Pneumococcal InfectionsPhase 2NCT01215188

A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)

A Phase 2 study testing V114 Aluminum-adjuvanted, V114 Non-adjuvanted and Prevnar 13® in people with 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 will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13® Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114 Aluminum-adjuvanted, V114 Non-adjuvanted and Prevnar 13®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,152 participants
Where: No sites listed yet
Study dates: 14 Oct 2010to 31 Jul 2012
Phase: Phase 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 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy infants ≥ 42 days to ≤ 89 days.
Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent.
Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
Participant is able to attend all scheduled visits and to comply with the study procedures.
Participant's parent/legal guardian has access to a telephone.

Who cannot join

Prior administration of any pneumococcal vaccine.
Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
Known or suspected impairment of immunological function.
Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
Participant or his/her mother has documented human immunodeficiency virus (HIV) infection.
Functional or anatomic asplenia.

Show all 22Show fewer

History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.
Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
Participant has received other licensed non-live vaccines within the 14 days before receipt of study vaccine.
Participant has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine.
Prior receipt of a blood transfusion or blood products, including immunoglobulins.
Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
A recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring within 72 hours before receipt of study vaccine.
History of failure to thrive.
Participant has a coagulation disorder contraindicating IM vaccination.
Participant and his/her mother have documented hepatitis B surface antigen-positive.
Any infant who cannot be adequately followed for safety according to the protocol plan.
Participant's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

About this study

Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants

Conditions: Pneumococcal Infections
Being tested: V114 Aluminum-adjuvanted, V114 Non-adjuvanted, Prevnar 13®
Keywords: Invasive pneumococcal disease, Pneumonia, Pneumococcal conjugate vaccine
Medical subject headings: Pneumococcal Infections, Pneumonia

What participants receive

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

V114 Aluminum-adjuvantedBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
V114 Non-adjuvantedBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.
Prevnar 13®Biological
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.

Study groups in NCT01215188
Study group	Role	What they receive
V114 Aluminum-adjuvanted	Experimental	Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 Aluminum-adjuvanted
V114 Non-adjuvanted	Experimental	Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 Non-adjuvanted
Prevnar 13®	Active comparator	Four IM doses at 0.5 mL of Prevnar 13® 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 Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence [Pn ECL] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay [WHO ELISA] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Measured: One month postvaccination 3
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Measured: One month postvaccination 3
IgG GMCs for Postvaccination 4
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Measured: One month postvaccination 4
Number of Participants With an Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Measured: Up to Day 14 postvaccination
Number of Participants With an Injection-site AE
Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed.
Measured: Up to Day 14 postvaccination
Number of Participants With a Systemic AE
Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed.
Measured: Up to Day 14 postvaccination
Number of Participants With a Serious Adverse Event (SAE)
An 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.
Measured: Up to one month after last dose of study vaccine
Number of Participants Who Discontinued the Study Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Measured: Up to Day 14 postvaccination

Secondary outcomes (6)

Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Measured: One month postvaccination 3
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Measured: One month postvaccination 4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Measured: One month postvaccination 3
OPA GMTs as Measured by MOPA4 for Postvaccination 4
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Measured: One month postvaccination 4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Measured: One month postvaccination 4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4
Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Measured: One month postvaccination 4

Timeline

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

14 Oct 201031 Jul 2012

First posted6 Oct 2010 (estimated)
Study start14 Oct 2010
Primary completion31 Jul 2012
Study completion31 Jul 2012

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215188
Sponsor's protocol ID: V114-003
Other IDs: V114-003
Status last verified: Apr 2019
First submitted: 4 Oct 2010
Last updated: 30 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, Stek JE, Abeygunawardana C, Winters MA, MacNair JE, Pujar NS, Musey L. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.
PubMed 30244873

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 Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants
ClinicalTrials.gov ID: NCT01215188
Acronym / sponsor ID: V114-003
Conditions: Pneumococcal Infections
Keywords: Invasive pneumococcal disease, Pneumonia, Pneumococcal conjugate vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,152 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 14 Oct 2010 (actual)
Primary completion: 31 Jul 2012 (actual)
Study completion: 31 Jul 2012 (actual)
First posted: 6 Oct 2010 (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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
V114 Aluminum-adjuvanted	Experimental	Biological: V114 Aluminum-adjuvantedFour intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
V114 Non-adjuvanted	Experimental	Biological: V114 Non-adjuvantedFour IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
Prevnar 13®	Active comparator	Biological: Prevnar 13®Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Healthy infants ≥ 42 days to ≤ 89 days.
Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent.
Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
Participant is able to attend all scheduled visits and to comply with the study procedures.

Key exclusion criteria (22 listed)

Prior administration of any pneumococcal vaccine.
Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
Known or suspected impairment of immunological function.
Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
Participant or his/her mother has 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
V114 Aluminum-adjuvanted15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.	Biological	V114 Aluminum-adjuvanted
V114 Non-adjuvanted15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.	Biological	V114 Non-adjuvanted
Prevnar 13®13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.	Biological	Prevnar 13®

Primary outcome

Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
Time frame: One month postvaccination 3
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence [Pn ECL] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay [WHO ELISA] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
Time frame: One month postvaccination 3
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
IgG GMCs for Postvaccination 4
Time frame: One month postvaccination 4
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Number of Participants With an Adverse Event (AE)
Time frame: Up to Day 14 postvaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Number of Participants With an Injection-site AE
Time frame: Up to Day 14 postvaccination
Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed.
Number of Participants With a Systemic AE
Time frame: Up to Day 14 postvaccination
Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed.
Number of Participants With a Serious Adverse Event (SAE)
Time frame: Up to one month after last dose of study vaccine
An 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.
Number of Participants Who Discontinued the Study Due to an AE
Time frame: Up to Day 14 postvaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

6 secondary outcomes

Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
Time frame: One month postvaccination 3
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
Time frame: One month postvaccination 4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
Time frame: One month postvaccination 3
OPA GMTs as Measured by MOPA4 for Postvaccination 4
Time frame: One month postvaccination 4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4
Time frame: One month postvaccination 4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4
Time frame: One month postvaccination 4

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
V114 Adjuvanted	378	320
V114 Nonadjuvanted	386	327
PREVNAR 13®	378	326

Primary outcome: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3

Time frame: One month postvaccination 3. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114 Adjuvanted n = 300	V114 Nonadjuvanted n = 315	PREVNAR 13® n = 315
Serotype 1	98.0 (95.7 to 99.3)	96.2 (93.4 to 98.0)	97.5 (95.1 to 98.9)
Serotype 3	93.3 (89.9 to 95.9)	89.8 (86.0 to 92.9)	69.2 (63.8 to 74.3)
Serotype 4	97.0 (94.4 to 98.6)	94.0 (90.7 to 96.3)	96.5 (93.8 to 98.2)
Serotype 5	95.7 (92.7 to 97.7)	92.4 (88.9 to 95.1)	96.2 (93.4 to 98.0)
Serotype 6A	77.0 (71.8 to 81.6)	78.4 (73.5 to 82.8)	96.8 (94.2 to 98.5)
Serotype 6B	73.7 (68.3 to 78.6)	65.4 (59.9 to 70.6)	87.6 (83.5 to 91.0)
Serotype 7F	99.0 (97.1 to 100)	99.4 (97.7 to 100)	99.4 (97.7 to 100)
Serotype 9V	95.0 (91.9 to 97.2)	92.4 (88.9 to 95.1)	97.5 (95.1 to 98.9)

Population analysed: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Primary outcome: IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3

Time frame: One month postvaccination 3. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	V114 Adjuvanted n = 300	V114 Nonadjuvanted n = 315	PREVNAR 13® n = 315
Serotype 1	1.34 (1.24 to 1.45)	1.38 (1.27 to 1.51)	1.84 (1.69 to 2.01)
Serotype 3	0.95 (0.88 to 1.03)	0.88 (0.81 to 0.96)	0.50 (0.46 to 0.55)
Serotype 4	1.28 (1.18 to 1.39)	1.26 (1.16 to 1.37)	1.32 (1.22 to 1.43)
Serotype 5	1.61 (1.46 to 1.77)	1.53 (1.38 to 1.71)	1.83 (1.65 to 2.02)
Serotype 6A	0.93 (0.80 to 1.08)	0.93 (0.80 to 1.07)	2.91 (2.62 to 3.24)
Serotype 6B	0.95 (0.78 to 1.15)	0.69 (0.57 to 0.84)	1.47 (1.27 to 1.69)
Serotype 7F	2.63 (2.41 to 2.87)	2.66 (2.44 to 2.90)	3.67 (3.40 to 3.97)
Serotype 9V	1.49 (1.35 to 1.64)	1.29 (1.16 to 1.44)	1.79 (1.63 to 1.97)

Population analysed: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Primary outcome: IgG GMCs for Postvaccination 4

Time frame: One month postvaccination 4. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	V114 Adjuvanted n = 275	V114 Nonadjuvanted n = 298	PREVNAR 13® n = 283
Serotype 1	1.91 (1.73 to 2.10)	1.81 (1.65 to 2.00)	2.18 (1.99 to 2.38)
Serotype 3	1.26 (1.15 to 1.39)	1.12 (1.04 to 1.22)	0.69 (0.63 to 0.75)
Serotype 4	1.46 (1.30 to 1.65)	1.40 (1.27 to 1.53)	1.68 (1.52 to 1.86)
Serotype 5	1.93 (1.74 to 2.14)	1.79 (1.63 to 1.97)	2.53 (2.28 to 2.81)
Serotype 6A	3.78 (3.37 to 4.26)	3.17 (2.81 to 3.57)	6.55 (5.89 to 7.28)
Serotype 6B	5.24 (4.68 to 5.86)	3.98 (3.52 to 4.51)	5.51 (4.90 to 6.20)
Serotype 7F	4.18 (3.76 to 4.64)	3.43 (3.14 to 3.75)	5.73 (5.24 to 6.28)
Serotype 9V	2.82 (2.52 to 3.15)	2.50 (2.28 to 2.75)	3.37 (3.04 to 3.72)

Population analysed: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Primary outcome: Number of Participants With an Adverse Event (AE)

Time frame: Up to Day 14 postvaccination. Count of participants. Unit: Participants

Measure	V114 Adjuvanted n = 368	V114 Nonadjuvanted n = 382	PREVNAR 13® n = 376
Value	349	359	354

Population analysed: The analysis population included all randomized participants who received at least one dose of study vaccination.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 month after final vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114	25 of 368 (6.8%)	345 of 368 (93.8%)	1 of 368
V114 Non-Adjuvanted	27 of 382 (7.1%)	348 of 382 (91.1%)	1 of 382
Prevnar	29 of 376 (7.7%)	347 of 376 (92.3%)	2 of 376

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30244873Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, Stek JE, Abeygunawardana C, Winters MA, MacNair JE, Pujar NS, Musey L. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.
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 2 study testing V114 Aluminum-adjuvanted, V114 Non-adjuvanted and Prevnar 13® in people with 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 6 inclusion and 22 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 30 Apr 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 phase mean?

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 Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 (time frame: One month postvaccination 3). The study lists 8 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 NCT01215188, 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 30 Apr 2019.