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)

NCT ID: NCT02225587

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-28
• Study Completion Date: 2015-07-06

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.

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo

Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.

Group Type: EXPERIMENTAL

Prevnar 13™

Intervention Type: BIOLOGICAL

Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.

Pneumovax™ 23

Intervention Type: BIOLOGICAL

Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.

Placebo

Intervention Type: BIOLOGICAL

Injections are to be administered into the deltoid muscle of the upper arm.

Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23

Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.

Group Type: PLACEBO_COMPARATOR

Prevnar 13™

Intervention Type: BIOLOGICAL

Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.

Pneumovax™ 23

Intervention Type: BIOLOGICAL

Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.

Placebo

Intervention Type: BIOLOGICAL

Injections are to be administered into the deltoid muscle of the upper arm.

Interventions

Prevnar 13™

Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.

Intervention Type: BIOLOGICAL

Pneumovax™ 23

Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.

Intervention Type: BIOLOGICAL

Placebo

Injections are to be administered into the deltoid muscle of the upper arm.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34019468 (View on PubMed)

Other Identifiers

2013-003027-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V110-029

Identifier Type: OTHER

Identifier Source: secondary_id

V110-029

Identifier Type: -

Identifier Source: org_study_id