Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
820
Countries
5
Sites
27
Pneumococcal disease
1. To evaluate the safety and tolerability of V116 with respect to the proportion of participants with adverse events (AEs) 2. To compare the serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PPSV23.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 25 Mar 2024 → 6 Mar 2025
- Decision date (initial)
- 2024-03-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-506236-32-00
- WHO UTN
- U1111-1293-4944
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Others, Safety
1. To evaluate the safety and tolerability of V116 with respect to the proportion of participants with adverse events (AEs)
2. To compare the serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PPSV23.
Secondary objectives 2
- To evaluate the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days postvaccination with V116 compared with PPSV23.
- To evaluate the serotype-specific geometric mean fold rises (GMFRs) and proportions of participants with a ≥4-fold rise in serotype-specific OPA responses and IgG responses from baseline to 30 days postvaccination within each vaccination group.
Conditions and MedDRA coding
Pneumococcal disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061353 | Pneumococcal infection | 100000004862 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003155-PIP01-21
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Has one or more of the following risk conditions for pneumococcal disease: • Diabetes mellitus receiving treatment with antidiabetic medication • Chronic compensated liver disease • Chronic lung disease • Chronic heart disease • Chronic kidney disease, with chronic kidney insufficiency/impairment
- Receiving stable medical management for the risk conditions listed above for ≥3 months.
- Has not received pneumococcal vaccine, polyvalent (23-valent) (PPSV23) or has received not more than 1 dose of PPSV23 ≥5 years before study vaccination.
Exclusion criteria 6
- Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
- History of active hepatitis within 3 months before study vaccination
- History of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination
- History of severely decreased kidney function
- History of severe pulmonary hypertension
- History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within 3 years before study vaccination
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Percentage of participants with solicited injection-site adverse events (AEs)
- Percentage of participants with solicited systemic AEs
- Percentage of participants with vaccine-related serious adverse events (SAEs)
- Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) following vaccination
Secondary endpoints 5
- Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination
- Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs
- Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs
- GMFR from baseline in serotype-specific IgG GMCs
- 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
Pneumococcal 21-valent Conjugate Vaccine
PRD10038509 · Product
- Active substance
- Pneumococcal Polysaccharide Serotype 33F Conjugated to CRM197
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
Pneumovax® 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine
PRD8737967 · Product
- Active substance
- Pneumococcal Polysaccharide Serotype 4
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
- Marketing authorisation
- PL 53095/0005
- MA holder
- MERCK SHARP & DOHME (UK) LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10950925 · Product
- Active substance
- Pneumococcal Polysaccharide Serotype 4
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
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
- Jayani Pathirana
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jayani Pathirana
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Fortrea Inc. ORG-100012602
|
Princeton, United States | Other |
Locations
5 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 60 | 7 |
| France | Ended | 25 | 3 |
| Poland | Ended | 40 | 6 |
| Spain | Ended | 60 | 8 |
| Sweden | Ended | 30 | 3 |
| Rest of world
Thailand, Chile, Canada, Colombia, Japan, Turkey, Israel, United States
|
— | 605 | — |
Investigational sites
FVR Suomen rokotetutkimus Oy
FVR, Turku Clinic, Lemminkaisenkatu 14-18 B, 20520, Turku
FVR Suomen rokotetutkimus Oy
FVR, Kokkola Clinic, Rantakatu 16, 67100, Kokkola
FVR Suomen rokotetutkimus Oy
FVR, Oulu Clinic, Kiviharjunlenkki 6, 90220, Oulu
HUS-yhtymae
MeVac-Meilahti Vaccine Research Center, Haartmaninkatu 8, 00290, Helsinki
FVR Suomen rokotetutkimus Oy
FVR, Tampere Clinic, Pinninkatu 47 1 Krs, 33100, Tampere
FVR Suomen rokotetutkimus Oy
FVR, Seinäjoki Clinic, Kauppatori 1-3, 60100, Seinajoki
FVR Suomen rokotetutkimus Oy
FVR, Espoo Clinic, Piispansilta 11, 02230, Espoo
Centre Hospitalier Universitaire De Lille
Infectiologie pédiatrique, Avenue Eugene Avinee, 59037, Lille Cedex
Robert Debre University Hospital
Pédiatrie, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire De Caen Normandie
Néonatalogie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
In Vivo Sp. z o.o.
NA, Ul. Kaszubska 17h, 85-048, Bydgoszcz
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Pediatrii i Chorób Infekcyjnych, Ul Tytusa Chalubinskiego 2-2a, 50-368, Wroclaw
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej Im. Dzieci Warszawy W Dziekanowie Lesnym
Pediatria, Ul. Marii Konopnickiej 65, Dziekanow Lesny, Lomianki
Gravita Diagnostyka I Leczenie Nieplodnosci
NA, Ul. Gen. Karola Kniaziewicza 20a, 91-347, Lodz
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Centrum Szczepien, Ul. Pradnicka 80, 31-202, Cracow
Pratia S.A.
NA, Ul. Wojciecha Lochowskiego 7a, 85-796, Bydgoszcz
Hospital Universitario Severo Ochoa
Pediatría, Avenida Orellana S/n, 28911, Leganes
Sant Joan De Deu Barcelona Hospital
Infecciosas-pediatria, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Germans Trias I Pujol
Pediatría, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario La Paz
Consultas de pediatría, enfermedades infecciosas y tropicales, Paseo Castellana 261, 28046, Madrid
University Hospital Virgen Del Rocio S.L.
Infecciosas-pediatria, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
Pediatria, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario 12 De Octubre
Unidad Pediátrica de Investigación Clínica, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Pediatría, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-03-28 | 2025-02-18 | 2024-04-10 | 2024-08-31 | |
| France | 2024-04-02 | 2025-02-18 | 2024-05-15 | 2024-08-30 | |
| Poland | 2024-04-12 | 2025-02-25 | 2024-04-29 | 2024-08-31 | |
| Spain | 2024-03-25 | 2025-02-12 | 2024-04-02 | 2024-08-31 | |
| Sweden | 2024-04-12 | 2025-02-04 | 2024-06-28 | 2024-08-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-94407
|
2025-08-14T13:08:10 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results Plain Language Summary | 2025-08-08T11:39:35 | Submitted | Laypersons Summary of Results |
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_ESP_ES_for pub | 16JUL2025 |
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_FIN_FI_for pub | 16JUL2025 |
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_FIN_SV_for pub | 16JUL2025 |
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_for pub | 16JUL2025 |
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_FRA_FR_for pub | 16JUL2025 |
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_POL_PL_for pub | 16JUL2025 |
| Laypersons summary of results (for publication) | RPLS_2023-506236-32_SWE_SV_for pub | 16JUL2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ESP_ES_for pub | 27OCT2023R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_POL_PL_for pub | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_ESP_ES_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Leave Behind Flyer_ESP_ES_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR adult consent_ESP_ES_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR assent_ESP_ES_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR assent_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR parent consent_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main adult consent_ESP_ES_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main assent 02-05 yr_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main assent 06-09 yr_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main assent 10-12 yr_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main assent 12-17 yr_ESP_ES_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main assent 13-17 yr_POL_PL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main parent_POL_PL_for pub | 00R |
| Summary of results (for publication) | Summary of Results_2023-506236-32_for pub | 12Aug2025 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | Spain | Acceptable 2024-03-18
|
2024-03-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-21 | Acceptable 2024-03-18
|
2024-03-21 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-22 | Acceptable | 2024-05-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-26 | Spain | Acceptable | 2024-05-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-27 | Acceptable | 2024-07-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-14 | Acceptable | 2024-07-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-24 | Spain | Acceptable | 2024-08-21 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-22 | Spain | Acceptable | 2025-01-22 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-25 | Acceptable | 2025-02-25 |