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Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
V114
PCV13
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

2 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Japanese male or female

Exclusion Criteria:

  • Has a history of invasive pneumococcal disease (IPD)
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
  • Has a known or suspected impairment of immunological function
  • Has a history of congenital or acquired immunodeficiency
  • 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 a history of autoimmune disease
  • Has a known neurologic or cognitive behavioral disorder
  • Has received a dose of any pneumococcal vaccine prior to study entry
  • Has received a blood transfusion or blood products, including immunoglobulins

Sites / Locations

  • Morinaga Maternity Clinic ( Site 3345)
  • Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
  • Kyoritsu Narashinodai Hospital ( Site 3332)
  • Sotobo Children's Clinic ( Site 3323)
  • Yokoyama Children's Clinic ( Site 3309)
  • Chugoku Rosai Hospital ( Site 3340)
  • Tsuchiura Kyodo General Hospital ( Site 3327)
  • Kagoshima Children's Hospital ( Site 3342)
  • Kawasaki Municipal Hospital ( Site 3302)
  • National Hospital Organization Sagamihara National Hospital ( Site 3303)
  • JOHAS Yokohama Rosai Hospital ( Site 3343)
  • National Hospital Organization Mie Chuo Medical Center ( Site 3308)
  • National Hospital Organization Sendai Medical Center ( Site 3311)
  • Ina Central Hospital ( Site 3346)
  • Aizawa Hospital ( Site 3313)
  • Taniguchi Hospital ( Site 3310)
  • Medical corporation Waffle GunGunkids Clinic ( Site 3329)
  • Suita Municipal Hospital ( Site 3338)
  • Takatsuki General Hospital ( Site 3318)
  • Aiwa Hospital ( Site 3336)
  • Saiseikai Kawaguchi General Hospital ( Site 3304)
  • Hara Children's Clinic ( Site 3339)
  • National Hospital Organization Saitama Hospital ( Site 3312)
  • Saiseikai Shiga Hospital ( Site 3349)
  • Kobayashi Pediatric Clinic ( Site 3301)
  • Saiwai Kodomo Clinic ( Site 3331)
  • Nishida Kodomo Clinic ( Site 3306)
  • Fukui Aiiku Hospital ( Site 3315)
  • Fukui-ken Saiseikai Hospital ( Site 3314)
  • Shindo Children's Clinic ( Site 3325)
  • Kurokawa Michiko Pediatric Clinic ( Site 3319)
  • Shimomura Pediatrics Clinic ( Site 3320)
  • INAMITSU Children's Clinic ( Site 3321)
  • Nagamine Soyokaze Clinic ( Site 3348)
  • Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)
  • Saiseikai Noe Hospital ( Site 3330)
  • Kubota Children's Clinic ( Site 3334)
  • Sano Kids Clinic ( Site 3341)
  • Aizenbashi Hospital ( Site 3317)
  • Japanese Red Cross Shizuoka Hospital ( Site 3322)
  • Shizuoka City Shimizu Hospital ( Site 3347)
  • Hosaka Children's Clinic ( Site 3307)
  • The Fraternity Memorial Hospital ( Site 3333)
  • Okawa Children & Family Clinic ( Site 3305)
  • Toyama City Hospital ( Site 3328)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V114

Pneumococcal 13-valent Conjugate Vaccine (PCV13)

Arm Description

Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.

Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.

Outcomes

Primary Outcome Measures

Percentage of Participants With Solicited Injection-Site Adverse Events
An adverse event (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. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Percentage of Participants With Solicited Systemic Adverse Events
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. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
Percentage of Participants With Vaccine-Related Serious Adverse Events
A serious adverse event (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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.

Secondary Outcome Measures

GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.

Full Information

First Posted
May 11, 2020
Last Updated
July 20, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04384107
Brief Title
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
694 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V114
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Arm Title
Pneumococcal 13-valent Conjugate Vaccine (PCV13)
Arm Type
Active Comparator
Arm Description
Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Intervention Type
Biological
Intervention Name(s)
V114
Other Intervention Name(s)
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Intervention Description
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.
Intervention Type
Biological
Intervention Name(s)
PCV13
Other Intervention Name(s)
Prevnar 13™
Intervention Description
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
Primary Outcome Measure Information:
Title
Percentage of Participants With Solicited Injection-Site Adverse Events
Description
An adverse event (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. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Time Frame
Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Title
Percentage of Participants With Solicited Systemic Adverse Events
Description
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. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
Time Frame
Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Title
Percentage of Participants With Vaccine-Related Serious Adverse Events
Description
A serious adverse event (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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Time Frame
~1 month after Dose 4, up to a total of 14 months
Title
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
Description
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Time Frame
30 Days after Dose 3, up to a total of 11 months
Title
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
Description
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.
Time Frame
30 Days after Dose 3, up to a total of 11 months
Secondary Outcome Measure Information:
Title
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3
Description
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.
Time Frame
30 days after Dose 3, up to a total of 11 months
Title
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4
Description
The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Time Frame
30 Days after Dose 4, up to a total of 14 months
Title
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4
Description
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.
Time Frame
30 Days after Dose 4, up to a total of 14 months
Title
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3
Description
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Time Frame
30 Days after Dose 3, up to a total of 11 months
Title
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4
Description
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Time Frame
30 Days after Dose 4, up to a total of 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Japanese male or female Exclusion Criteria: Has a history of invasive pneumococcal disease (IPD) Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine Has a known or suspected impairment of immunological function Has a history of congenital or acquired immunodeficiency 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 a history of autoimmune disease Has a known neurologic or cognitive behavioral disorder Has received a dose of any pneumococcal vaccine prior to study entry Has received a blood transfusion or blood products, including immunoglobulins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Morinaga Maternity Clinic ( Site 3345)
City
Kasugai
State/Province
Aichi
ZIP/Postal Code
486-0836
Country
Japan
Facility Name
Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Kyoritsu Narashinodai Hospital ( Site 3332)
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
274-0063
Country
Japan
Facility Name
Sotobo Children's Clinic ( Site 3323)
City
Isumi
State/Province
Chiba
ZIP/Postal Code
299-4503
Country
Japan
Facility Name
Yokoyama Children's Clinic ( Site 3309)
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0801
Country
Japan
Facility Name
Chugoku Rosai Hospital ( Site 3340)
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0193
Country
Japan
Facility Name
Tsuchiura Kyodo General Hospital ( Site 3327)
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0028
Country
Japan
Facility Name
Kagoshima Children's Hospital ( Site 3342)
City
Hioki
State/Province
Kagoshima
ZIP/Postal Code
899-2503
Country
Japan
Facility Name
Kawasaki Municipal Hospital ( Site 3302)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0013
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital ( Site 3303)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
JOHAS Yokohama Rosai Hospital ( Site 3343)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
National Hospital Organization Mie Chuo Medical Center ( Site 3308)
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-1101
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center ( Site 3311)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Ina Central Hospital ( Site 3346)
City
Ina
State/Province
Nagano
ZIP/Postal Code
396-8555
Country
Japan
Facility Name
Aizawa Hospital ( Site 3313)
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8510
Country
Japan
Facility Name
Taniguchi Hospital ( Site 3310)
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-0043
Country
Japan
Facility Name
Medical corporation Waffle GunGunkids Clinic ( Site 3329)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8023
Country
Japan
Facility Name
Suita Municipal Hospital ( Site 3338)
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-8567
Country
Japan
Facility Name
Takatsuki General Hospital ( Site 3318)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1192
Country
Japan
Facility Name
Aiwa Hospital ( Site 3336)
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-0001
Country
Japan
Facility Name
Saiseikai Kawaguchi General Hospital ( Site 3304)
City
Kawaguchi
State/Province
Saitama
ZIP/Postal Code
332-8558
Country
Japan
Facility Name
Hara Children's Clinic ( Site 3339)
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
Facility Name
National Hospital Organization Saitama Hospital ( Site 3312)
City
Wako
State/Province
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Facility Name
Saiseikai Shiga Hospital ( Site 3349)
City
Ritto
State/Province
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Kobayashi Pediatric Clinic ( Site 3301)
City
Fujieda
State/Province
Shizuoka
ZIP/Postal Code
426-0067
Country
Japan
Facility Name
Saiwai Kodomo Clinic ( Site 3331)
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0002
Country
Japan
Facility Name
Nishida Kodomo Clinic ( Site 3306)
City
Tama
State/Province
Tokyo
ZIP/Postal Code
206-0025
Country
Japan
Facility Name
Fukui Aiiku Hospital ( Site 3315)
City
Fukui
ZIP/Postal Code
910-0833
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital ( Site 3314)
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Shindo Children's Clinic ( Site 3325)
City
Fukuoka
ZIP/Postal Code
814-0121
Country
Japan
Facility Name
Kurokawa Michiko Pediatric Clinic ( Site 3319)
City
Fukuoka
ZIP/Postal Code
815-0033
Country
Japan
Facility Name
Shimomura Pediatrics Clinic ( Site 3320)
City
Fukuoka
ZIP/Postal Code
819-0002
Country
Japan
Facility Name
INAMITSU Children's Clinic ( Site 3321)
City
Fukuoka
ZIP/Postal Code
819-0041
Country
Japan
Facility Name
Nagamine Soyokaze Clinic ( Site 3348)
City
Kumamoto
ZIP/Postal Code
862-0920
Country
Japan
Facility Name
Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)
City
Nagano
ZIP/Postal Code
388-8004
Country
Japan
Facility Name
Saiseikai Noe Hospital ( Site 3330)
City
Osaka
ZIP/Postal Code
536-0001
Country
Japan
Facility Name
Kubota Children's Clinic ( Site 3334)
City
Osaka
ZIP/Postal Code
544-0033
Country
Japan
Facility Name
Sano Kids Clinic ( Site 3341)
City
Osaka
ZIP/Postal Code
553-0001
Country
Japan
Facility Name
Aizenbashi Hospital ( Site 3317)
City
Osaka
ZIP/Postal Code
556-0005
Country
Japan
Facility Name
Japanese Red Cross Shizuoka Hospital ( Site 3322)
City
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan
Facility Name
Shizuoka City Shimizu Hospital ( Site 3347)
City
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
Facility Name
Hosaka Children's Clinic ( Site 3307)
City
Tokyo
ZIP/Postal Code
112-0001
Country
Japan
Facility Name
The Fraternity Memorial Hospital ( Site 3333)
City
Tokyo
ZIP/Postal Code
130-8587
Country
Japan
Facility Name
Okawa Children & Family Clinic ( Site 3305)
City
Tokyo
ZIP/Postal Code
146-0095
Country
Japan
Facility Name
Toyama City Hospital ( Site 3328)
City
Toyama
ZIP/Postal Code
939-8511
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
37344262
Citation
Suzuki H, Fujita H, Iwai K, Kuroki H, Taniyama K, Shizuya T, Kishino H, Igarashi R, Shirakawa M, Sawata M. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033). Vaccine. 2023 Jul 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19.
Results Reference
result

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Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

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