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Pneumococcal InfectionsPhase 3PNEU-PED-EU-2NCT04016714

Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)

A Phase 3 study testing V114, Prevenar 13™ and Vaxelis™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 24 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 clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE)… Read more about this study

Who is it for?
Ages 70 to 111 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infections
What is being tested?
V114, Prevenar 13™ and Vaxelis™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,191 participants
Where
24 sitesin 5 countries
Study dates
28 Aug 2019to 29 Oct 2021
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 70 to 111 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent.
  • 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

  • Was born prior to 37 weeks of gestation.
  • Has a history of invasive pneumococcal disease (IPD) or known history of other culture positive pneumococcal disease.
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid containing vaccine.
  • Has any contraindication to the concomitant study vaccines being administered in the study.
  • Has a known or suspected impairment of immunological function.
  • Has a history of congenital or acquired immunodeficiency.
Show all 20Show fewer
  • Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection.
  • Has, or his/her mother has, a documented hepatitis B surface antigen - positive test.
  • Has 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 a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
  • Has received a dose of any pneumococcal vaccine prior to study entry.
  • Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry.
  • Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry.
  • Has received a blood transfusion or blood products, including immunoglobulins.
  • Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case by-case basis for approval by the Sponsor.
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
  • Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

Finland10 sites

  • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0024)

    Espoo, Uusimaa, 02230

  • Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0022)

    Helsinki, Uusimaa, 00100

  • Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0023)

    Helsinki, Uusimaa, 00930

  • Jarvenpaan rokotetutkimuskeskus ( Site 0025)

    Jarvenpaa, Uusimaa, 04400

  • Kokkolan rokotetutkimusklinikka ( Site 0029)

    Kokkola, Keski-Pohjanmaa, 67100

  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0030)

    Oulu, North Ostrobothnia, 90220

  • Porin rokotetutkimusklinikka ( Site 0027)

    Pori, Satakunta, 28100

  • Seinajoki Vaccine Research Center ( Site 0028)

    Seinäjoki, South Ostrobothnia, 60100

  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0021)

    Tampere, Pirkanmaa, 33100

  • Turun rokotetutkimuskeskus ( Site 0026)

    Turku, Southwest Finland, 20520

Other trials in Finland

Denmark6 sites

  • Aalborg Universitetshospital ( Site 0005)

    Aalborg, North Denmark, 9000

  • Aarhus Universitetshosp. Skejby ( Site 0002)

    Aarhus, Central Jutland, 8200

  • Regionshospitalet Herning Hospitalsenheden Vest ( Site 0006)

    Herning, Central Jutland, 7400

  • Sygehus Vendsyssel Hjoerring ( Site 0004)

    Hjørring, North Denmark, 9800

  • Hvidovre Hospital ( Site 0003)

    Hvidovre, Capital Region, 2650

  • Odense Universitetshospital ( Site 0001)

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Italy4 sites

  • A.O. Policlinico Consorziale di Bari ( Site 0044)

    Bari, 70124

  • A.O.U. Riuniti Di Foggia - Igiene Universitaria ( Site 0046)

    Foggia, 71121

  • IRCCS Ospedale Policlinico San Martino ( Site 0042)

    Genova, 16132

  • Policlinico Universitario Agostino Gemelli ( Site 0048)

    Rome, Roma, 00168

Other trials in Italy

Norway3 sites

  • Oslo Universitetssykehus HF Ulleval Sykehus ( Site 0061)

    Oslo, 0450

  • Stavanger universitetssykehus ( Site 0062)

    Stavanger, Rogaland, 4011

  • Sykehuset i Vestfold ( Site 0063)

    Tønsberg, Vestfold, 3103

Other trials in Norway

Sweden1 site

  • Norrlands Universitetssjukhus ( Site 0100)

    Umeå, Vasterbottens Lan [se-24], 901 85

Other trials in Sweden

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.

The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.

Being tested
V114, Prevenar 13™, Vaxelis™, M-M-R®II, VARIVAX™
Medical subject headings
Pneumococcal Infections

What participants receive

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

  • V114Drug

    Also called VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.

  • Prevenar 13™Drug

    Also called Prevnar 13™

    13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.

  • Vaxelis™Drug

    Intramuscular 0.5 mL single dose

  • M-M-R®IIDrug

    Also called Measles, Mumps, and Rubella Virus Vaccine Live

    Subcutaneous 0.5 mL single dose

  • VARIVAX™Drug

    Also called Varicella Vaccine Live

    Subcutaneous 0.5 mL single dose

Study groups in NCT04016714
Study groupRoleWhat they receive
V114ExperimentalParticipants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants will also receive other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who will receive a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Receives: Drug: V114; Drug: Vaxelis™; Drug: M-M-R®II; Drug: VARIVAX™
Prevenar 13™Active comparatorParticipants will receive a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants will also receive other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who will receive a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Receives: Drug: Prevenar 13™; Drug: Vaxelis™; Drug: M-M-R®II; Drug: VARIVAX™

What is being measured

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

  1. Percentage of Participants With a Solicited Injection-site Adverse Event

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.

    Measured: Day 1 to Day 14 after each vaccination

  2. Percentage of Participants With a Solicited Systemic Adverse Event

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).

    Measured: Day 1 to Day 14 after each vaccination

  3. Percentage of Participants With a Vaccine-related 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.

    Measured: Up to approximately 6 months after Dose 3 (up to approximately 16 months)

  4. Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3

    The geometric mean concentration (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 Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay.

    Measured: 30 days after Dose 3

  5. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3

    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 Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.

    Measured: 30 days after Dose 3

Secondary outcomes (5)

  1. Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3

    Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3.

    Measured: 30 days after Dose 3

  2. Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2

    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 Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay.

    Measured: 30 days after Dose 2

  3. GMC of Serotype-specific IgG 30 Days After Dose 2

    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 Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay.

    Measured: 30 days after Dose 2

  4. Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3

    OPA for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was measured using a multiplex opsonophagocytic assay (MOPA).

    Measured: 30 days after Dose 3

  5. Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3

    Sera from participants was used to measure GMT of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA.

    Measured: 30 days after Dose 3

Timeline

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

  1. First posted11 Jul 2019
  2. Study start28 Aug 2019
  3. Primary completion29 Oct 2021
  4. Study completion29 Oct 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04016714
Sponsor's protocol ID
V114-026
Other IDs
V114-026, 2018-003788-70, 2018
Acronym
PNEU-PED-EU-2
Status last verified
May 2023
First submitted
10 Jul 2019
Last updated
6 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Benfield T, Ramet M, Valentini P, Seppa I, Dagan R, Richmond P, Mercer S, Churchill C, Lupinacci R, McFetridge R, Park J, Wittke F, Banniettis N, Musey L, Bickham K, Kaminski J. Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants: A phase III study (PNEU-PED-EU-2). Vaccine. 2023 Apr 6;41(15):2456-2465. doi: 10.1016/j.vaccine.2023.02.041. Epub 2023 Feb 24.

    PubMed 36841723

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114, Prevenar 13™ and Vaxelis™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 24 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 2 inclusion and 20 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Finland, Denmark, Italy, Norway, Sweden. 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 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Percentage of Participants With a Solicited Injection-site Adverse Event (time frame: Day 1 to Day 14 after each vaccination). The study lists 5 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 NCT04016714, 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 6 May 2023.

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