Pneumococcal InfectionsPhase 1/2NCT02531373

A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

A Phase 1/2 study testing V114 Medium Dose, V114 High Dose and V114 Medium Dose with Alternative Carrier Protein 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 is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants. Read more about this study

Who is it for?: Ages 2 months to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114 Medium Dose, V114 High Dose and V114 Medium Dose with Alternative Carrier Protein
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 338 participants
Where: No sites listed yet
Study dates: 15 Sep 2015to 14 Apr 2017
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 2 months to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Adult Cohort: 18 to 49 years and in good health
Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Who cannot join

Adult cohort: Prior administration of any pneumococcal vaccine
History of invasive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected impairment of immune function
Coagulation disorder contraindicating intramuscular vaccination
Received a blood transfusion or blood products within 6 months

Show all 24Show fewer

Participated in another clinical study of an investigational product within 2 months
Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
Known hypersensitivity to any vaccine component
Known or suspected impairment of immune function
History of congenital or acquired immunodeficiency
Has or mother has documented Human Immunodeficiency virus (HIV) infection
Has or mother has documented hepatitis B surface antigen positive result
Functional or anatomic asplenia
History of failure to thrive
Coagulation disorder contraindicating intramuscular vaccination
History of autoimmune disease or autoimmune disorder
Known neurologic or cognitive behavioral disorder
Received systemic corticosteroids within 14 days
Received other licensed non-live vaccine within 14 days
Received other licensed live virus vaccine within 30 days
Received a blood transfusion or blood products
Participated in another clinical study of an investigational product
History of invasive pneumococcal disease

About this study

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

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Conditions: Pneumococcal Infections
Being tested: V114 Medium Dose, V114 High Dose, V114 Medium Dose with Alternative Carrier Protein, V114 High Dose with Alternative Carrier Protein, Prevnar 13™
Medical subject headings: Pneumococcal Infections

What participants receive

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

V114 Medium DoseBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
V114 High DoseBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
V114 Medium Dose with Alternative Carrier ProteinBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
V114 High Dose with Alternative Carrier ProteinBiological
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein 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) and 6B (4.4 mcg) in each 0.5 ml dose

Study groups in NCT02531373
Study group	Role	What they receive
Adult: V114 Medium Dose	Experimental	Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1. Receives: Biological: V114 Medium Dose
Adult: V114 High Dose	Experimental	Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1. Receives: Biological: V114 High Dose
Adult: V114 Medium Dose with Alternative Carrier Protein	Experimental	Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1. Receives: Biological: V114 Medium Dose with Alternative Carrier Protein
Adult: V114 High Dose with Alternative Carrier Protein	Experimental	Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1. Receives: Biological: V114 High Dose with Alternative Carrier Protein
Infant: V114 Medium Dose	Experimental	Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 Medium Dose
Infant: V114 High Dose	Experimental	Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 High Dose
Infant: V114 Medium Dose with Alternative Carrier Protein	Experimental	Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 Medium Dose with Alternative Carrier Protein
Infant: V114 High Dose with Alternative Carrier Protein	Experimental	Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114 High Dose with Alternative Carrier Protein
Infant: Prevnar 13™	Active comparator	Infant participants will receive a 0.5 mL intramuscular injection 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.

Adults: Percentage of Participants With an 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 6 weeks after vaccination
Infants: Percentage of Participants With an 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.
Measured: Up to 1 month after Vaccination 4 (Month 11-15)
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an 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.
Measured: Up to time of Vaccination 4 (Month 10-13)
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
Measured: Up to 14 days after any vaccination
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Measured: Up to 14 days after any vaccination
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: 1 month after Vaccination 3 (Month 5)

Secondary outcomes (7)

Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: 1 month after vaccination
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
Measured: Baseline and 1 month after vaccination
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: 1 month after Vaccination 3 (Month 5)
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: Before Vaccination 4 (Month 10-13)
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: 1 month after Vaccination 4 (Month 11-15)
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: Before Vaccination 4 (Month 10-13)
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Measured: 1 month after Vaccination 4 (Month 11-15)

Timeline

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

15 Sep 201514 Apr 2017

First posted24 Aug 2015 (estimated)
Study start15 Sep 2015
Primary completion14 Apr 2017
Study completion14 Apr 2017

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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 338 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02531373
Sponsor's protocol ID: V114-005
Status last verified: Mar 2019
First submitted: 20 Aug 2015
Last updated: 2 Apr 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

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease

All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 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 Different Formulations of V114 in Healthy Adults and Infants
ClinicalTrials.gov ID: NCT02531373
Acronym / sponsor ID: V114-005
Conditions: Pneumococcal Infections
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 338 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 15 Sep 2015 (actual)
Primary completion: 14 Apr 2017 (actual)
Study completion: 14 Apr 2017 (actual)
First posted: 24 Aug 2015 (estimated)
Results: Posted 17 Apr 2018

Clinical summary

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

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 9

Arm	Type	Receives
Adult: V114 Medium Dose	Experimental	Biological: V114 Medium DoseAdult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
Adult: V114 High Dose	Experimental	Biological: V114 High DoseAdult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
Adult: V114 Medium Dose with Alternative Carrier Protein	Experimental	Biological: V114 Medium Dose with Alternative Carrier ProteinAdult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
Adult: V114 High Dose with Alternative Carrier Protein	Experimental	Biological: V114 High Dose with Alternative Carrier ProteinAdult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
Infant: V114 Medium Dose	Experimental	Biological: V114 Medium DoseInfant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
Infant: V114 High Dose	Experimental	Biological: V114 High DoseInfant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
Infant: V114 Medium Dose with Alternative Carrier Protein	Experimental	Biological: V114 Medium Dose with Alternative Carrier ProteinInfant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
Infant: V114 High Dose with Alternative Carrier Protein	Experimental	Biological: V114 High Dose with Alternative Carrier ProteinInfant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
Infant: Prevnar 13™	Active comparator	Biological: Prevnar 13™Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.

Who may qualify

Ages: 2 months to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Adult Cohort: 18 to 49 years and in good health
Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Key exclusion criteria (24 listed)

Adult cohort: Prior administration of any pneumococcal vaccine
History of invasive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected impairment of immune function
Coagulation disorder contraindicating intramuscular vaccination

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 Medium Dose15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose	Biological	Adult: V114 Medium Dose, Infant: V114 Medium Dose
V114 High Dose15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose	Biological	Adult: V114 High Dose, Infant: V114 High Dose
V114 Medium Dose with Alternative Carrier Protein15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose	Biological	Adult: V114 Medium Dose with Alternative Carrier Protein, Infant: V114 Medium Dose with Alternative Carrier Protein
V114 High Dose with Alternative Carrier Protein15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose	Biological	Adult: V114 High Dose with Alternative Carrier Protein, Infant: V114 High Dose with Alternative Carrier Protein
Prevnar 13™13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose	Biological	Infant: Prevnar 13™

Primary outcome

Adults: Percentage of Participants With an Adverse Event
Time frame: Up to 6 weeks 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.
Infants: Percentage of Participants With an Adverse Event
Time frame: Up to 1 month after Vaccination 4 (Month 11-15)
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.
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
Time frame: Up to time of Vaccination 4 (Month 10-13)
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.
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Time frame: Up to 14 days after any vaccination
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Time frame: Up to 14 days after any vaccination
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Time frame: 1 month after Vaccination 3 (Month 5)
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

7 secondary outcomes

Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Time frame: 1 month after vaccination
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Time frame: Baseline and 1 month after vaccination
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3 (Month 5)
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Time frame: Before Vaccination 4 (Month 10-13)
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Time frame: 1 month after Vaccination 4 (Month 11-15)
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Time frame: Before Vaccination 4 (Month 10-13)
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Time frame: 1 month after Vaccination 4 (Month 11-15)

Results and safety

Results posted to the registry on 17 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adults: V114 Medium Dose	20	20
Adults: V114 High Dose	20	20
Adults: V114 Medium Dose + ACP	20	20
Adults: V114 High Dose + ACP	20	20
Infants: V114 Medium Dose	51	43
Infants: V114 High Dose	51	42
Infants: V114 Medium Dose + ACP	52	41
Infants: V114 High Dose + ACP	52	43
Infants: Prevnar 13™	52	43

Primary outcome: Adults: Percentage of Participants With an Adverse Event

Time frame: Up to 6 weeks after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Adults: V114 Medium Dose n = 20	Adults: V114 High Dose n = 20	Adults: V114 Medium Dose + ACP n = 20	Adults: V114 High Dose + ACP n = 20
Value	90.0 (68.3 to 98.8)	95.0 (75.1 to 99.9)	95.0 (75.1 to 99.9)	95.0 (75.1 to 99.9)

Population analysed: The analysis population included all randomized adult participants who received study vaccination.

Primary outcome: Infants: Percentage of Participants With an Adverse Event

Time frame: Up to 1 month after Vaccination 4 (Month 11-15). Number. Unit: Percentage of participants

Measure	Infants: V114 Medium Dose n = 50	Infants: V114 High Dose n = 50	Infants: V114 Medium Dose + ACP n = 51	Infants: V114 High Dose + ACP n = 52	Infants: Prevnar 13™ n = 52
Value	96.0	94.0	96.1	98.1	100.0

Infants: V114 Medium Dose vs Infants: Prevnar 13™: Risk Difference (RD): -4.0 (95% CI -13.5 to 3.1)
Infants: V114 High Dose vs Infants: Prevnar 13™: Risk Difference (RD): -6.0 (95% CI -16.3 to 1.2)
Infants: V114 Medium Dose + ACP vs Infants: Prevnar 13™: Risk Difference (RD): -3.9 (95% CI -13.3 to 3.2)

Population analysed: The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.

Primary outcome: Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event

Time frame: Up to time of Vaccination 4 (Month 10-13). Number. Unit: Percentage of participants

Measure	Infants: V114 Medium Dose n = 50	Infants: V114 High Dose n = 50	Infants: V114 Medium Dose + ACP n = 51	Infants: V114 High Dose + ACP n = 52	Infants: Prevnar 13™ n = 52
Value	0.0	0.0	0.0	0.0	0.0

Infants: V114 Medium Dose vs Infants: Prevnar 13™: Risk Difference (RD): 0.0 (95% CI -6.9 to 7.2)
Infants: V114 High Dose vs Infants: Prevnar 13™: Risk Difference (RD): 0.0 (95% CI -6.9 to 7.2)
Infants: V114 Medium Dose + ACP vs Infants: Prevnar 13™: Risk Difference (RD): 0.0 (95% CI -6.9 to 7.1)

Primary outcome: Infants: Percentage of Participants With a Solicited Injection-site Adverse Event

Time frame: Up to 14 days after any vaccination. Number. Unit: Percentage of participants

Measure	Infants: V114 Medium Dose n = 50	Infants: V114 High Dose n = 50	Infants: V114 Medium Dose + ACP n = 51	Infants: V114 High Dose + ACP n = 52	Infants: Prevnar 13™ n = 52
Value	78.0	80.0	58.8	80.8	57.7

Infants: V114 Medium Dose vs Infants: Prevnar 13™: Risk Difference (RD): 20.3 (95% CI 2.1 to 37.3), p = 0.029, Miettinen and Nurminen method
Infants: V114 High Dose vs Infants: Prevnar 13™: Risk Difference (RD): 22.3 (95% CI 4.3 to 39.1), p = 0.016, Miettinen and Nurminen method
Infants: V114 Medium Dose + ACP vs Infants: Prevnar 13™: Risk Difference (RD): 1.1 (95% CI -17.7 to 19.9), p = 0.908, Miettinen and Nurminen method

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adults: all AEs: up to 14 days after vaccination; SAEs: up to 6 weeks after vaccination; infants: All AEs: up to 14 days after any vaccination; SAEs: up to 6 weeks after Vaccination 4.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114 Medium Adults	0 of 20 (0%)	18 of 20 (90%)	0 of 20
V114 High Adults	0 of 20 (0%)	19 of 20 (95%)	0 of 20
V114 Medium + ACP Adults	0 of 20 (0%)	19 of 20 (95%)	0 of 20
V114 High + ACP Adults	0 of 20 (0%)	18 of 20 (90%)	0 of 20
V114 Medium Infants	5 of 50 (10%)	47 of 50 (94%)	0 of 50
V114 High Infants	4 of 50 (8%)	46 of 50 (92%)	0 of 50
V114 Medium + ACP Infants	1 of 51 (2%)	49 of 51 (96.1%)	0 of 51
V114 High + ACP Infants	3 of 52 (5.8%)	51 of 52 (98.1%)	0 of 52
Prevnar 13 Infants	4 of 52 (7.7%)	51 of 52 (98.1%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 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 V114 Medium Dose, V114 High Dose and V114 Medium Dose with Alternative Carrier Protein 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 3 inclusion and 24 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 2 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 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 17 Apr 2018). 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?

Adults: Percentage of Participants With an Adverse Event (time frame: Up to 6 weeks 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 NCT02531373, 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 2 Apr 2019.