A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Pneumococcal Infection

Treatments: Biological: V118C (Stage 1); Biological: PCV20 (Stage 2); Biological: PCV20 (Stage 1); Biological: V118C (Stage 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07300267

V118C-002

Details and patient eligibility

About

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.

This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.

Full description

Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).

Enrollment: 210 estimated patients

Sex: All

Ages: 2 to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

Stage 1:

• Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
• Is 12 through 15 months of age

Stage 2:

- Is approximately 2 months of age

Both Stages:

• Was born at full term (gestational age greater than or equal to 37 weeks)

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

Stage 1:

- Has received a PCV dose at 10 months of age and older

Stage 2:

• Has received prior administration of any pneumococcal vaccine

Both stages:

• Has a history of invasive pneumococcal disease (IPD)
• Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 4 patient groups

V118C (Stage 1)

Experimental group

Description:

Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.

Treatment:

Biological: V118C (Stage 1)

V118C (Stage 2)

Experimental group

Description:

Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.

Treatment:

Biological: V118C (Stage 2)

PCV20 (Stage 1)

Active Comparator group

Description:

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.

Treatment:

Biological: PCV20 (Stage 1)

PCV20 (Stage 2)

Active Comparator group

Description:

Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.

Treatment:

Biological: PCV20 (Stage 2)