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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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Completed NCT03615482 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) Phase 3
Completed NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) Phase 3
Completed NCT04989465 - A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4
Completed NCT02547649 - Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) Phase 2
Completed NCT02573181 - Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) Phase 2