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Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Streptococcus Pneumoniae Infection
Pneumococcal Infections

Treatments

Biological: Prevnar 13®
Biological: V114 2x:1x:2x
Biological: V114 1x:1x:1x
Biological: V114 2x:2x:2x
Biological: V114 1x:1x:2x
Biological: V114 0.5x:0.5x:2x

Study type

Interventional

Funder types

Industry

Identifiers

NCT02037984
V114-004

Details and patient eligibility

About

This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.

Enrollment

341 patients

Sex

All

Ages

6 weeks to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Infants:

  • Healthy and able to attend all scheduled visits.

Adults:

  • Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.

Exclusion Criteria

Infants and Adults:

  • Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
  • History of invasive pneumococcal disease.
  • Known hypersensitivity to any vaccine component.
  • Received systemic corticosteroids within 14 days of first vaccination.
  • Known or suspected impairment of immune function.
  • Febrile illness within 72 hours before vaccination.
  • Received blood transfusion or blood products within 30 days. Infants
  • Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
  • Has asplenia or failure to thrive.

Adults:

  • Is breastfeeding.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

341 participants in 8 patient groups

Adult V114: 1x:1x:1x
Experimental group
Description:
Adults receive a single vaccination on Day 1.
Treatment:
Biological: V114 1x:1x:1x
Adult V114: 2x:2x:2x
Experimental group
Description:
Adults receive a single vaccination on Day 1.
Treatment:
Biological: V114 2x:2x:2x
Infant V114: 1x:1x:1x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 1x:1x:1x
Infant V114: 2x:1x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 2x:1x:2x
Infant V114: 2x:2x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 2x:2x:2x
Infant V114: 0.5x:0.5x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 0.5x:0.5x:2x
Infant V114: 1x:1x:2x
Experimental group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: V114 1x:1x:2x
Infant Prevnar 13®
Active Comparator group
Description:
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
Treatment:
Biological: Prevnar 13®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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