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A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V114
Prevnar 13™
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

42 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
  • Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
  • Have 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.

Exclusion Criteria:

  • History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing 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
  • Known or history of functional or anatomic asplenia
  • Failure to thrive based on the clinical judgment of the investigator
  • Known coagulation disorder contraindicating intramuscular vaccination
  • 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)
  • Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Received a dose of any pneumococcal vaccine prior to study entry
  • Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
  • 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.
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
  • Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.

Sites / Locations

  • Premier Health Research Center, LLC ( Site 0005)
  • Beach Pediatrics ( Site 0040)
  • Khruz Biotechnology Research Institute ( Site 0006)
  • Kaiser Permanente - San Jose ( Site 0036)
  • Kaiser Permanente - Santa Clara ( Site 0027)
  • Children's Research, LLC ( Site 0025)
  • Advanced Research For Health Improvement LLC ( Site 0030)
  • Pediatric Partners, P.A. ( Site 0010)
  • Novak Center for Childrens Health ( Site 0033)
  • Medpharmics, LLC ( Site 0037)
  • Child Health Care Associates ( Site 0024)
  • Primedical Clinical Research ( Site 0035)
  • Allegheny Health & Wellness Pavilion West ( Site 0034)
  • CCP- Kid's Way ( Site 0008)
  • Thomas Jefferson University ( Site 0029)
  • Medical Research South, LLC ( Site 0013)
  • Pediatric Associates [Houston, TX] ( Site 0039)
  • University of Texas Medical Branch ( Site 0018)
  • Tanner Clinic ( Site 0009)
  • Wee Care Pediatrics ( Site 0031)
  • Wee Care Pediatrics ( Site 0020)
  • University of Wisconsin American Family Children's Hospital ( Site 0023)
  • Monash Children s Hospital ( Site 0093)
  • Perth Children s Hospital ( Site 0092)
  • Children, Youth and Woman's Health Service ( Site 0094)
  • Alberta Children s Hospital ( Site 0048)
  • Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046)
  • IWK Health Centre [Halifax, Canada] ( Site 0043)
  • Hamilton Medical Research Group ( Site 0049)
  • Medicor Research Inc. ( Site 0041)
  • CHU Sainte Justine ( Site 0047)
  • McGill University Health Centre - Vaccine Study Centre ( Site 0045)
  • CHUQ - Unite de Recherche en Sante Publique ( Site 0042)
  • Espoon rokotetutkimuskeskus ( Site 0066)
  • Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)
  • Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)
  • Jarvenpaan rokotetutkimuskeskus ( Site 0067)
  • Kokkolan rokotetutkimusklinikka ( Site 0071)
  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)
  • Porin Rokotetutkimusklinikka ( Site 0069)
  • Seinajoki Vaccine Research Center ( Site 0070)
  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)
  • Turun rokotetutkimuskeskus ( Site 0068)
  • Kinderarztpraxis ( Site 0124)
  • Kinderarztpraxis ( Site 0123)
  • Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085)
  • Kinderarztpraxis ( Site 0081)
  • Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122)
  • Kinderarztpraxis ( Site 0080)
  • Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091)
  • Kinderarztpraxis ( Site 0084)
  • Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)
  • Soroka University Medical Center ( Site 0077)
  • Soroka University Medical Center - Ramot Family health center ( Site 0078)
  • Rambam Medical Center ( Site 0076)
  • Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138)
  • Rambam Medical Center- Neve David Family Health Center ( Site 0139)
  • Soroka Medical Center_ Hura Family health center ( Site 0137)
  • Soroka University Medical Center - Rahat Family health center ( Site 0079)
  • Klinik Kesihatan Greentown ( Site 0132)
  • Sarawak General Hospital ( Site 0107)
  • Hospital Sibu ( Site 0111)
  • Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108)
  • Klinik Kesihatan Pandamaran ( Site 0110)
  • Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057)
  • Instituto de Investigacion Nutricional ( Site 0058)
  • Clinica Peruano Americana S.A. ( Site 0061)
  • Taichung Veterans General Hospital ( Site 0100)
  • National Taiwan University Hospital ( Site 0097)
  • Mackay Memorial Hospital ( Site 0099)
  • Chang Gung Medical Foundation. Linkou ( Site 0098)
  • Chulalongkorn University ( Site 0102)
  • Siriraj Hospital ( Site 0101)
  • Maharaj Nakorn Chiang Mai Hospital ( Site 0103)
  • Prince of Songkla University, Faculty of Medicine ( Site 0105)
  • Srinagarind Hospital. Khon Kaen University ( Site 0104)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V114

Prevnar 13™

Arm Description

Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Outcomes

Primary Outcome Measures

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.
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).
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.

Secondary Outcome Measures

Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
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 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
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 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
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 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)
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 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. This endpoint was part of a Premature Infant Immunogenicity Substudy.

Full Information

First Posted
September 28, 2018
Last Updated
July 20, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03692871
Brief Title
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.

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
2409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V114
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Arm Title
Prevnar 13™
Arm Type
Active Comparator
Arm Description
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Intervention Type
Biological
Intervention Name(s)
V114
Other Intervention Name(s)
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Intervention Description
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Intervention Type
Biological
Intervention Name(s)
Prevnar 13™
Intervention Description
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose
Primary Outcome Measure Information:
Title
Percentage of Participants With a Solicited Injection-site Adverse Event
Description
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.
Time Frame
Up to Day 14 after each study vaccination
Title
Percentage of Participants With a Solicited Systemic Adverse Event
Description
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).
Time Frame
Up to Day 14 after each study vaccination
Title
Percentage of Participants With a Vaccine-related Serious Adverse Event
Description
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.
Time Frame
Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
Secondary Outcome Measure Information:
Title
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
Description
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 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time Frame
30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
Title
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
Description
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 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time Frame
Before Vaccination 4 (10-13 months after Vaccination 1)
Title
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
Description
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 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time Frame
30 days after Vaccination 4 (11-14 months after Vaccination 1)
Title
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)
Description
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 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. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time Frame
30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent Have 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. Exclusion Criteria: History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing 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 Known or history of functional or anatomic asplenia Failure to thrive based on the clinical judgment of the investigator Known coagulation disorder contraindicating intramuscular vaccination 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) Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders Received a dose of any pneumococcal vaccine prior to study entry Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine 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. Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
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
Premier Health Research Center, LLC ( Site 0005)
City
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
Beach Pediatrics ( Site 0040)
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Khruz Biotechnology Research Institute ( Site 0006)
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Kaiser Permanente - San Jose ( Site 0036)
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente - Santa Clara ( Site 0027)
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Children's Research, LLC ( Site 0025)
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Advanced Research For Health Improvement LLC ( Site 0030)
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Pediatric Partners, P.A. ( Site 0010)
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Novak Center for Childrens Health ( Site 0033)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Medpharmics, LLC ( Site 0037)
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Child Health Care Associates ( Site 0024)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Primedical Clinical Research ( Site 0035)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Allegheny Health & Wellness Pavilion West ( Site 0034)
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
CCP- Kid's Way ( Site 0008)
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
Thomas Jefferson University ( Site 0029)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical Research South, LLC ( Site 0013)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Pediatric Associates [Houston, TX] ( Site 0039)
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
University of Texas Medical Branch ( Site 0018)
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Tanner Clinic ( Site 0009)
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wee Care Pediatrics ( Site 0031)
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wee Care Pediatrics ( Site 0020)
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
University of Wisconsin American Family Children's Hospital ( Site 0023)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Monash Children s Hospital ( Site 0093)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Perth Children s Hospital ( Site 0092)
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Children, Youth and Woman's Health Service ( Site 0094)
City
North Adelaide
ZIP/Postal Code
5087
Country
Australia
Facility Name
Alberta Children s Hospital ( Site 0048)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4H4
Country
Canada
Facility Name
IWK Health Centre [Halifax, Canada] ( Site 0043)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Hamilton Medical Research Group ( Site 0049)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Medicor Research Inc. ( Site 0041)
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1Y8
Country
Canada
Facility Name
CHU Sainte Justine ( Site 0047)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
McGill University Health Centre - Vaccine Study Centre ( Site 0045)
City
Pierrefonds
State/Province
Quebec
ZIP/Postal Code
H9H 4Y6
Country
Canada
Facility Name
CHUQ - Unite de Recherche en Sante Publique ( Site 0042)
City
Quebec
ZIP/Postal Code
G1E 7G9
Country
Canada
Facility Name
Espoon rokotetutkimuskeskus ( Site 0066)
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Jarvenpaan rokotetutkimuskeskus ( Site 0067)
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
Kokkolan rokotetutkimusklinikka ( Site 0071)
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Porin Rokotetutkimusklinikka ( Site 0069)
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Seinajoki Vaccine Research Center ( Site 0070)
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Turun rokotetutkimuskeskus ( Site 0068)
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Kinderarztpraxis ( Site 0124)
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0123)
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Facility Name
Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085)
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0081)
City
Huerth
ZIP/Postal Code
50354
Country
Germany
Facility Name
Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122)
City
Lauffen
ZIP/Postal Code
74348
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0080)
City
Moenchengladbach
ZIP/Postal Code
41236
Country
Germany
Facility Name
Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091)
City
Munchengladbach
ZIP/Postal Code
41236
Country
Germany
Facility Name
Kinderarztpraxis ( Site 0084)
City
Schoenau
ZIP/Postal Code
83471
Country
Germany
Facility Name
Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)
City
Wolfsburg
ZIP/Postal Code
38448
Country
Germany
Facility Name
Soroka University Medical Center ( Site 0077)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Soroka University Medical Center - Ramot Family health center ( Site 0078)
City
Beer-Sheva
ZIP/Postal Code
8471844
Country
Israel
Facility Name
Rambam Medical Center ( Site 0076)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138)
City
Haifa
ZIP/Postal Code
3515427
Country
Israel
Facility Name
Rambam Medical Center- Neve David Family Health Center ( Site 0139)
City
Haifa
ZIP/Postal Code
3542129
Country
Israel
Facility Name
Soroka Medical Center_ Hura Family health center ( Site 0137)
City
Hura
ZIP/Postal Code
8573000
Country
Israel
Facility Name
Soroka University Medical Center - Rahat Family health center ( Site 0079)
City
Rahat
ZIP/Postal Code
8535700
Country
Israel
Facility Name
Klinik Kesihatan Greentown ( Site 0132)
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Sarawak General Hospital ( Site 0107)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Sibu ( Site 0111)
City
Sibu
State/Province
Sarawak
ZIP/Postal Code
96000
Country
Malaysia
Facility Name
Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Klinik Kesihatan Pandamaran ( Site 0110)
City
Pelabuhan Klang
ZIP/Postal Code
42000
Country
Malaysia
Facility Name
Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057)
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Instituto de Investigacion Nutricional ( Site 0058)
City
Lima
ZIP/Postal Code
15416
Country
Peru
Facility Name
Clinica Peruano Americana S.A. ( Site 0061)
City
Trujillo
ZIP/Postal Code
13011
Country
Peru
Facility Name
Taichung Veterans General Hospital ( Site 0100)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0097)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Mackay Memorial Hospital ( Site 0099)
City
Taipei
ZIP/Postal Code
10491
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0098)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn University ( Site 0102)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Siriraj Hospital ( Site 0101)
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital ( Site 0103)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Prince of Songkla University, Faculty of Medicine ( Site 0105)
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Srinagarind Hospital. Khon Kaen University ( Site 0104)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

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
37309607
Citation
Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.
Results Reference
result

Learn more about this trial

A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

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