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Completed

NCT Number: NCT04633226

Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

42 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jeonbuk National University Hospital ( Site 0008), Jeonju, Jeonrabugdo, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent
  • has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent

Exclusion criteria

  • has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease
  • has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
  • has had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) within 72 hours prior to receipt of study vaccine
  • has known or suspected impairment of immunological function
  • has or his/her mother has human immunodeficiency virus (HIV) infection
  • has or his/her mother has hepatitis B surface antigen-positive test
  • has known or history of functional or anatomic asplenia
  • has a history of autoimmune disease
  • has a history or suspected history of neurological disorder
  • has received a pneumococcal vaccine prior to study entry
  • has received, or is anticipated to need, corticosteroid therapy
  • has received a blood transfusion of immunoglobulin products
  • has participated in another clinical study of an investigational product

Treatment and study plan

V114

Biological

15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.

Other names: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

Primary outcomes

  1. Percentage of Participants With ≥1 Solicited Injection-site Adverse Events

    Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of erythema, induration, pain, and swelling.

  2. Percentage of Participants With ≥1 Solicited Systemic Adverse Events

    Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs consist of decreased appetite, irritability, somnolence, and urticaria.

  3. Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events

    Time frame: Up to approximately 14.5 months

    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following any dose of V114 was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.

  4. Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event

    Time frame: Up to approximately 13 months

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued study treatment due to an AE is reported.

  5. Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL

    Time frame: 30 days after vaccination 3 (Up to a total of ~5 months)

    The percentage of participants with immunoglobulin G (IgG) threshold values of ≥0.35 µg/mL for the 15 serotypes contained in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 30 days postdose 3 is reported. The multiplex, pneumococcal electrochemiluminescence (PnECL) v2.0 assay was used to quantify IgG serotype-specific antibodies.

  6. Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3

    Time frame: 30 days after vaccination 3 (Up to a total of ~5 months)

    The anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG geometric mean concentrations (GMCs) at 30 days postdose 3 for each serotype-specific were reported. The multiplex, electrochemiluminescence (ECL)-based PnECL v2.0 assay was used to quantify IgG serotype-specific antibodies.

Secondary outcomes

  1. Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4

    Time frame: 30 days after vaccination 4 (Up to a total of ~14 months)

    The anti-PnPs serotype-specific IgG GMCs at 30 days postdose 4 for each serotype-specific were reported. The multiplex, ECL-based PnECL v2.0 assay was used.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.

Acronym: PNEU-PED-KOR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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