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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
V114 Lot 1
V114 Lot 2
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

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infant approximately 2 months of age (42 days to 90 days), inclusive
  • In good health

Exclusion Criteria:

  • Prior administration of any pneumococcal vaccine
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency (eg, splenomegaly)
  • Mother has documented human immunodeficiency virus (HIV) infection
  • Mother has documented hepatitis B surface antigen-positive test result
  • Known or history of functional or anatomic asplenia
  • History of failure to thrive
  • History of a coagulation disorder
  • History of autoimmune disease
  • Known neurologic or cognitive behavioral disorder
  • Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
  • Prior administration of a blood transfusion or blood products, including immunoglobulin
  • Participated in another clinical trial of an investigational product
  • History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease

Sites / Locations

  • Birmingham Pediatric Research ( Site 0043)
  • Southeastern Pediatric Associates, P.A. ( Site 0079)
  • Children's Clinic of Jonesboro, PA ( Site 0054)
  • Premier Health Research Center, LLC ( Site 0035)
  • Sherif Khamis MD, Inc. ( Site 0044)
  • Kaiser Permanente - Roseville ( Site 0045)
  • Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
  • Kentucky Pediatric/Adult Research Inc ( Site 0037)
  • University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
  • ACC Pediatric Research ( Site 0039)
  • Woburn Pediatric Associates ( Site 0046)
  • Dundee Clinic ( Site 0063)
  • Child Health Care Associates ( Site 0064)
  • State University of New York Upstate Medical University ( Site 0065)
  • Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)
  • Senders Pediatrics ( Site 0058)
  • Ohio Pediatric Research Association ( Site 0060)
  • Pediatric Medical Associates ( Site 0059)
  • Kid's Way Pediatrics ( Site 0036)
  • Thomas Jefferson University ( Site 0067)
  • Coastal Pediatric Research ( Site 0070)
  • Holston Medical Group [Kingsport, TN] ( Site 0048)
  • University of Texas Medical Branch at Galveston ( Site 0056)
  • University of Texas Medical Branch at Galveston ( Site 0068)
  • Wee Care Pediatrics ( Site 0042)
  • Cottonwood Pediatrics ( Site 0041)
  • Copperview Medical Center ( Site 0062)
  • Pediatric Research of Charlottesville, LLC ( Site 0066)
  • Huguenot Pediatrics ( Site 0057)
  • Family Health Care of Ellensburg ( Site 0077)
  • CHU Ste-Justine ( Site 0084)
  • McGill University Health Centre - Vaccine Study Centre ( Site 0030)
  • CHU de Quebec Universite de Laval ( Site 0031)
  • Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)
  • OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)
  • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
  • Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)
  • Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
  • Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
  • Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
  • Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
  • Soroka University Medical Center ( Site 0019)
  • Soroka University Medical Center - Rahat Family health center ( Site 0020)
  • Soroka University Medical Center - Ramot Family health center ( Site 0021)
  • Soroka University Medical Center - Vav Family health center ( Site 0022)
  • Hospital Clinico Universitario de Santiago ( Site 0016)
  • Unidad de Estudios e Investigacion IHP ( Site 0017)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

V114 Lot 1

V114 Lot 2

Prevnar 13™

Arm Description

Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.
Percentage of Participants Who Experience at Least 1 Adverse Event
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.
Percentage of Participants With a Solicited Systemic Adverse Event
Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.

Secondary Outcome Measures

Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.

Full Information

First Posted
December 6, 2016
Last Updated
October 2, 2019
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02987972
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Official Title
A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (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, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1051 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V114 Lot 1
Arm Type
Experimental
Arm Description
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Arm Title
V114 Lot 2
Arm Type
Experimental
Arm Description
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Arm Title
Prevnar 13™
Arm Type
Active Comparator
Arm Description
Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Intervention Type
Biological
Intervention Name(s)
V114 Lot 1
Other Intervention Name(s)
V114-1
Intervention Description
Lot 1: 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
Intervention Type
Biological
Intervention Name(s)
V114 Lot 2
Other Intervention Name(s)
V114-2
Intervention Description
Lot 2: 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
Intervention Type
Biological
Intervention Name(s)
Prevnar 13™
Intervention Description
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
Description
Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Time Frame
1 month post vaccination 3 (Month 5)
Title
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
Description
Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.
Time Frame
1 month post Vaccination 3 (Month 5)
Title
Percentage of Participants Who Experience at Least 1 Adverse Event
Description
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.
Time Frame
Up to 1 month post Vaccination 4 (up to 14 months)
Title
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
Description
The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
Time Frame
Up to 1 month post Vaccination 4 (up to 14 months)
Title
Percentage of Participants With a Solicited Injection-site Adverse Event
Description
Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.
Time Frame
Up to 14 days post any vaccination
Title
Percentage of Participants With a Solicited Systemic Adverse Event
Description
Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.
Time Frame
Up to 14 days post any vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4
Description
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Time Frame
Before Vaccination 4 (Month 10 to 13)
Title
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4
Description
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Time Frame
1 month post vaccination 4 (Month 11-14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infant approximately 2 months of age (42 days to 90 days), inclusive In good health Exclusion Criteria: Prior administration of any pneumococcal vaccine Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine Known or suspected impairment of immunological function History of congenital or acquired immunodeficiency (eg, splenomegaly) Mother has documented human immunodeficiency virus (HIV) infection Mother has documented hepatitis B surface antigen-positive test result Known or history of functional or anatomic asplenia History of failure to thrive History of a coagulation disorder History of autoimmune disease Known neurologic or cognitive behavioral disorder Expects to require systemic corticosteroids within 30 days after each vaccination during the trial Prior administration of a blood transfusion or blood products, including immunoglobulin Participated in another clinical trial of an investigational product History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
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
Birmingham Pediatric Research ( Site 0043)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Southeastern Pediatric Associates, P.A. ( Site 0079)
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Children's Clinic of Jonesboro, PA ( Site 0054)
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Premier Health Research Center, LLC ( Site 0035)
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Sherif Khamis MD, Inc. ( Site 0044)
City
Palmdale
State/Province
California
ZIP/Postal Code
93550
Country
United States
Facility Name
Kaiser Permanente - Roseville ( Site 0045)
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Kentucky Pediatric/Adult Research Inc ( Site 0037)
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
ACC Pediatric Research ( Site 0039)
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
Woburn Pediatric Associates ( Site 0046)
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
Facility Name
Dundee Clinic ( Site 0063)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
Facility Name
Child Health Care Associates ( Site 0064)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
State University of New York Upstate Medical University ( Site 0065)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Senders Pediatrics ( Site 0058)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Ohio Pediatric Research Association ( Site 0060)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Pediatric Medical Associates ( Site 0059)
City
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Kid's Way Pediatrics ( Site 0036)
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
Thomas Jefferson University ( Site 0067)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Coastal Pediatric Research ( Site 0070)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Holston Medical Group [Kingsport, TN] ( Site 0048)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
University of Texas Medical Branch at Galveston ( Site 0056)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas Medical Branch at Galveston ( Site 0068)
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Wee Care Pediatrics ( Site 0042)
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Cottonwood Pediatrics ( Site 0041)
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Copperview Medical Center ( Site 0062)
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC ( Site 0066)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Huguenot Pediatrics ( Site 0057)
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23113
Country
United States
Facility Name
Family Health Care of Ellensburg ( Site 0077)
City
Ellensburg
State/Province
Washington
ZIP/Postal Code
98926
Country
United States
Facility Name
CHU Ste-Justine ( Site 0084)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H9H 4M7
Country
Canada
Facility Name
McGill University Health Centre - Vaccine Study Centre ( Site 0030)
City
Pierrefonds
State/Province
Quebec
ZIP/Postal Code
H9H 4M7
Country
Canada
Facility Name
CHU de Quebec Universite de Laval ( Site 0031)
City
Quebec
ZIP/Postal Code
H9H 4M7
Country
Canada
Facility Name
Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)
City
Aarhus N
Country
Denmark
Facility Name
OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)
City
Odense
Country
Denmark
Facility Name
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
City
Espoo
Country
Finland
Facility Name
Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)
City
Helsinki
Country
Finland
Facility Name
Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
City
Helsinki
Country
Finland
Facility Name
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
City
Järvenpää
Country
Finland
Facility Name
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
City
Oulu
Country
Finland
Facility Name
Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
City
Pori
Country
Finland
Facility Name
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
City
Tampere
Country
Finland
Facility Name
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
City
Turku
Country
Finland
Facility Name
Soroka University Medical Center ( Site 0019)
City
Beer-Sheva
Country
Israel
Facility Name
Soroka University Medical Center - Rahat Family health center ( Site 0020)
City
Beer-Sheva
Country
Israel
Facility Name
Soroka University Medical Center - Ramot Family health center ( Site 0021)
City
Beer-Sheva
Country
Israel
Facility Name
Soroka University Medical Center - Vav Family health center ( Site 0022)
City
Beer-Sheva
Country
Israel
Facility Name
Hospital Clinico Universitario de Santiago ( Site 0016)
City
Santiago de Compostela
Country
Spain
Facility Name
Unidad de Estudios e Investigacion IHP ( Site 0017)
City
Sevilla
Country
Spain

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
32639460
Citation
Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC, Shekar T, Li J, Hurtado K, Su SC, Nolan KM, Acosta CJ, McFetridge RD, Bickham K, Musey LK; V114-008 Study Group. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020 Aug;39(8):763-770. doi: 10.1097/INF.0000000000002765.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

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