Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Pneumococcal Infection Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425732
• Other study ID #: V116-003
• Secondary ID: V116-0032022-000
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2022
• Est. completion date: May 18, 2023

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2663
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.

Exclusion Criteria:

• Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)

• Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria toxoid

• Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease

• Has a coagulation disorder contraindicating IM vaccination

• Had a recent febrile illness (defined as oral or tympanic temperature =100.4°F [=38.0°C] or axillary or temporal temperature =99.4°F [=37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine

• Has a known malignancy that is progressing or has required active treatment <3 years before enrollment

• Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol

• Received systemic corticosteroids (prednisone equivalent of =20 mg/day) for =14 consecutive days and has not completed intervention =14 days before receipt of study vaccine

• Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease

• Received any nonlive vaccine =14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine =30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)

• Received any live virus vaccine =30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine =30 days after receipt of study vaccine

• Received a blood transfusion or blood products, including immunoglobulin =6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• V116
0.5 mL injection solution in prefilled syringe containing 4 µg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
• PCV20
0.5 mL injection suspension in prefilled syringe containing 2.2 µg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 µg of PnPs antigen 6B.

Locations

Country	Name	City	State
Australia	Emeritus Research ( Site 3004)	Botany	New South Wales
Australia	Paratus Clinical Research Canberra ( Site 3000)	Bruce	Australian Capital Territory
Australia	Emeritus Research ( Site 3003)	Camberwell	Victoria
Australia	Paratus Clinical Research Central Coast ( Site 3001)	Kanwal	New South Wales
Australia	Westmead Hospital ( Site 3005)	Westmead	New South Wales
Belgium	Anima Diepenbeek ( Site 1003)	Diepenbeek	Limburg
Belgium	Private Practice - Dr. Martinot Jean-Benoit ( Site 1001)	Erpent	Namur
Chile	Universidad San Sebastian - Providencia ( Site 0514)	Providencia	Region M. De Santiago
Chile	Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)	Santiago	Region M. De Santiago
Chile	Espacio Eme ( Site 0509)	Santiago	Region M. De Santiago
Chile	Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504)	Temuco	Araucania
Germany	Novopraxis Berlin GbR ( Site 1201)	Berlin
Germany	Medizentrum Essen Borbeck ( Site 1200)	Essen	Nordrhein-Westfalen
Germany	InfektioResearch ( Site 1203)	Frankfurt	Hessen
Germany	Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)	Hamburg
Germany	Universitaetsklinikum Koeln ( Site 1206)	Köln	Nordrhein-Westfalen
Korea, Republic of	Korea University Ansan Hospital ( Site 3201)	Ansan-si	Kyonggi-do
Korea, Republic of	Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207)	Deagu	Taegu-Kwangyokshi
Korea, Republic of	Gachon University Gil Medical Center ( Site 3205)	Namdong-gu	Incheon
Korea, Republic of	Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208)	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204)	Seoul
Korea, Republic of	Korea University Guro Hospital ( Site 3200)	Seoul
Korea, Republic of	Samsung Medical Center ( Site 3211)	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210)	Seoul
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203)	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202)	Seoul
Korea, Republic of	Ajou University Hospital-Department of Infectious Diseases ( Site 3209)	Suwon-si	Kyonggi-do
Korea, Republic of	The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206)	Suwon-si	Kyonggi-do
New Zealand	Southern Clinical Trials Waitemata Ltd ( Site 3105)	Auckland
New Zealand	Southern Clinical Trials Ltd ( Site 3104)	Christchurch	Canterbury
New Zealand	Lakeland Clinical Trials ( Site 3102)	Rotorua	Bay Of Plenty
New Zealand	P3 Research - Tauranga ( Site 3100)	Tauranga	Bay Of Plenty
New Zealand	P3 Research - Wellington ( Site 3101)	Wellington
Puerto Rico	Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601)	Bayamon
Puerto Rico	San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606)	Caguas
Puerto Rico	Clinical Research Investigator Group ( Site 0611)	Canovanas
Puerto Rico	Ponce School Of Medicine Caimed Center ( Site 0602)	Ponce
Puerto Rico	Clinical Research Puerto Rico ( Site 0600)	San Juan
Sweden	ProbarE ( Site 1400)	Lund	Skane Lan
Sweden	CTC Karolinska ( Site 1405)	Solna	Stockholms Lan
Sweden	ProbarE i Stockholm AB ( Site 1401)	Stockholm	Stockholms Lan
Sweden	Studieenheten Akademiskt Specialistcentrum ( Site 1403)	Stockholm	Stockholms Lan
Sweden	CTC MTC ( Site 1404)	Uppsala	Uppsala Lan
Taiwan	National Cheng Kung University Hospital ( Site 3301)	Tainan
Taiwan	National Taiwan University Hospital ( Site 3300)	Taipei
Taiwan	Taipei Medical University Hospital ( Site 3302)	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch ( Site 3303)	Taoyuan
Turkey	Sakarya Training and Research Hospital ( Site 2205)	Adapazari	Sakarya
Turkey	Ankara City Hospital ( Site 2200)	Ankara
Turkey	Hacettepe Universite Hastaneleri ( Site 2204)	Ankara
Turkey	Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)	Istanbul
United States	JEM Research Institute ( Site 0072)	Atlantis	Florida
United States	Lynn Institute of Denver ( Site 0012)	Aurora	Colorado
United States	Tekton Research, Inc. ( Site 0053)	Austin	Texas
United States	Central Research Associates ( Site 0067)	Birmingham	Alabama
United States	Charlottesville Medical Research ( Site 0034)	Charlottesville	Virginia
United States	Aventiv Research Inc ( Site 0044)	Columbus	Ohio
United States	Alliance for Multispecialty Research, LLC ( Site 0015)	Coral Gables	Florida
United States	WR-Global Medical Research, LLC ( Site 0065)	Dallas	Texas
United States	Hillcrest Medical Research ( Site 0049)	DeLand	Florida
United States	Skyline Medical Center/CCT Research ( Site 0028)	Elkhorn	Nebraska
United States	Southland Clinical Research Center-Research ( Site 0054)	Fountain Valley	California
United States	Methodist Physicians Clinic/CCT Research ( Site 0058)	Fremont	Nebraska
United States	Lenzmeier Family Medicine/CCT Research ( Site 0006)	Glendale	Arizona
United States	Velocity Clinical Research, Greenville ( Site 0043)	Greenville	South Carolina
United States	Olympus Family Medicine/CCT Research ( Site 0074)	Holladay	Utah
United States	Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032)	Horseheads	New York
United States	Elixir Research Group - W Houston ( Site 0068)	Houston	Texas
United States	Clinical Research Prime ( Site 0010)	Idaho Falls	Idaho
United States	East Coast Institute for Research, LLC ( Site 0070)	Jacksonville	Florida
United States	Alliance for Multispecialty Research, LLC ( Site 0026)	Kansas City	Missouri
United States	Sunwise Clinical Research ( Site 0024)	Lafayette	California
United States	East Coast Institute for Research ( Site 0071)	Lake City	Florida
United States	Chemidox Clinical Trials ( Site 0048)	Lancaster	California
United States	Excel Clinical Research, LLC ( Site 0077)	Las Vegas	Nevada
United States	Healor Primary Care / CCT Research ( Site 0056)	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029)	Las Vegas	Nevada
United States	Epic Clinical Research ( Site 0082)	Lewisville	Texas
United States	Baptist Health Center For Clinical Research ( Site 0019)	Little Rock	Arkansas
United States	DCOL Center for Clinical Research ( Site 0051)	Longview	Texas
United States	Advanced Medical Research ( Site 0002)	Maumee	Ohio
United States	Solaris Clinical Research ( Site 0008)	Meridian	Idaho
United States	Desert Clinical Research/ CCT Research ( Site 0040)	Mesa	Arizona
United States	Advanced Medical Research Institute ( Site 0014)	Miami	Florida
United States	L&C Professional Medical Research Institute ( Site 0025)	Miami	Florida
United States	Trial Management Associates ( Site 0089)	Myrtle Beach	South Carolina
United States	Health Research of Hampton Roads, Inc. ( Site 0004)	Newport News	Virginia
United States	Meridian Clinical Research, LLC ( Site 0045)	Norfolk	Nebraska
United States	Lynn Institute of Norman ( Site 0001)	Norman	Oklahoma
United States	South Ogden Family Medicine/ CCT Research ( Site 0022)	Ogden	Utah
United States	Lynn Health Science Institute ( Site 0005)	Oklahoma City	Oklahoma
United States	Headlands Research Orlando ( Site 0031)	Orlando	Florida
United States	Foothills Research Center/ CCT Research ( Site 0021)	Phoenix	Arizona
United States	Research Your Health ( Site 0042)	Plano	Texas
United States	Summit Headlands ( Site 0047)	Portland	Oregon
United States	Paradigm Clinical Research Centers, Inc ( Site 0018)	Redding	California
United States	Peninsula Research Associates ( Site 0079)	Rolling Hills Estates	California
United States	IMA Clinical Research San Antonio ( Site 0009)	San Antonio	Texas
United States	VIP Trials ( Site 0086)	San Antonio	Texas
United States	Acclaim Clinical Research ( Site 0083)	San Diego	California
United States	Millennium Clinical Trials ( Site 0013)	Simi Valley	California
United States	MultiCare Rockwood Cheney Clinic ( Site 0037)	Spokane	Washington
United States	Clinical Research Trials of Florida ( Site 0007)	Tampa	Florida
United States	Genesis Clinical Research, LLC ( Site 0016)	Tampa	Florida
United States	Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003)	Tempe	Arizona
United States	Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036)	Tomball	Texas
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038)	Troy	Michigan
United States	Lynn Institute of Tulsa ( Site 0084)	Tulsa	Oklahoma
United States	Versailles Family Medicine / CCT Research ( Site 0063)	Versailles	Kentucky
United States	Palm Beach Research Center ( Site 0060)	West Palm Beach	Florida
United States	Paradigm Clinical Research Centers, Inc ( Site 0027)	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Chile,  Germany,  Korea, Republic of,  New Zealand,  Puerto Rico,  Sweden,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Solicited Injection-site Adverse Events (AEs)	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. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.	Up to 5 days post-vaccination
Primary	Percentage of Participants With Solicited Systemic AEs	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. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature = 100.4 °F/38.0 °C)	Up to 5 days post-vaccination
Primary	Percentage of Participants With Vaccine-related Serious AE (SAE)	A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event, which is determined by the investigator to be related to the vaccine.	Up to 194 days post-vaccination
Primary	Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20	The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Day 30 post-vaccination
Primary	Percentage of Participants With =4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116	The percentage of participants with =4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Baseline and Day 30 post-vaccination
Primary	Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116	The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.	Day 30 post-vaccination
Secondary	Percentage of Participants From Cohort 1 V116 With =4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes	The percentage of participants with =4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a =4-fold rise from baseline being > 50 percentage points (one-sided p-value < 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.	Baseline and Day 30 post-vaccination
Secondary	Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2	The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.	Day 30 post-vaccination
Secondary	Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20	The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Day 30 post-vaccination
Secondary	Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20	The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Baseline and Day 30 post-vaccination
Secondary	Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20	The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Baseline and Day 30 post-vaccination
Secondary	Percentage of Participants With =4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20	Percentage of participants with =4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Baseline and Day 30 post-vaccination
Secondary	Percentage of Participants With =4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20	Percentage of participants with =4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.	Baseline and Day 30 post-vaccination

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary