Pneumococcal InfectionsPhase 1NCT03848065

Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)

A Phase 1 study testing V114, Pneumococcal 13-valent Conjugate Vaccine (PCV13) and Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV) in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 14 sites in Japan.

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 to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age). Read more about this study

Who is it for?: Ages 3 to 3 monthsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114, Pneumococcal 13-valent Conjugate Vaccine (PCV13) and Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 14 sitesJapan
Study dates: 2 Apr 2019to 24 Jun 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

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

Ages 3 to 3 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of age), at the time of obtaining 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

Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
Has a known hypersensitivity to vaccines, any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis, inactivated polio vaccine (DTaP-IPV) being administered in the study (Refer to approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).
Has a recent febrile illness (axillary temperature ≥37.5°C) occurring within 72 hours prior to receipt of study vaccine.
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 hepatitis B surface antigen - positive test.
Has a known functional or anatomic asplenia.
Has failure to thrive based on the clinical judgement of the investigator.
Has thrombocytopenia or a known coagulation disorder contraindicating intramuscular vaccination.
Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Bechet'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 and/or DTaP-IPV vaccine (or vaccine containing any DTaP-IPV component) prior to study entry.
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/d for persons weighing > 10 kg) for ≥ 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization, has received systemic corticosteroids within 14 days prior to the first dose of study vaccine at randomization, and is expected to require systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d for persons weighing > 10 kg) for ≥ 14 consecutive days within 14 days prior to or 30 days after each vaccination during conduct of the study.(Topical, ophthalmic and inhaled steroids are permitted.)
Has received other licensed non-live vaccines within the 14 days before receipt of first dose of study vaccine.
Has received a licensed live virus vaccine within the 28 days before receipt of first dose of study vaccine.
Has received a blood transfusion or blood products, including immunoglobulins before receipt of first dose 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. 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. (Refer to the Vaccination Guideline in Japan). 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., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Japan14 sites

Hidaka Children's Clinic ( Site 2803)
Dazaifu, Fukuoka, 818-0134
Kobayashi Pediatric Clinic ( Site 2816)
Fujieda, Shizuoka, 426-0067
Fukui Aiiku Hospital ( Site 2809)
Fukui, 910-0833
Fukui-ken Saiseikai Hospital ( Site 2813)
Fukui, 918-8503
Isesaki Municipal Hospital ( Site 2806)
Isesaki, Gunma, 372-0817
Sotobo Children's Clinic ( Site 2807)
Isumi, Chiba, 299-4503
Kawasaki Municipal Hospital ( Site 2802)
Kawasaki, Kanagawa, 210-0013
Meitetsu Hospital ( Site 2805)
Nagoya, Aichi-ken, 451-8511
Kubota Children's Clinic ( Site 2815)
Osaka, 544-0033
Japanese Red Cross Shizuoka Hospital ( Site 2817)
Shizuoka, 420-0853
Suita Municipal Hospital ( Site 2801)
Suita, Osaka, 564-8567
Nishida Kodomo Clinic ( Site 2811)
Tama, Tokyo, 206-0025
Hosaka Children's Clinic ( Site 2814)
Tokyo, 112-0001
Yokosuka Kyosai Hospital ( Site 2804)
Yokosuka, Kanagawa, 238-8558

Other trials in Japan

About this study

Official title: A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).

Conditions: Pneumococcal Infections
Being tested: V114, Pneumococcal 13-valent Conjugate Vaccine (PCV13), Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
Keywords: Pneumococcal Vaccines
Medical subject headings: Pneumococcal Infections

What participants receive

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

V114Biological
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 (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
Pneumococcal 13-valent Conjugate Vaccine (PCV13)Biological
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.
Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)Biological
Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).

Study groups in NCT03848065
Study group	Role	What they receive
V114-SC	Experimental	Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of V114 on Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine [Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV) at the same time as V114-SC. Receives: Biological: V114; Biological: Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
V114-IM	Experimental	Infant participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as V114-IM. Receives: Biological: V114; Biological: Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
PCV13-SC	Active comparator	Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as PCV13-SC. Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine (PCV13); Biological: Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)

What is being measured

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

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Measured: Day 1 to Day 14 post each vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).
Measured: Day 1 to Day 14 post each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is an AE that 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. Relatedness of an SAE to the study vaccine was determined by the investigator.
Measured: Up to 4 weeks post vaccination 4 (~14.5 months)

Secondary outcomes (3)

Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
Serotype-specific pneumococcal IgG antibody was measured using pneumococcal electrochemiluminescence (PnECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Measured: One month post vaccination 3 (~3 months after Vaccination 1)
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
The anti-pneumococcal polysaccharide (PnPs) serotype-specific IgG Geometric Mean Concentrations (GMCs) were determined using an electrochemiluminescence assay.
Measured: 1 month post vaccination 3 (~3 months after Vaccination 1)
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
DTaP-IPV antibody titers were measured by neutralization assay (diphtheria toxin and poliovirus 1/2/3), particle agglutination assay (tetanus toxin) and enzyme-linked immunosorbent assay (ELISA) methodology (pertussis PT and pertussis FHA) 1 month post vaccination 3. Threshold values were: Diphtheria toxin level ≥0.1 IU/mL, Pertussis PT level ≥10 EU/mL, Pertussis FHA level ≥10 EU/mL, Tetanus toxin level ≥0.01 IU/mL, Neutralizing antibody (NA) titers of Polio virus types 1/2/3 ≥1:8.
Measured: 1 month post vaccination 3 (~3 months after Vaccination 1)

Timeline

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

2 Apr 201924 Jun 2020

First posted20 Feb 2019
Study start2 Apr 2019
Primary completion24 Jun 2020
Study completion24 Jun 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 (2)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03848065
Sponsor's protocol ID: V114-028
Other IDs: 194669
Status last verified: Jan 2025
First submitted: 19 Feb 2019
Last updated: 15 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Ishihara Y, Kuroki H, Hidaka H, Iwai K, Wan K, Shirakawa M, Sawata M. Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028). Hum Vaccin Immunother. 2023 Dec 31;19(1):2180973. doi: 10.1080/21645515.2023.2180973. Epub 2023 Mar 7.
PubMed 36882898
Wan K, Shirakawa M, Sawata M. Descriptive analysis of safety and immunogenicity profiles of a 15-valent pneumococcal conjugate vaccine between subcutaneous and intramuscular administration in a phase 1 study of healthy Japanese infants (V114-028). J Infect Chemother. 2025 Feb;31(2):102539. doi: 10.1016/j.jiac.2024.10.007. Epub 2024 Oct 9.
PubMed 39384037

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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
ClinicalTrials.gov ID: NCT03848065
Acronym / sponsor ID: V114-028
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Vaccines
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 2 Apr 2019 (actual)
Primary completion: 24 Jun 2020 (actual)
Study completion: 24 Jun 2020 (actual)
First posted: 20 Feb 2019 (actual)
Results: Posted 11 Oct 2023

Clinical summary

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

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
V114-SC	Experimental	Biological: V114, Biological: Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of V114 on Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine [Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV) at the same time as V114-SC.
V114-IM	Experimental	Biological: V114, Biological: Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)Infant participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as V114-IM.
PCV13-SC	Active comparator	Biological: Pneumococcal 13-valent Conjugate Vaccine (PCV13), Biological: Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as PCV13-SC.

Who may qualify

Ages: 3 to 3 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of age), at the time of obtaining 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.

Key exclusion criteria (20 listed)

Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
Has a known hypersensitivity to vaccines, any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis, inactivated polio vaccine (DTaP-IPV) being administered in the study (Refer to approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).
Has a recent febrile illness (axillary temperature ≥37.5°C) occurring within 72 hours prior to receipt of study vaccine.
Has a known or suspected impairment of immunological function.

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: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.	Biological	V114-IM, V114-SC
Pneumococcal 13-valent Conjugate Vaccine (PCV13)Also: 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.	Biological	PCV13-SC
Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).	Biological	PCV13-SC, V114-IM, V114-SC

Primary outcome

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Time frame: Day 1 to Day 14 post each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Percentage of Participants With a Solicited Systemic Adverse Event
Time frame: Day 1 to Day 14 post each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
Time frame: Up to 4 weeks post vaccination 4 (~14.5 months)
An SAE is an AE that 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. Relatedness of an SAE to the study vaccine was determined by the investigator.

3 secondary outcomes

Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
Time frame: One month post vaccination 3 (~3 months after Vaccination 1)
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
Time frame: 1 month post vaccination 3 (~3 months after Vaccination 1)
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
Time frame: 1 month post vaccination 3 (~3 months after Vaccination 1)

Results and safety

Results posted to the registry on 11 Oct 2023, 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-SC	44	44
V114-IM	45	44
PCV13-SC	44	42

Primary outcome: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Time frame: Day 1 to Day 14 post each vaccination. Number. Unit: Percentage of Participants

Measure	V114-SC n = 44	V114-IM n = 45	PCV13-SC n = 43
Injection Site Erythema (Redness)	100.0	82.2	95.3
Injection Site Induration (Hard Lump)	90.9	77.8	100.0
Injection Site Pain	38.6	28.9	41.9
Injection Site Swelling	86.4	73.3	88.4

V114-SC vs V114-IM: Difference in Percentages: 17.8 (95% CI 9.0 to 31.4), p = 0.004, Miettinen & Nurminen method
V114-SC vs PCV13-SC: Difference in Percentages: 4.7 (95% CI -3.7 to 15.5), p = 0.150, Miettinen & Nurminen method
V114-IM vs PCV13-SC: Difference in Percentages: -13.1 (95% CI -27.6 to 0.2), p = 0.054, Miettinen & Nurminen method

Population analysed: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.

Primary outcome: Percentage of Participants With a Solicited Systemic Adverse Event

Time frame: Day 1 to Day 14 post each vaccination. Number. Unit: Percentage of Participants

Measure	V114-SC n = 44	V114-IM n = 45	PCV13-SC n = 43
Decreased Appetite (Appetite Loss)	25.0	35.6	34.9
Somnolence (Drowsiness)	70.5	60.0	74.4
Irritability	81.8	71.1	74.4
Urticaria (Hives/Welts)	9.1	4.4	7.0

V114-SC vs V114-IM: Difference in Percentages: -10.6 (95% CI -29.1 to 8.7), p = 0.282, Miettinen & Nurminen method
V114-SC vs PCV13-SC: Difference in Percentages: -9.9 (95% CI -28.7 to 9.5), p = 0.317, Miettinen & Nurminen method
V114-IM vs PCV13-SC: Difference in Percentages: 0.7 (95% CI -19.2 to 20.4), p = 0.948, Miettinen & Nurminen method

Population analysed: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.

Primary outcome: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

Time frame: Up to 4 weeks post vaccination 4 (~14.5 months). Number. Unit: Percentage of Participants

Measure	V114-SC n = 44	V114-IM n = 45	PCV13-SC n = 43
Value	0.0	0.0	0.0

Population analysed: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs: up to 14 days post each vaccination SAEs and All-cause Mortality: up to 4 weeks post vaccination 4 (~14.5 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114-SC	1 of 44 (2.3%)	44 of 44 (100%)	0 of 44
V114-IM	3 of 45 (6.7%)	44 of 45 (97.8%)	1 of 45
PCV13-SC	2 of 43 (4.7%)	43 of 43 (100%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36882898Ishihara Y, Kuroki H, Hidaka H, Iwai K, Wan K, Shirakawa M, Sawata M. Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028). Hum Vaccin Immunother. 2023 Dec 31;19(1):2180973. doi: 10.1080/21645515.2023.2180973. Epub 2023 Mar 7.
Results publication: PubMed 39384037Wan K, Shirakawa M, Sawata M. Descriptive analysis of safety and immunogenicity profiles of a 15-valent pneumococcal conjugate vaccine between subcutaneous and intramuscular administration in a phase 1 study of healthy Japanese infants (V114-028). J Infect Chemother. 2025 Feb;31(2):102539. doi: 10.1016/j.jiac.2024.10.007. Epub 2024 Oct 9.
Merck Clinical Trials InformationLink provided by the sponsor.
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

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2023). 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 (AE) (time frame: Day 1 to Day 14 post each vaccination). The study lists 3 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 NCT03848065, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.