevnar 13 (Biological); PPSV23 (Biological); Saline (Other)
- Age
- Adult · 60+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 |
7.3; 3.6; 3.6; 3.2; 0.5; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 |
0; 0.5; 0; 0.5; 0; 0 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 |
12.2; 13.1 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 |
5.4; 4.5 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 |
10.0; 6.3 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC |
302; 454; 51; 64; 876; 1153 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC |
740; 1150; 2604; 988; 3210; 3007 | — |
| SECONDARY Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC |
21.2; 33.5; 6.0; 7.1; 37.8; 51.0 | — |
| SECONDARY Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC |
37.1; 56.9; 49.3; 17.1; 11.2; 9.8 | — |
Summary
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).
Eligibility Criteria
Inclusion Criteria
- Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
- Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
- Female subjects who are not of childbearing potential.
Exclusion Criteria
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Serious chronic disorder 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 that, in the investigator's opinion, excludes the subject from participating in the study.
Data sourced from ClinicalTrials.gov (NCT03313037). 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.