Safety and Immunogenicity of V116 in Adults 50 Years of Age or Older

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

17 Nov 2022 → 30 Jan 2025

Decision date (initial)

2023-07-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2022-503144-40-00

EudraCT number

2022-001785-35

WHO UTN

U1111-1286-5378

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Safety, Others

1.To evaluate the safety and tolerability of V116 as assessed by the proportion of participants with adverse events (AEs)
2.To compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PPSV23
3.To compare the proportions of participants with a ≥4-fold rise in serotype-specific OPA responses from baseline to 30 days postvaccination with V116 versus PPSV23 for the unique serotypes in V116.

Secondary objectives 3

1. To evaluate serotype-specific cross-reactive OPA responses from baseline to 30 days postvaccination with V116 for serotypes within a serogroup.
2. To evaluate the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days postvaccination with V116 compared with PPSV23.
3. To evaluate the serotype-specific geometric mean fold rise (GMFR) and proportions of participants with a ≥4-fold rise in serotype-specific OPA and IgG responses from baseline to 30 days postvaccination with V116 and separately for PPSV23

Conditions and MedDRA coding

Pneumococcal disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy

Exclusion criteria 12

1. Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
2. Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
3. Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
4. Has a coagulation disorder contraindicating IM vaccination
5. Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
6. Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
7. Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
8. Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
9. Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
10. Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
11. Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
12. Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Percentage of participants with solicited injection-site AEs
2. Percentage of participants with solicited systemic AEs
3. Percentage of participants with vaccine-related serious AE (SAE)
4. Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs)
5. Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs (unique to V116)

Secondary endpoints 6

1. Percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs
2. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
3. Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs
4. Serotype-specific GMFR in IgG GMCs
5. Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes)
6. Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Veronika Jotterand

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Veronika Jotterand

Third parties 6

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications