Phase 3
N=400
Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT02225587 ↗Enrolled (actual)
400
Serious AEs
5.0%
Results posted
Feb 2020
Primary outcome: Primary: Percentage of Participants With an Adverse Event (AE) — 89.9; 84.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Prevnar 13™ (Biological); Pneumovax™ 23 (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) |
89.9; 84.4 | — |
| PRIMARY Percentage of Participants With an Injection-site Adverse Event |
86.4; 77.9 | — |
| PRIMARY Percentage of Participants With a Systemic Adverse Event |
76.8; 74.4 | — |
| PRIMARY Percentage of Participants With a Serious Adverse Event (SAE) |
4.5; 5.5 | — |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death |
0; 0 | — |
| PRIMARY Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event |
2.5; 2.5 | — |
| PRIMARY Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 |
1766.3; 39.0; 10413.0; 1189.9 | — |
| PRIMARY Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 |
81.7; 57.1; 43.4; 17.5; 1079.3; 780.0 | — |
| SECONDARY Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8 |
100.7; 54.7; 52.8; 27.8; 1075.7; 1051.0 | — |
| SECONDARY Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26 |
39.7; 18.9; 19.6; 9.2; 737.1; 788.4 | — |
| SECONDARY Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30 |
36.0; 43.4; 13.9; 32.8; 803.6; 1060.0 | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of sequential administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.
Eligibility Criteria
Inclusion Criteria
- Any chronic illness must be documented to be in stable condition
- Male, or a female agrees to remain abstinent, or use, or have their partner use, 2 acceptable methods of contraception through 6 weeks after receiving study vaccination; or a female who is not of reproductive potential
Exclusion Criteria
- Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
- Prior administration of any pneumococcal vaccine
- History of invasive pneumococcal disease
- Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function, documented Human Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease
- Received systemic corticosteroids (equivalent of >=2 mg/kg total daily dose of prednisone or >=20 mg/kg for persons weighing >10 kg) for >=14 consecutive days and has not completed treatment <=30 days before study vaccination, or has received systemic corticosteroids exceeding physiological doses (~5 mg/day prednisone equivalent) within 14 days before study vaccination (topical, ophthalmic, intra-articular, and inhaled/nebulized steroids are permitted).
- Has a coagulation disorder contraindicating intramuscular vaccination
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease
- Received a blood transfusion or blood products, including immunoglobulins <=6 months before receiving study vaccine, or is scheduled to receive them within 30 days
- Participated in another clinical study of an investigational product <=2 months before or during the current study
- Is breast-feeding
Data sourced from ClinicalTrials.gov (NCT02225587). 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.