Pneumococcal InfectionsPhase 1NCT01215175

Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

A Phase 1 study testing Prevnar™, V114, Aluminum Adjuvanted and V114, Aluminum Nonadjuvanted 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

Search all trials

Trial summary

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers. Read more about this study

Who is it for?: Ages 12 months to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: Prevnar™, V114, Aluminum Adjuvanted and V114, Aluminum Nonadjuvanted
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: No sites listed yet
Study dates: 25 Sep 2009to 5 Jan 2011
Phase: Phase 1
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 12 months to 45 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Adult Stage:
Adults ≥18 to 45 years of age in good health.
Signed and dated informed consent prior to receipt of vaccine.
Afebrile (<100.4°F [<38.0°C] oral or equivalent) on day of vaccination.
Participant is able to read, understand, and complete study questionnaires (i.e., the Vaccine Report Card).
Participant is able to attend all scheduled visits and to comply with the study procedures.

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Participant has access to a telephone.
Females must have a negative urine pregnancy test.
Toddler Stage:
Healthy toddlers, 12-15 months of age who have previously completed a documented full 3 dose infant series of Prevnar™ at 2, 4, and 6 months of age.
Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees 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

Adult Stage:
Receipt of any pneumococcal polysaccharide vaccine at any time or receipt of polysaccharide conjugate vaccine after the second year of life.
Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
Known or suspected immunocompromised persons, including persons with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record ≥3 mg/dL), nephritic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplant.
Functional or anatomic asplenia.
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.

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History of chronic fatigue syndrome.
Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis (ADEM), pervasive developmental disorder, and related disorders.
Participant has a coagulation disorder contraindicating IM vaccination.
Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 30 days prior to Visit 1 through Visit 2, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) daily and for >2 weeks. 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.
Any underlying illness that would complicate evaluation and completion of this study.
Any licensed non-live virus vaccine administered within the 14 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine. (Exception: Inactivated influenza vaccine may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.)
Participant has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive vaccination with a licensed live virus vaccine within 30 days of receipt of study vaccine.
Participant has received diphtheria toxoid within 6 months prior to receipt of study vaccine.
Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine.
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.
Recent hospitalization for acute illness within the 3 months before receipt of study vaccine.
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.
History of febrile illness (≥100.40 F [≥38.00 C] oral or equivalent) occurring within 72 hours before receipt of study vaccine.
Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. Female participants of reproductive potential must have been using 2 acceptable methods of birth control for 2 weeks prior to enrollment, and agree to use 2 acceptable methods of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence).
Any participant who cannot be adequately followed for safety according to the protocol plan.
Participant 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.
Toddler Stage:
Have received less than the full 3-dose infant series of Prevnar™ or 3rd dose less than 2 months before study 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 HIV infection.
Functional or anatomic asplenia.
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.
Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. (Note: Toddlers on topical and inhaled/nebulized steroids may participate in the study.) Use of systemic steroids are only permitted when the participant is receiving less than 2 mg/kg per day of prednisone (or its equivalent), or less than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised.
Participant has received other licensed non-live vaccines administered within the 14 days before receipt of study vaccine.
Participant has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine (Exception: Influenza virus vaccine given according to recommended guidelines within 7 days of receiving 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 (<72 hours) febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring within 48 hours before receipt of study vaccine.
History of failure to thrive.
Participant has a coagulation disorder contraindicating IM vaccination.
Participant and his/her mother is documented hepatitis B surface antigen-positive.
Any toddler 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™ in Healthy Adults and Toddlers

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Read the detailed description

The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.

Conditions: Pneumococcal Infections
Being tested: Prevnar™, V114, Aluminum Adjuvanted, V114, Aluminum Nonadjuvanted
Keywords: Pneumococcal vaccines
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™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) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
V114, Aluminum AdjuvantedBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
V114, Aluminum NonadjuvantedBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.

Study groups in NCT01215175
Study group	Role	What they receive
Prevnar™ - Adult Cohort	Active comparator	Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. Receives: Biological: Prevnar™
V114 Adjuvanted -Toddler Cohort	Experimental	Healthy toddler (12-15 months of age) participants who had completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. Receives: Biological: V114, Aluminum Adjuvanted
V114 Nonadjuvanted-Toddler Cohort	Experimental	Healthy toddlers (12-15 months of age) participants who completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of non-adjuvanted V114 on Day 1. Receives: Biological: V114, Aluminum Nonadjuvanted
Prevnar™- Toddler Cohort	Active comparator	Healthy toddlers (12-15 months of age) participants who had previously completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. Receives: Biological: Prevnar™
V114 Adjuvanted -Adult Cohort	Experimental	Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. Receives: Biological: V114, Aluminum Adjuvanted

What is being measured

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

Adult: Percentage of Participants With Any Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to Day 14 after vaccination
Toddler: Percentage of Participants With Any Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to Day 14 after vaccination
Adult: Percentage of Participants With Any 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.
Measured: Up to Day 14 after vaccination
Toddler: Percentage of Participants With Any 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.
Measured: Up to Day 14 after vaccination
Adult: Percentage of Participants With Any Vaccine-related Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Measured: Up to Day 14 after vaccination
Toddler: Percentage of Participants With Any Vaccine-related Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Measured: Up to Day 14 after vaccination

Secondary outcomes (8)

Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL
Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.
Measured: Day 30 after vaccination
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL
Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.
Measured: Day 30 after vaccination
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: Day 30 after vaccination
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: Day 30 after vaccination
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.
Measured: Day 30 after vaccination
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.
Measured: Day 30 after vaccination
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay
Measured: Day 30 after vaccination
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay
Measured: Day 30 after vaccination

Timeline

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

25 Sep 20095 Jan 2011

First posted6 Oct 2010 (estimated)
Study start25 Sep 2009
Primary completion16 Apr 2010
Study completion5 Jan 2011

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 (2)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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215175
Sponsor's protocol ID: V114-001
Other IDs: 2009-015103-58, V114-001, 2009
Status last verified: Mar 2019
First submitted: 4 Oct 2010
Last updated: 18 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Sobanjo-ter Meulen A, Vesikari T, Malacaman EA, Shapiro SA, Dallas MJ, Hoover PA, McFetridge R, Stek JE, Marchese RD, Hartzel J, Watson WJ, Musey LK. Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2015 Feb;34(2):186-94. doi: 10.1097/INF.0000000000000516.
PubMed 25741971
McFetridge R, Meulen AS, Folkerth SD, Hoekstra JA, Dallas M, Hoover PA, Marchese RD, Zacholski DM, Watson WJ, Stek JE, Hartzel JS, Musey LK. Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2015 Jun 4;33(24):2793-9. doi: 10.1016/j.vaccine.2015.04.025. Epub 2015 Apr 23.
PubMed 25913828

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 18 Mar 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™ in Healthy Adults and Toddlers
ClinicalTrials.gov ID: NCT01215175
Acronym / sponsor ID: V114-001
Conditions: Pneumococcal Infections
Keywords: Pneumococcal vaccines
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Sep 2009 (actual)
Primary completion: 16 Apr 2010 (actual)
Study completion: 5 Jan 2011 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 18 Mar 2019

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 being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Detailed description

The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Prevnar™ - Adult Cohort	Active comparator	Biological: Prevnar™Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
V114 Adjuvanted -Toddler Cohort	Experimental	Biological: V114, Aluminum AdjuvantedHealthy toddler (12-15 months of age) participants who had completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
V114 Nonadjuvanted-Toddler Cohort	Experimental	Biological: V114, Aluminum NonadjuvantedHealthy toddlers (12-15 months of age) participants who completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of non-adjuvanted V114 on Day 1.
Prevnar™- Toddler Cohort	Active comparator	Biological: Prevnar™Healthy toddlers (12-15 months of age) participants who had previously completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
V114 Adjuvanted -Adult Cohort	Experimental	Biological: V114, Aluminum AdjuvantedHealthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

Who may qualify

Ages: 12 months to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (15 listed)

Adults ≥18 to 45 years of age in good health.
Signed and dated informed consent prior to receipt of vaccine.
Afebrile (<100.4°F [<38.0°C] oral or equivalent) on day of vaccination.
Participant is able to read, understand, and complete study questionnaires (i.e., the Vaccine Report Card).
Participant is able to attend all scheduled visits and to comply with the study procedures.

Key exclusion criteria (47 listed)

Receipt of any pneumococcal polysaccharide vaccine at any time or receipt of polysaccharide conjugate vaccine after the second year of life.
Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
Known or suspected immunocompromised persons, including persons with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record ≥3 mg/dL), nephritic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplant.
Functional or anatomic asplenia.
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.

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-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) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.	Biological	Prevnar™ - Adult Cohort, Prevnar™- Toddler Cohort
V114, Aluminum Adjuvanted15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.	Biological	V114 Adjuvanted -Adult Cohort, V114 Adjuvanted -Toddler Cohort
V114, Aluminum Nonadjuvanted15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.	Biological	V114 Nonadjuvanted-Toddler Cohort

Primary outcome

Adult: Percentage of Participants With Any Adverse Event
Time frame: Up to Day 14 after vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Toddler: Percentage of Participants With Any Adverse Event
Time frame: Up to Day 14 after vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Adult: Percentage of Participants With Any Serious Adverse Event
Time frame: Up to Day 14 after 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.
Toddler: Percentage of Participants With Any Serious Adverse Event
Time frame: Up to Day 14 after 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.
Adult: Percentage of Participants With Any Vaccine-related Adverse Event
Time frame: Up to Day 14 after vaccination
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Toddler: Percentage of Participants With Any Vaccine-related Adverse Event
Time frame: Up to Day 14 after vaccination
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.

8 secondary outcomes

Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL
Time frame: Day 30 after vaccination
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL
Time frame: Day 30 after vaccination
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies
Time frame: Day 30 after vaccination
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies
Time frame: Day 30 after vaccination
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8
Time frame: Day 30 after vaccination
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8
Time frame: Day 30 after vaccination
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
Time frame: Day 30 after vaccination
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
Time frame: Day 30 after vaccination

Results and safety

Results posted to the registry on 18 Mar 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 - Adult Cohort	30	30
Prevnar™ - Adult Cohort	30	29
V114 Adjuvanted - Toddler Cohort	33	33
V114 Nonadjuvanted-Toddler Cohort	29	28
Prevnar™ - Toddler Cohort	28	28

Primary outcome: Adult: Percentage of Participants With Any Adverse Event

Time frame: Up to Day 14 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 Adjuvanted - Adult Cohort n = 30	Prevnar™ - Adult Cohort n = 30
Value	93.3	83.3

V114 Adjuvanted - Adult Cohort vs Prevnar™ - Adult Cohort: Risk Difference (RD): 10.0 (95% CI -7.4 to 28.3)

Population analysed: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

Primary outcome: Toddler: Percentage of Participants With Any Adverse Event

Time frame: Up to Day 14 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 Adjuvanted - Toddler Cohort n = 33	V114 Nonadjuvanted-Toddler Cohort n = 28	Prevnar™ - Toddler Cohort n = 28
Value	93.9	89.3	85.7

V114 Adjuvanted - Toddler Cohort vs Prevnar™ - Toddler Cohort: Risk Difference (RD): 8.2 (95% CI -7.9 to 26.6)
V114 Nonadjuvanted-Toddler Cohort vs Prevnar™ - Toddler Cohort: Risk Difference (RD): 3.6 (95% CI -15.5 to 22.9)

Population analysed: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

Primary outcome: Adult: Percentage of Participants With Any Serious Adverse Event

Time frame: Up to Day 14 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 Adjuvanted - Adult Cohort n = 30	Prevnar™ - Adult Cohort n = 30
Value	0.0	0.0

V114 Adjuvanted - Adult Cohort vs Prevnar™ - Adult Cohort: Risk Difference (RD): 0.0 (95% CI -11.5 to 11.5)

Population analysed: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

Primary outcome: Toddler: Percentage of Participants With Any Serious Adverse Event

Time frame: Up to Day 14 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 Adjuvanted - Toddler Cohort n = 33	V114 Nonadjuvanted-Toddler Cohort n = 28	Prevnar™ - Toddler Cohort n = 28
Value	0.0	0.0	0.0

V114 Adjuvanted - Toddler Cohort vs Prevnar™ - Toddler Cohort: Risk Difference (RD): 0.0 (95% CI -12.2 to 10.6)
V114 Nonadjuvanted-Toddler Cohort vs Prevnar™ - Toddler Cohort: Risk Difference (RD): 0.0 (95% CI -12.3 to 12.3)

Population analysed: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 month after vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114 Adjuvanted -Adult Cohort	0 of 30 (0%)	28 of 30 (93.3%)	0 of 30
PREVNAR™-Adult Cohort	0 of 30 (0%)	25 of 30 (83.3%)	0 of 30
V114 Adjuvanted- Toddler Cohort	0 of 33 (0%)	31 of 33 (93.9%)	0 of 33
V114 Nonadjuvanted-toddler Cohort	0 of 28 (0%)	25 of 28 (89.3%)	0 of 28
PREVNAR™- Toddler Cohort	0 of 28 (0%)	24 of 28 (85.7%)	0 of 28

Limitations and caveats (from the sponsor): Data related to the IgG antibody response of serotype 22F in the toddler samples were considered experimental due to failure of assay validity criteria.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25741971Sobanjo-ter Meulen A, Vesikari T, Malacaman EA, Shapiro SA, Dallas MJ, Hoover PA, McFetridge R, Stek JE, Marchese RD, Hartzel J, Watson WJ, Musey LK. Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2015 Feb;34(2):186-94. doi: 10.1097/INF.0000000000000516.
Derived from this study: PubMed 25913828McFetridge R, Meulen AS, Folkerth SD, Hoekstra JA, Dallas M, Hoover PA, Marchese RD, Zacholski DM, Watson WJ, Stek JE, Hartzel JS, Musey LK. Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2015 Jun 4;33(24):2793-9. doi: 10.1016/j.vaccine.2015.04.025. Epub 2015 Apr 23.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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 study testing Prevnar™, V114, Aluminum Adjuvanted and V114, Aluminum Nonadjuvanted 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 15 inclusion and 47 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 18 Mar 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 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.

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 18 Mar 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?

Adult: Percentage of Participants With Any Adverse Event (time frame: Up to Day 14 after vaccination). The study lists 6 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 NCT01215175, which also lists 2 linked publications.

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 18 Mar 2019.