Phase 2
N=66
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT03313050 ↗Enrolled (actual)
66
Serious AEs
3.7%
Results posted
Jun 2020
Primary outcome: Primary: Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination — 2.9; 12.5; 2.9; 6.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Multivalent (Biological); Tdap (Biological); polysaccharide (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination |
2.9; 12.5; 2.9; 6.3; 0; 6.3 | — |
| PRIMARY Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination |
8.1; 17.9; 5.9; 8.1; 2.3; 4.5 | — |
| PRIMARY Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination |
0.5; 0.9; 0.5; 0; 0; 0.4 | — |
| PRIMARY Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination |
8.8; 9.4 | — |
| PRIMARY Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination |
10.0; 13.5 | — |
| PRIMARY Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination |
5.9; 0 | — |
| PRIMARY Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination |
2.3; 2.7 | — |
| PRIMARY Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination |
0; 6.3 | — |
| PRIMARY Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination |
3.2; 4.5 | — |
| PRIMARY Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination |
4.1; 3.6 | — |
| PRIMARY Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination |
6.8; 6.3 | — |
| SECONDARY Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination |
1401; 16; 6622; 92; 3154; 604 | — |
| SECONDARY Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination |
528; 639; 2297; 1052; 2290; 2673 | — |
| SECONDARY Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination |
106.2; 1.1; 64.7; 1.2; 6.5; 1.0 | — |
| SECONDARY Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination |
30.2; 40.5; 30.6; 15.2; 7.5; 7.0 | — |
Summary
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.
In Stage 1 healthy adults 50 to 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 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).
In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
Eligibility Criteria
Inclusion Criteria
- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration
Exclusion Criteria
- Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
Data sourced from ClinicalTrials.gov (NCT03313050). 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.