Pneumococcal InfectionsPhase 3PNEU-PLANNCT03885934

Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)

A Phase 3 study testing V114 and Prevnar 13® in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 26 sites in 5 countries.

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

The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the… Read more about this study

Who is it for?: Ages 7 months to 17 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114 and Prevnar 13®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 606 participants
Where: 26 sitesin 5 countries
Study dates: 25 Jun 2019to 9 Dec 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 months to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Not be pregnant or breastfeeding
Not be a woman of childbearing potential
If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention
Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent

Who cannot join

History of invasive pneumococcal disease (IPD)
Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing vaccine
Had a recent febrile illness occurring within 72 hours prior to receipt of study vaccine
Known or suspected impairment of immunological function
History of congenital or acquired immunodeficiency
Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

Show all 17Show fewer

Known or history of functional or anatomic asplenia
Has failure to thrive based on the clinical judgement of the investigator
Has a bleeding disorder contraindicating intramuscular vaccination
Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
Has known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants ≥2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine
Meets one or more of the following systemic corticosteroid exclusion criteria: has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization; has received or is expected to receive systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days prior to any dose of study vaccine; or is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study (Note: Topical, ophthalmic and inhaled steroids are permitted)
Has received other licensed non-live vaccines within 14 days before receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine
Has received a licensed live vaccine within 30 days before receipt of study vaccine
Has received a blood transfusion or blood products, including immunoglobulins, within 6 months before receipt of study vaccine
Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study

Trial locations and contacts

26 sites in 5 countries.

Country

City, postcode or hospital

26 sites in 5 countries

Finland10 sites

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
Espoo, 02230
Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
Helsinki, 00100
Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
Helsinki, 00930
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
Jarvenpaa, 04400
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
Kokkola, 67100
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
Oulu, 90220
Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
Pori, 28100
Seinajoki Vaccine Research Center ( Site 0010)
Seinäjoki, 60100
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
Tampere, 33100
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
Turku, 20520

Other trials in Finland

Poland6 sites

Przychodnia Vitamed Gaaj i Cichomski Spolka Jawna ( Site 0212)
Bydgoszcz, 85-079
Centrum Medyczne Pratia Bydgoszcz ( Site 0210)
Bydgoszcz, 85-796
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0209)
Łomianki, 05-092
Spec Zesp Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu ( Site 0213)
Poznan, 61-709
NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0211)
Siemianowice Śląskie, 41-103
Uniwersytecki Szpital Kliniczny ( Site 0207)
Wroclaw, 50-368

Other trials in Poland

Russia4 sites

Central Clinical Hospital of Russian Academy Science ( Site 0317)
Moscow, 119333
Children s City Polyclinic No. 45 of the Nevsky District ( Site 0312)
Saint Petersburg, 193312
Research Institute of Children Infections ( Site 0301)
Saint Petersburg, 197022
MAI Childrens City Clinical Hospital 11 ( Site 0305)
Yekaterinburg, 620028

Other trials in Russia

Thailand4 sites

Chulalongkorn University ( Site 0601)
Bangkok, 10330
Vaccine Trial Center Faculty of Tropical Medicine ( Site 0603)
Bangkok, 10400
Siriraj Hospital ( Site 0600)
Bangkok, 10700
Srinagarind Hospital ( Site 0602)
Khonkaen, 40002

Other trials in Thailand

Malaysia2 sites

Sabah Womens & Childrens Hospital ( Site 0902)
Kota Kinabalu, 88996
University Malaya Medical Centre ( Site 0901)
Kuala Lumpur, 59100

Other trials in Malaysia

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)

Conditions: Pneumococcal Infections
Being tested: V114, Prevnar 13®
Medical subject headings: Pneumococcal Infections

What participants receive

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

V114Biological
Also called Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™
V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration
Prevnar 13®Biological
Also called PCV13
Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

Study groups in NCT03885934
Study group	Role	What they receive
V114, Schedule A: Participants 7-11 months	Experimental	Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Receives: Biological: V114
Prevnar 13®, Schedule A: Participants 7-11 months	Active comparator	Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. Receives: Biological: Prevnar 13®
V114, Schedule B: Participants 12-23 months	Experimental	Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Receives: Biological: V114
Prevnar 13®, Schedule B: Participants 12-23 months	Active comparator	Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. Receives: Biological: Prevnar 13®
V114, Schedule C: Participants 2-17 years	Experimental	Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. Receives: Biological: V114
Prevnar 13®, Schedule C: Participants 2-17 years	Active comparator	Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. Receives: Biological: Prevnar 13®

What is being measured

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

Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Measured: 30 days post last vaccination
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Measured: 30 days post last vaccination
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Measured: 30 days post vaccination
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Measured: Up to 14 days post any vaccination
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Measured: Up to 14 days post any vaccination
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Measured: Up to 14 days post vaccination
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Measured: Up to 14 days post any vaccination
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Measured: Up to 14 days post any vaccination
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Measured: Up to 14 days post vaccination
Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Measured: Up to ~6 months post final vaccination
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Measured: Up to ~6 months post final vaccination
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.
Measured: Up to ~6 months post vaccination

Secondary outcomes (3)

Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Measured: 30 days post final vaccination
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Measured: 30 days post final vaccination
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Measured: 30 days post vaccination

Timeline

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

25 Jun 20199 Dec 2020

First posted22 Mar 2019
Study start25 Jun 2019
Primary completion9 Dec 2020
Study completion9 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03885934
Sponsor's protocol ID: V114-024
Other IDs: 2018-003706-88, 2018
Acronym: PNEU-PLAN
Status last verified: Jan 2023
First submitted: 20 Mar 2019
Last updated: 13 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Banniettis N, Wysocki J, Szenborn L, Phongsamart W, Pitisuttithum P, Ramet M, Richmond P, Shi Y, Dagan R, Good L, Papa M, Lupinacci R, McFetridge R, Tamms G, Churchill C, Musey L, Bickham K; V114-024 PNEU-PLAN study group. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325. doi: 10.1016/j.vaccine.2022.09.003. Epub 2022 Sep 21.
PubMed 36150974

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)
ClinicalTrials.gov ID: NCT03885934
Acronym / sponsor ID: PNEU-PLAN / V114-024
Conditions: Pneumococcal Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Jun 2019 (actual)
Primary completion: 9 Dec 2020 (actual)
Study completion: 9 Dec 2020 (actual)
First posted: 22 Mar 2019 (actual)
Results: Posted 23 Sep 2021

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
V114, Schedule A: Participants 7-11 months	Experimental	Biological: V114Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
Prevnar 13®, Schedule A: Participants 7-11 months	Active comparator	Biological: Prevnar 13®Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
V114, Schedule B: Participants 12-23 months	Experimental	Biological: V114Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
Prevnar 13®, Schedule B: Participants 12-23 months	Active comparator	Biological: Prevnar 13®Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
V114, Schedule C: Participants 2-17 years	Experimental	Biological: V114Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
Prevnar 13®, Schedule C: Participants 2-17 years	Active comparator	Biological: Prevnar 13®Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

Who may qualify

Ages: 7 months to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Not be pregnant or breastfeeding
Not be a woman of childbearing potential
If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention
Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent

Key exclusion criteria (17 listed)

History of invasive pneumococcal disease (IPD)
Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing vaccine
Had a recent febrile illness occurring within 72 hours prior to receipt of study vaccine
Known or suspected impairment of immunological function
History of congenital or acquired immunodeficiency

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
V114Also: Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration	Biological	V114, Schedule A: Participants 7-11 months, V114, Schedule B: Participants 12-23 months, V114, Schedule C: Participants 2-17 years
Prevnar 13®Also: PCV13Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.	Biological	Prevnar 13®, Schedule A: Participants 7-11 months, Prevnar 13®, Schedule B: Participants 12-23 months, Prevnar 13®, Schedule C: Participants 2-17 years

Primary outcome

Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Time frame: 30 days post last vaccination
The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Time frame: 30 days post last vaccination
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Time frame: 30 days post vaccination
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
Time frame: Up to 14 days post any vaccination
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
Time frame: Up to 14 days post any vaccination
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
Time frame: Up to 14 days post vaccination
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
Time frame: Up to 14 days post any vaccination
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
Time frame: Up to 14 days post any vaccination
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Time frame: Up to 14 days post vaccination
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months
Time frame: Up to ~6 months post final vaccination
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months
Time frame: Up to ~6 months post final vaccination
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years
Time frame: Up to ~6 months post vaccination
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.

3 secondary outcomes

Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Time frame: 30 days post final vaccination
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Time frame: 30 days post final vaccination
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Time frame: 30 days post vaccination

Results and safety

Results posted to the registry on 23 Sep 2021, 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, Schedule A: Participants 7-11 Months	64	63
Prevnar 13®, Schedule A: Participants 7-11 Months	64	64
V114, Schedule B: Participants 12-23 Months	62	62
Prevnar 13®, Schedule B: Participants 12-23 Months	64	64
V114, Schedule C: Participants 2-17 Years	177	177
Prevnar 13®, Schedule C: Participants 2-17 Years	175	175

Primary outcome: Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months

Time frame: 30 days post last vaccination. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	V114, Schedule A: Participants 7-11 Months n = 64	Prevnar 13®, Schedule A: Participants 7-11 Months n = 64
Serotype 1	2.47 (2.09 to 2.92)	3.66 (2.98 to 4.50)
Serotype 3	2.65 (2.30 to 3.05)	1.71 (1.40 to 2.08)
Serotype 4	2.21 (1.82 to 2.68)	3.85 (3.12 to 4.76)
Serotype 5	3.82 (3.14 to 4.63)	4.56 (3.58 to 5.80)
Serotype 6A	2.23 (1.71 to 2.91)	4.30 (3.28 to 5.65)
Serotype 6B	3.03 (2.41 to 3.82)	4.17 (3.25 to 5.36)
Serotype 7F	5.16 (4.27 to 6.23)	6.42 (5.25 to 7.85)
Serotype 9V	2.61 (2.09 to 3.26)	3.59 (2.86 to 4.51)

Population analysed: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.

Primary outcome: GMC of Serotype-specific IgG - Schedule B: 12-23 Months

Time frame: 30 days post last vaccination. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	V114, Schedule B: Participants 12-23 Months n = 62	Prevnar 13®, Schedule B: Participants 12-23 Months n = 64
Serotype 1	3.83 (3.07 to 4.77)	4.20 (3.30 to 5.34)
Serotype 3	2.96 (2.44 to 3.58)	1.68 (1.29 to 2.20)
Serotype 4	3.46 (2.67 to 4.50)	4.89 (3.76 to 6.36)
Serotype 5	3.39 (2.65 to 4.34)	3.12 (2.52 to 3.88)
Serotype 6A	2.05 (1.30 to 3.23)	3.73 (2.64 to 5.29)
Serotype 6B	2.69 (1.70 to 4.25)	2.87 (1.92 to 4.30)
Serotype 7F	4.80 (3.63 to 6.34)	5.42 (4.30 to 6.82)
Serotype 9V	2.48 (1.97 to 3.11)	2.89 (2.21 to 3.78)

Population analysed: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.

Primary outcome: GMC of Serotype-specific IgG - Schedule C: 2-17 Years

Time frame: 30 days post vaccination. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	V114, Schedule C: Participants 2-17 Years n = 177	Prevnar 13®, Schedule C: Participants 2-17 Years n = 175
Serotype 1	3.00 (2.60 to 3.46)	3.99 (3.48 to 4.58)
Serotype 3	1.37 (1.19 to 1.58)	1.03 (0.88 to 1.21)
Serotype 4	2.53 (2.17 to 2.96)	5.22 (4.52 to 6.03)
Serotype 5	3.43 (2.89 to 4.07)	4.24 (3.46 to 5.20)
Serotype 6A	9.03 (7.07 to 11.53)	8.81 (6.96 to 11.14)
Serotype 6B	13.55 (10.52 to 17.46)	10.51 (8.01 to 13.78)
Serotype 7F	4.03 (3.46 to 4.70)	4.63 (3.92 to 5.46)
Serotype 9V	3.60 (3.06 to 4.24)	4.35 (3.65 to 5.20)

Population analysed: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.

Primary outcome: Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months

Time frame: Up to 14 days post any vaccination. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114, Schedule A: Participants 7-11 Months n = 64	Prevnar 13®, Schedule A: Participants 7-11 Months n = 64
Redness/Erythema	28.1 (17.6 to 40.8)	34.4 (22.9 to 47.3)
Hardness/Induration	17.2 (8.9 to 28.7)	14.1 (6.6 to 25.0)
Pain	18.8 (10.1 to 30.5)	7.8 (2.6 to 17.3)
Swelling	18.8 (10.1 to 30.5)	15.6 (7.8 to 26.9)

Population analysed: The analysis population included all randomized participants who received at least 1 dose of study intervention.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114 (7-11 Months)	7 of 64 (10.9%)	44 of 64 (68.8%)	0 of 64
Prevnar (7-11 Months)	5 of 64 (7.8%)	47 of 64 (73.4%)	0 of 64
V114 (12-23 Months)	4 of 62 (6.5%)	46 of 62 (74.2%)	0 of 62
Prevnar (12-23 Months)	4 of 64 (6.3%)	36 of 64 (56.3%)	0 of 64
V114 (2-17 Years)	4 of 177 (2.3%)	125 of 177 (70.6%)	0 of 177
Prevnar (2-17 Years)	4 of 175 (2.3%)	125 of 175 (71.4%)	0 of 175

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36150974Banniettis N, Wysocki J, Szenborn L, Phongsamart W, Pitisuttithum P, Ramet M, Richmond P, Shi Y, Dagan R, Good L, Papa M, Lupinacci R, McFetridge R, Tamms G, Churchill C, Musey L, Bickham K; V114-024 PNEU-PLAN study group. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325. doi: 10.1016/j.vaccine.2022.09.003. Epub 2022 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.

Study Director study director

Merck Sharp & Dohme LLC

26 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114 and Prevnar 13® in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 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 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Finland, Poland, Russia, Thailand, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months (time frame: 30 days post last vaccination). The study lists 12 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 NCT03885934, 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 13 Jan 2023.