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

Conditions

• Pneumococcal Infection

Eligibility Criteria

Sex

ALL

Age

2 Months - 15 Months

Healthy Volunteers

Accepted

Interventions

• V118C (Stage 1) — BIOLOGICAL
  IM administration of V118C
• V118C (Stage 2) — BIOLOGICAL
  IM administration of V118C
• PCV20 (Stage 1) — BIOLOGICAL
  IM administration of PCV20
• PCV20 (Stage 2) — BIOLOGICAL
  IM administration of PCV20

Study Details

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.

Key Dates

Start date

Jan 13, 2026

Status verified

Apr 2026

Primary completion

Oct 24, 2028

Completion

May 25, 2029

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: V118C (Stage 1)
  Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
• Experimental: V118C (Stage 2)
  Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.
• Active Comparator: PCV20 (Stage 1)
  Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
• Active Comparator: PCV20 (Stage 2)
  Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.

Primary Outcome Measure

Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination [ Time Frame: Up to approximately 30 minutes postvaccination ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (14)

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