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

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987972
• Other study ID #: V114-008
• Secondary ID: 2016-001117-25
• Status: Completed
• Phase: Phase 2
• Start date: March 21, 2017
• Est. completion date: October 4, 2018

Study information

• Verified date: September 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1051
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• V114 Lot 1
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
• V114 Lot 2
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
• Prevnar 13™
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

Locations

Country	Name	City	State
Canada	CHU Ste-Justine ( Site 0084)	Montreal	Quebec
Canada	McGill University Health Centre - Vaccine Study Centre ( Site 0030)	Pierrefonds	Quebec
Canada	CHU de Quebec Universite de Laval ( Site 0031)	Quebec
Denmark	Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)	Aarhus N
Denmark	OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)	Odense
Finland	Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)	Espoo
Finland	Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)	Helsinki
Finland	Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)	Helsinki
Finland	Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)	Järvenpää
Finland	Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)	Oulu
Finland	Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)	Pori
Finland	Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)	Tampere
Finland	Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)	Turku
Israel	Soroka University Medical Center ( Site 0019)	Beer-Sheva
Israel	Soroka University Medical Center - Rahat Family health center ( Site 0020)	Beer-Sheva
Israel	Soroka University Medical Center - Ramot Family health center ( Site 0021)	Beer-Sheva
Israel	Soroka University Medical Center - Vav Family health center ( Site 0022)	Beer-Sheva
Spain	Hospital Clinico Universitario de Santiago ( Site 0016)	Santiago de Compostela
Spain	Unidad de Estudios e Investigacion IHP ( Site 0017)	Sevilla
United States	Kentucky Pediatric/Adult Research Inc ( Site 0037)	Bardstown	Kentucky
United States	Birmingham Pediatric Research ( Site 0043)	Birmingham	Alabama
United States	Coastal Pediatric Research ( Site 0070)	Charleston	South Carolina
United States	Pediatric Research of Charlottesville, LLC ( Site 0066)	Charlottesville	Virginia
United States	Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)	Cincinnati	Ohio
United States	Senders Pediatrics ( Site 0058)	Cleveland	Ohio
United States	Ohio Pediatric Research Association ( Site 0060)	Dayton	Ohio
United States	Southeastern Pediatric Associates, P.A. ( Site 0079)	Dothan	Alabama
United States	Premier Health Research Center, LLC ( Site 0035)	Downey	California
United States	Pediatric Medical Associates ( Site 0059)	East Norriton	Pennsylvania
United States	Child Health Care Associates ( Site 0064)	East Syracuse	New York
United States	Family Health Care of Ellensburg ( Site 0077)	Ellensburg	Washington
United States	University of Texas Medical Branch at Galveston ( Site 0056)	Galveston	Texas
United States	ACC Pediatric Research ( Site 0039)	Haughton	Louisiana
United States	Kid's Way Pediatrics ( Site 0036)	Hermitage	Pennsylvania
United States	Children's Clinic of Jonesboro, PA ( Site 0054)	Jonesboro	Arkansas
United States	Holston Medical Group [Kingsport, TN] ( Site 0048)	Kingsport	Tennessee
United States	Wee Care Pediatrics ( Site 0042)	Layton	Utah
United States	University of Texas Medical Branch at Galveston ( Site 0068)	League City	Texas
United States	University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)	Louisville	Kentucky
United States	Huguenot Pediatrics ( Site 0057)	Midlothian	Virginia
United States	Cottonwood Pediatrics ( Site 0041)	Murray	Utah
United States	Dundee Clinic ( Site 0063)	Omaha	Nebraska
United States	Sherif Khamis MD, Inc. ( Site 0044)	Palmdale	California
United States	Thomas Jefferson University ( Site 0067)	Philadelphia	Pennsylvania
United States	Kaiser Permanente - Roseville ( Site 0045)	Roseville	California
United States	Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)	Sacramento	California
United States	Copperview Medical Center ( Site 0062)	South Jordan	Utah
United States	State University of New York Upstate Medical University ( Site 0065)	Syracuse	New York
United States	Woburn Pediatric Associates ( Site 0046)	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post vaccination 3 (Month 5)
Primary	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.	1 month post Vaccination 3 (Month 5)
Primary	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.	Up to 1 month post Vaccination 4 (up to 14 months)
Primary	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.	Up to 1 month post Vaccination 4 (up to 14 months)
Primary	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.	Up to 14 days post any vaccination
Primary	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.	Up to 14 days post any vaccination
Secondary	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.	Before Vaccination 4 (Month 10 to 13)
Secondary	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.	1 month post vaccination 4 (Month 11-14)