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A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

Primary Purpose

Pneumococcal Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Prevnar 13™

V114

RotaTeq™

Pentacel™

RECOMBIVAX HB™

HIBERIX™

M-M-R™ II

VARIVAX™

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:

Is Healthy, based on clinical judgment of the investigator
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.

Exclusion Criteria:

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 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
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 judgment of the investigator
Has a known coagulation 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 rotavirus vaccine 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
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 (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Sites / Locations

Alabama Clinical Therapeutics ( Site 0015)
Southeastern Pediatric Associates, P.A. ( Site 0002)
Children's Clinic of Jonesboro, PA ( Site 0022)
Davita Medical Group ( Site 0012)
Suncoast Research Associates, LLC ( Site 0035)
Kentucky Pediatric/Adult Research Inc ( Site 0011)
Pediatric Associates of Fall River ( Site 0021)
Midwest Children's Health Research Institute, LLC ( Site 0024)
Midwest Children's Health Research Institute, LLC ( Site 0003)
Midwest Children's Health Research Institute, LLC ( Site 0004)
Midwest Children's Health Research Institute, LLC ( Site 0001)
Summerwood Pediatrics ( Site 0009)
University of Rochester Medical Center ( Site 0029)
SUNY Upstate Medical University ( Site 0008)
Piedmont Healthcare, PA ( Site 0025)
Coastal Pediatric Research ( Site 0006)
Parkside Pediatric ( Site 0007)
Holston Medical Group ( Site 0018)
Ventavia Research Group LLC ( Site 0017)
University of Texas Medical Branch ( Site 0023)
Wasatch Pediatrics-Cottonwood Office ( Site 0014)
Multicare ( Site 0019)
Cooperativa de Facultad Medica Sanacoop ( Site 0057)
Clinical Research of Puerto Rico ( Site 0050)
CAIMED Center - Ponce School of Medicine ( Site 0053)
San Juan Hospital ( Site 0056)
University of Puerto Rico ( Site 0051)
Srinagarind Hospital. Khon Kaen University ( Site 0093)
Chulalongkorn University ( Site 0092)
Siriaj Hospital ( Site 0091)
Maharaj Nakorn Chiang Mai Hospital ( Site 0090)
Hacettepe University Faculty of Medicine ( Site 0070)
Eskisehir Osmangazi University Faculty of Medicine ( Site 0071)
Ege University Medical Faculty Hospital ( Site 0072)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™

Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114

Group 3: Prevnar 13™-Prevnar 13™-V114-V114

Group 4: Prevnar 13™-V114-V114-V114

Group 5: V114-V114-V114-V114

Arm Description

Participants will receive a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.

Participants will receive a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.

Outcomes

Primary Outcome Measures

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

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to ~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.

Percentage of Participants With a Solicited Systemic AE

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to ~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.

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

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.

Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4

The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.

Secondary Outcome Measures

Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3

The concentration of anti-HBsAg was assessed using an enhanced chemiluminescence assay. The protocol-specified analysis of the percentage of participants with anti-HBsAg ≥10 mIU/mL at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, participants with anti-HBsAg ≥10 mIU/mL in Group 5 were compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Analysis of participants with anti-HBsAg ≥10 mIU/mL was not planned to be reported in Group 3 and Group 4, per protocol.

Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3

The GMT of anti-rotavirus IgA was assessed using a serum IgA enzyme linked immunosorbent assay. The protocol specified analysis of anti-rotavirus IgA GMT at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, GMT of anti-rotavirus IgA in Group 5 was compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Anti-rotavirus IgA GMT analysis was not planned to be reported in Group 3 and Group 4, per protocol.

GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3

The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, GMC of 15 IgG serotypes was assessed at 30 days post Vaccination 3.

Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3

The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3.

Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4

The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a PnECL assay. Per protocol, GMC of 13 IgG serotypes was analysed by vaccine dosing schedules (Groups 1, 5). Per protocol, 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified primary outcome analysis and reported earlier in the record.

Full Information

NCT ID

NCT03620162

First Posted

August 3, 2018

Last Updated

January 12, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03620162

Brief Title

A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

Official Title

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 18, 2018 (Actual)

Primary Completion Date

December 14, 2020 (Actual)

Study Completion Date

December 14, 2020 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

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

900 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114

Arm Type

Experimental

Arm Description

Arm Title

Group 3: Prevnar 13™-Prevnar 13™-V114-V114

Arm Type

Experimental

Arm Description

Arm Title

Group 4: Prevnar 13™-V114-V114-V114

Arm Type

Experimental

Arm Description

Arm Title

Group 5: V114-V114-V114-V114

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Prevnar 13™

Intervention Description

Prevnar 13™ contains the 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 given via IM injection.

Intervention Type

Biological

Intervention Name(s)

V114

Other Intervention Name(s)

VAXNEUVANCE™

Intervention Description

V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.

Intervention Type

Biological

Intervention Name(s)

RotaTeq™

Other Intervention Name(s)

V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Intervention Description

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Intervention Type

Biological

Intervention Name(s)

Pentacel™

Other Intervention Name(s)

Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Intervention Description

Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

Intervention Type

Biological

Intervention Name(s)

RECOMBIVAX HB™

Other Intervention Name(s)

V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Intervention Description

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

Intervention Type

Biological

Intervention Name(s)

HIBERIX™

Other Intervention Name(s)

Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Intervention Description

HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

Intervention Type

Biological

Intervention Name(s)

M-M-R™ II

Other Intervention Name(s)

V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Intervention Description

M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.

Intervention Type

Biological

Intervention Name(s)

VARIVAX™

Other Intervention Name(s)

V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Intervention Description

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to ~14 days after each vaccination

Title

Percentage of Participants With a Solicited Systemic AE

Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to ~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.

Time Frame

Up to ~14 days after each vaccination

Title

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

Description

Time Frame

Up to ~6 months after Vaccination 4 (up to ~19 months)

Title

Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4

Description

Time Frame

30 Days after Vaccination 4 (Months 11-14)

Secondary Outcome Measure Information:

Title

Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3

Description

Time Frame

30 Days after Vaccination 3 (Month 5)

Title

Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3

Description

Time Frame

30 Days after Vaccination 3 (Month 5)

Title

GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3

Description

Time Frame

30 Days after Vaccination 3 (Month 5)

Title

Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3

Description

The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3.

Time Frame

30 Days after Vaccination 3 (Month 5)

Title

Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4

Description

Time Frame

30 Days after Vaccination 4 (Months 11-14)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

42 Days

Maximum Age & Unit of Time

90 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is Healthy, based on clinical judgment of the investigator 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. Exclusion Criteria: 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 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 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 judgment of the investigator Has a known coagulation 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 rotavirus vaccine 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 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 (e.g., parent/legal guardian or sibling) 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

Alabama Clinical Therapeutics ( Site 0015)

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Southeastern Pediatric Associates, P.A. ( Site 0002)

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Children's Clinic of Jonesboro, PA ( Site 0022)

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Davita Medical Group ( Site 0012)

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80922

Country

United States

Facility Name

Suncoast Research Associates, LLC ( Site 0035)

City

Miami

State/Province

Florida

ZIP/Postal Code

33184

Country

United States

Facility Name

Kentucky Pediatric/Adult Research Inc ( Site 0011)

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

Pediatric Associates of Fall River ( Site 0021)

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02721

Country

United States

Facility Name

Midwest Children's Health Research Institute, LLC ( Site 0024)

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68504

Country

United States

Facility Name

Midwest Children's Health Research Institute, LLC ( Site 0003)

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68505

Country

United States

Facility Name

Midwest Children's Health Research Institute, LLC ( Site 0004)

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Midwest Children's Health Research Institute, LLC ( Site 0001)

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68522

Country

United States

Facility Name

Summerwood Pediatrics ( Site 0009)

City

Liverpool

State/Province

New York

ZIP/Postal Code

13088

Country

United States

Facility Name

University of Rochester Medical Center ( Site 0029)

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

SUNY Upstate Medical University ( Site 0008)

City

Syracuse

State/Province

New York

ZIP/Postal Code

13202

Country

United States

Facility Name

Piedmont Healthcare, PA ( Site 0025)

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Coastal Pediatric Research ( Site 0006)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Parkside Pediatric ( Site 0007)

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Holston Medical Group ( Site 0018)

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Ventavia Research Group LLC ( Site 0017)

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

University of Texas Medical Branch ( Site 0023)

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

Facility Name

Wasatch Pediatrics-Cottonwood Office ( Site 0014)

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Multicare ( Site 0019)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Cooperativa de Facultad Medica Sanacoop ( Site 0057)

City

Bayamon

ZIP/Postal Code

00961

Country

Puerto Rico

Facility Name

Clinical Research of Puerto Rico ( Site 0050)

City

Guayama

ZIP/Postal Code

00784

Country

Puerto Rico

Facility Name

CAIMED Center - Ponce School of Medicine ( Site 0053)

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

San Juan Hospital ( Site 0056)

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

University of Puerto Rico ( Site 0051)

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

Srinagarind Hospital. Khon Kaen University ( Site 0093)

City

Muang

State/Province

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Chulalongkorn University ( Site 0092)

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Siriaj Hospital ( Site 0091)

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Maharaj Nakorn Chiang Mai Hospital ( Site 0090)

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Hacettepe University Faculty of Medicine ( Site 0070)

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Eskisehir Osmangazi University Faculty of Medicine ( Site 0071)

City

Eskisehir

ZIP/Postal Code

26480

Country

Turkey

Facility Name

Ege University Medical Faculty Hospital ( Site 0072)

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

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

36522265

Citation

Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13.

Results Reference

result

Learn more about this trial

A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

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