Clinical trial NCT02225587: 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)
Official title: Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Subjects 50 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-08-26
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: Up to 14 days after any vaccination (Up to 28 weeks)
measure: Percentage of Participants With an Injection-site Adverse Event
timeFrame: Up to 14 days after any vaccination (Up to 28 weeks)
measure: Percentage of Participants With a Systemic Adverse Event
timeFrame: Up to 14 days after any vaccination (Up to 28 weeks)
measure: Percentage of Participants With a Serious Adverse Event (SAE)
timeFrame: Up to 30 weeks
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death
timeFrame: Up to 30 weeks
measure: Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event
timeFrame: Up to 26 weeks
measure: Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12
timeFrame: Week 12
measure: Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Week 8
measure: 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
timeFrame: Week 26
measure: 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
timeFrame: Week 30
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Buchwald UK, Andrews CP, Ervin J, Peterson JT, Tamms GM, Krupa D, Ajiboye P, Roalfe L, Krick AL, Sterling TM, Wang M, Martin JC, Stek JE, Kohn MA, Folaranmi T, Abeygunawardana C, Hartzel J, Musey LK; V110-029 Study Group. Sequential administration of Prevnar 13 and PNEUMOVAX 23 in healthy participants 50 years of age and older. Hum Vaccin Immunother. 2021 Aug 3;17(8):2678-2690. doi: 10.1080/21645515.2021.1888621. Epub 2021 May 21.