Pneumococcal InfectionsPhase 3NCT03731182
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
A Phase 3 study testing V114 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 19 sites in 7 countries.
Trial summary
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- V114 and Prevnar 13™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 23 Jan 2019to 8 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documented diagnosis of sickle cell disease in their medical record
- Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
- 1) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.
Who cannot join
- History of Invasive Pneumococcal Disease (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)
- Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency
- Documented human immunodeficiency virus (HIV) infection
- History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus)
Show all 18Show fewer
- Known coagulation disorder contraindicating intramuscular vaccination
- History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1)
- Received any PCV or pneumococcal polysaccharide vaccine <3 years before Visit 1 (Day 1)
- Five (5) years of age and has received <3 doses of PCV
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Note: hydroxyurea is permitted
- Received immunoglobulin within 6 months before receipt of study vaccine
- Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included
- Recent history (within the last year) of more than 3 inpatient hospitalizations
- At the time of signing informed consent/assent, is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator
- History or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study in the opinion of the Investigator
- Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
United States6 sites
Children's Healthcare of Atlanta ( Site 0100)
Atlanta, Georgia, 30303
Cincinnati Children's Hospital Medical Center ( Site 0101)
Cincinnati, Ohio, 45229
Children's Hospital of Michigan ( Site 0111)
Detroit, Michigan, 48201
Newark Beth Israel Medical Center ( Site 0115)
Newark, New Jersey, 07112
University of Rochester Medical Center ( Site 0105)
Rochester, New York, 14642
Nemours/Alfred I. duPont Hospital for Children ( Site 0113)
Wilmington, Delaware, 19803
Brazil3 sites
Santa Casa de Misericordia de Belo Horizonte ( Site 0200)
Belo Horizonte, Minas Gerais, 30150-221
Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)
Salvador, 40420-000
Santa Casa de Misericordia de Sao Paulo ( Site 0202)
São Paulo, 01221-900
Dominican Republic3 sites
Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402)
Distrito Nacional, Santo Domingo Province, 10204
Clinical Research Republica Dominicana ( Site 0401)
Santo Domingo, 10122
Caimed Dominicana S.A.S ( Site 0400)
Santo Domingo, 10205
Colombia2 sites
Clinica de la Costa Ltda. ( Site 0300)
Barranquilla, Atlántico, 080020
Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301)
Cali, Valle del Cauca Department, 760045
Greece2 sites
Agia Sophia Children s Hospital ( Site 0700)
Athens, 115 27
Hippokration General Hospital of Thessaloniki ( Site 0701)
Thessaloniki, 546 42
Panama2 sites
Cevaxin ( Site 0500)
Panama City, 0816-00383
Cevaxin ( Site 0502)
Panama City, 0816-00383
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
- Conditions
- Pneumococcal Infections
- Being tested
- V114, Prevnar 13™
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V114Biological
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™Biological
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
| Study group | Role | What they receive |
|---|---|---|
| V114 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1. Receives: Biological: V114 |
| Prevnar 13™ | Active comparator | Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1. Receives: Biological: Prevnar 13™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Measured: Up to 14 days post-vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Measured: Up to 14 days post-vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Measured: Up to 6 months post-vaccination
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Measured: Day 30
Secondary outcomes (3)
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
Measured: Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Measured: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Measured: Day 1 (Baseline) and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start23 Jan 2019
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731182
- Sponsor's protocol ID
- V114-023
- Other IDs
- V114-023, 2018-001152-35, 2018
- Status last verified
- May 2021
- First submitted
- 2 Nov 2018
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Quinn CT, Wiedmann RT, Jarovsky D, Lopez-Medina E, Rodriguez HM, Papa M, Boggio G, Shou Q, Dagan R, Richmond P, Feemster K, McFetridge R, Tamms G, Lupinacci R, Musey L, Bickham K. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023 Feb 14;7(3):414-421. doi: 10.1182/bloodadvances.2022008037.
PubMed 36383730
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
- ClinicalTrials.gov ID
- NCT03731182
- Acronym / sponsor ID
- V114-023
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V114 | Experimental | Biological: V114Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1. |
| Prevnar 13™ | Active comparator | Biological: Prevnar 13™Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Documented diagnosis of sickle cell disease in their medical record
- Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
- 1) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.
Key exclusion criteria (18 listed)
- History of Invasive Pneumococcal Disease (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)
- Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency
- Documented human immunodeficiency virus (HIV) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V114V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose | Biological | V114 |
| Prevnar 13™Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose | Biological | Prevnar 13™ |
Primary outcome
Percentage of Participants With a Solicited Injection-site Adverse Event
Time frame: Up to 14 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Percentage of Participants With a Solicited Systemic Adverse Event
Time frame: Up to 14 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Percentage of Participants With a Vaccine-related Serious Adverse Event
Time frame: Up to 6 months post-vaccination
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Time frame: Day 30
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
3 secondary outcomes
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Time frame: Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Time frame: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Time frame: Day 1 (Baseline) and Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36383730Quinn CT, Wiedmann RT, Jarovsky D, Lopez-Medina E, Rodriguez HM, Papa M, Boggio G, Shou Q, Dagan R, Richmond P, Feemster K, McFetridge R, Tamms G, Lupinacci R, Musey L, Bickham K. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023 Feb 14;7(3):414-421. doi: 10.1182/bloodadvances.2022008037.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V114 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Brazil, Dominican Republic, Colombia, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Solicited Injection-site Adverse Event (time frame: Up to 14 days post-vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03731182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021; AzTrials last refreshed its copy on 1 Nov 2026.