Streptococcus Pneumoniae InfectionPhase 1/2NCT02037984

Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)

A Phase 1/2 study testing Prevnar 13®, V114 1x:1x:1x and V114 2x:2x:2x in people with Streptococcus Pneumoniae Infection and Pneumococcal Infections, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2. Read more about this study

Who is it for?: Ages 6 weeks to 49 yearsHealthy volunteers can take part
Conditions the study is for: Streptococcus Pneumoniae Infection, Pneumococcal Infections
What is being tested?: Prevnar 13®, V114 1x:1x:1x and V114 2x:2x:2x
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: No sites listed yet
Study dates: 28 Jan 2014to 1 Jul 2016
Phase: Phase 1/2
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 6 weeks to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Infants:
Healthy and able to attend all scheduled visits.
Adults:
Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.

Who cannot join

Infants and Adults:
Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
History of invasive pneumococcal disease.
Known hypersensitivity to any vaccine component.
Received systemic corticosteroids within 14 days of first vaccination.
Known or suspected impairment of immune function.

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Febrile illness within 72 hours before vaccination.
Received blood transfusion or blood products within 30 days. Infants
Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
Has asplenia or failure to thrive.
Adults:
Is breastfeeding.

About this study

Official title: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants

Conditions: Streptococcus Pneumoniae Infection, Pneumococcal Infections
Being tested: Prevnar 13®, V114 1x:1x:1x, V114 2x:2x:2x, V114 2x:1x:2x, V114 1x:1x:2x
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prevnar 13®Biological
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.
V114 1x:1x:1xBiological
V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).
V114 2x:2x:2xBiological
V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
V114 2x:1x:2xBiological
V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
V114 1x:1x:2xBiological
V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
V114 0.5x:0.5x:2xBiological
V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

Study groups in NCT02037984
Study group	Role	What they receive
Adult V114: 1x:1x:1x	Experimental	Adults receive a single vaccination on Day 1. Receives: Biological: V114 1x:1x:1x
Adult V114: 2x:2x:2x	Experimental	Adults receive a single vaccination on Day 1. Receives: Biological: V114 2x:2x:2x
Infant V114: 1x:1x:1x	Experimental	Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 1x:1x:1x
Infant V114: 2x:1x:2x	Experimental	Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 2x:1x:2x
Infant V114: 2x:2x:2x	Experimental	Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 2x:2x:2x
Infant V114: 0.5x:0.5x:2x	Experimental	Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 0.5x:0.5x:2x
Infant V114: 1x:1x:2x	Experimental	Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 1x:1x:2x
Infant Prevnar 13®	Active comparator	Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: Prevnar 13®

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 days
Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 days
Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Measured: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Measured: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Measured: Month 7 (1 month PD3)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Measured: Month 7 (1 month PD3)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Measured: Month 7 (1 month PD3)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Measured: Month 7 (1 month PD3)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Measured: Month 7 (1 month PD3)
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
A mulitvariate regression model was used to evaluate the impact of increasing polysaccharide concentration from 1x to 2x on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase from 1x to 2x in polysaccharide concentration. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values >1.0 show an increase in antibody concentration whereas values <1.0 show a decrease in antibody concentration.
Measured: Month 7 (1 month PD3)
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
A mulitvariate regression model was used to evaluate the impact of increasing APA concentration on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase in APA. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values >1.0 show an increase in antibody concentration whereas values <1.0 show a decrease in antibody concentration.
Measured: Month 7 (1 month PD3)

Secondary outcomes (10)

Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 2x APA and varying pneumococcal polysaccharide.
Measured: Month 7 (1 month PD3)
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 1x APA and varying pneumococcal polysaccharide.
Measured: Month 7 (1 month PD3)
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Measured: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Measured: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Measured: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Measured: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.
Measured: One month following the 4th vaccination (approximately 13 to 16 months of age).
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD4 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.
Measured: One month following the 4th vaccination (approximately 13 to 16 months of age)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Measured: Month 2 (1 month after a single vaccination)
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
The percentage of participants with ≥4-fold-rise from baseline in each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.
Measured: Month 2 (1 month after a single vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 20141 Jul 2016

First posted16 Jan 2014 (estimated)
Study start28 Jan 2014
Primary completion1 Jul 2016
Study completion1 Jul 2016

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 Streptococcus Pneumoniae InfectionStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02037984
Sponsor's protocol ID: V114-004
Status last verified: Jun 2019
First submitted: 14 Jan 2014
Last updated: 24 Jun 2019
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

Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.
PubMed 30689507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

All Streptococcus Pneumoniae Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants
ClinicalTrials.gov ID: NCT02037984
Acronym / sponsor ID: V114-004
Conditions: Streptococcus Pneumoniae Infection, Pneumococcal Infections
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 28 Jan 2014 (actual)
Primary completion: 1 Jul 2016 (actual)
Study completion: 1 Jul 2016 (actual)
First posted: 16 Jan 2014 (estimated)
Results: Posted 30 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 8

Arm	Type	Receives
Adult V114: 1x:1x:1x	Experimental	Biological: V114 1x:1x:1xAdults receive a single vaccination on Day 1.
Adult V114: 2x:2x:2x	Experimental	Biological: V114 2x:2x:2xAdults receive a single vaccination on Day 1.
Infant V114: 1x:1x:1x	Experimental	Biological: V114 1x:1x:1xInfants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infant V114: 2x:1x:2x	Experimental	Biological: V114 2x:1x:2xInfants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infant V114: 2x:2x:2x	Experimental	Biological: V114 2x:2x:2xInfants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infant V114: 0.5x:0.5x:2x	Experimental	Biological: V114 0.5x:0.5x:2xInfants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infant V114: 1x:1x:2x	Experimental	Biological: V114 1x:1x:2xInfants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Infant Prevnar 13®	Active comparator	Biological: Prevnar 13®Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.

Who may qualify

Ages: 6 weeks to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Healthy and able to attend all scheduled visits.
Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.

Key exclusion criteria (12 listed)

Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
History of invasive pneumococcal disease.
Known hypersensitivity to any vaccine component.
Received systemic corticosteroids within 14 days of first vaccination.
Known or suspected impairment of immune function.

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
Prevnar 13®Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.	Biological	Infant Prevnar 13®
V114 1x:1x:1xV114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).	Biological	Adult V114: 1x:1x:1x, Infant V114: 1x:1x:1x
V114 2x:2x:2xV114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.	Biological	Adult V114: 2x:2x:2x, Infant V114: 2x:2x:2x
V114 2x:1x:2xV114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.	Biological	Infant V114: 2x:1x:2x
V114 1x:1x:2xV114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.	Biological	Infant V114: 1x:1x:2x
V114 0.5x:0.5x:2xV114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.	Biological	Infant V114: 0.5x:0.5x:2x

Primary outcome

Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to 14 days
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
Time frame: Up to 14 days
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
Time frame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
Time frame: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
Time frame: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
Time frame: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
Time frame: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
Time frame: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
Time frame: Month 7 (1 month PD3)
A mulitvariate regression model was used to evaluate the impact of increasing polysaccharide concentration from 1x to 2x on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase from 1x to 2x in polysaccharide concentration. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values >1.0 show an increase in antibody concentration whereas values <1.0 show a decrease in antibody concentration.
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
Time frame: Month 7 (1 month PD3)
A mulitvariate regression model was used to evaluate the impact of increasing APA concentration on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase in APA. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values >1.0 show an increase in antibody concentration whereas values <1.0 show a decrease in antibody concentration.

10 secondary outcomes

Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
Time frame: Month 7 (1 month PD3)
Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
Time frame: Month 7 (1 month PD3)
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age).
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
Time frame: One month following the 4th vaccination (approximately 13 to 16 months of age)
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
Time frame: Month 2 (1 month after a single vaccination)
Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
Time frame: Month 2 (1 month after a single vaccination)

Results and safety

Results posted to the registry on 30 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult V114: 1x:1x:1x	20	19
Adult V114: 2x.2x.2x	20	20
Infant V114: 1x:1x:1x	50	38
Infant V114: 2x:1x:2x	51	30
Infant V114: 2x:2x:2x	50	38
Infant V114: 0.5x:0.5x:2x	49	37
Infant V114: 1x:1x:2x	50	33
Infant Prevnar 13®	51	39

Primary outcome: Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)

Time frame: Up to 14 days. Number. Unit: Percentage of Participants

Measure	Adult V114: 1x:1x:1x n = 20	Adult V114: 2x.2x.2x n = 20
Value	100.0	100.0

Population analysed: Adult participants who received V114 are included.

Primary outcome: Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)

Time frame: Up to 14 days. Number. Unit: Percentage of Participants

Measure	Adult V114: 1x:1x:1x n = 20	Adult V114: 2x.2x.2x n = 20
Value	0.0	0.0

Population analysed: Adult participants who received V114 are included.

Primary outcome: Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)

Time frame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age). Number. Unit: Percentage of Participants

Measure	Infant V114: 1x:1x:1x n = 50	Infant V114: 2x:1x:2x n = 51	Infant V114: 2x:2x:2x n = 50	Infant V114: 0.5x:0.5x:2x n = 48	Infant V114: 1x:1x:2x n = 50	Infant Prevnar 13® n = 51
Value	98.0	100.0	96.0	97.9	98.0	98.0

Population analysed: Infant participants who received V114 are included.

Primary outcome: Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)

Time frame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age). Number. Unit: Percentage of Participants

Measure	Infant V114: 1x:1x:1x n = 50	Infant V114: 2x:1x:2x n = 51	Infant V114: 2x:2x:2x n = 50	Infant V114: 0.5x:0.5x:2x n = 48	Infant V114: 1x:1x:2x n = 50	Infant Prevnar 13® n = 51
Value	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: Infant participants who received V114 are included.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days after each dose of study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult: V114-1x:1x:1x	0 of 20 (0%)	20 of 20 (100%)	0 of 20
Adult: V114-2x:2x:2x	0 of 20 (0%)	20 of 20 (100%)	0 of 20
Infant: V114-1x:1x:1x	1 of 50 (2%)	49 of 50 (98%)	0 of 50
Infant: V114-2x:1x:2x	4 of 51 (7.8%)	51 of 51 (100%)	0 of 51
Infant: V114-2x:2x:2x	3 of 50 (6%)	48 of 50 (96%)	0 of 50
Infant: V114-0.5x:0.5x:2x	3 of 48 (6.3%)	46 of 48 (95.8%)	0 of 48
Infant: V114-1x:1x:2x	0 of 50 (0%)	49 of 50 (98%)	0 of 50
Infant: Prevnar 13	5 of 51 (9.8%)	50 of 51 (98%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30689507Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prevnar 13®, V114 1x:1x:1x and V114 2x:2x:2x in people with Streptococcus Pneumoniae Infection and Pneumococcal Infections, run by Merck Sharp & Dohme LLC.

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 12 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 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 Apr 2019). 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 Adult Participants Experiencing ≥1 Adverse Event (AE) (time frame: Up to 14 days). The study lists 11 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 NCT02037984, 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 24 Jun 2019.