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A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

NCT02531373•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Eligibility

Age

0 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Adult Cohort: 18 to 49 years and in good health
•Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
•Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Exclusion Criteria

•Adult cohort: Prior administration of any pneumococcal vaccine
•History of invasive pneumococcal disease
•Known hypersensitivity to any vaccine component
•Known or suspected impairment of immune function
•Coagulation disorder contraindicating intramuscular vaccination
•Received a blood transfusion or blood products within 6 months
•Participated in another clinical study of an investigational product within 2 months
•Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
•Known hypersensitivity to any vaccine component
•Known or suspected impairment of immune function
+14 more criteria

Key Dates

Start Date

September 15, 2015

Primary Completion Date

April 14, 2017

Completion Date

April 14, 2017

Last Updated

April 2, 2019

Enrollment

338

ACTUAL participants

Conditions

Pneumococcal Infections

Interventions

V114 Medium Dose

BIOLOGICAL

V114 High Dose

BIOLOGICAL

V114 Medium Dose with Alternative Carrier Protein

BIOLOGICAL

V114 High Dose with Alternative Carrier Protein

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

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NOT_YET_RECRUITINGPHASE4

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

NCT06822907

Acute Febrile IllnessPneumococcal Infections

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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: April 2, 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.

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A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

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)