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

COMPLETEDPHASE2

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

A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

NCT02987972•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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™.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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
+5 more criteria

Locations (49)

Birmingham Pediatric Research ( Site 0043)

Birmingham, Alabama, United States

Southeastern Pediatric Associates, P.A. ( Site 0079)

Dothan, Alabama, United States

Children's Clinic of Jonesboro, PA ( Site 0054)

Jonesboro, Arkansas, United States

Premier Health Research Center, LLC ( Site 0035)

Downey, California, United States

Sherif Khamis MD, Inc. ( Site 0044)

Palmdale, California, United States

Kaiser Permanente - Roseville ( Site 0045)

Roseville, California, United States

Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)

Sacramento, California, United States

Kentucky Pediatric/Adult Research Inc ( Site 0037)

Bardstown, Kentucky, United States

University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)

Louisville, Kentucky, United States

ACC Pediatric Research ( Site 0039)

Haughton, Louisiana, United States

Key Dates

Start Date

March 21, 2017

Primary Completion Date

October 4, 2018

Completion Date

October 4, 2018

Last Updated

October 23, 2019

Enrollment

1,051

ACTUAL participants

Conditions

Pneumococcal Infections

Interventions

V114 Lot 1

BIOLOGICAL

V114 Lot 2

BIOLOGICAL

Prevnar 13™

BIOLOGICAL

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

NCT06998251

Pneumococcal InfectionsRespiratory Syncytial Virus (RSV) Infection+1 more

View study

NOT_YET_RECRUITINGPHASE4

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

NCT06822907

Acute Febrile IllnessPneumococcal Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage

Immunization To Prevent Acute COPD Exacerbations

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)