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OpenTrials
Completed

NCT Number: NCT05412030

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants

This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV).

Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13.

In Part 2, infants will be randomized to receive either one of two dose levels of AFX3772 or PCV20.

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Key information

Conditions

Pneumonia, Bacterial Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Pneumonia Pneumonia, Pneumococcal Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

42 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Bayamón, Puerto Rico

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 full-term infant approximately 2 months of age at time of obtaining the informed consent.

Exclusion criteria

  • Had prior administration of any pneumococcal vaccine.
  • Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
  • Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
  • Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series.
  • Has a history of microbiologically proven invasive disease caused by S. pneumoniae.
  • Has received immunoglobulins.
  • Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
  • Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.

Treatment and study plan

AFX3772

Biological

AFX3772 administered intramuscularly.

Prevnar 13

Biological

PCV13 administered intramuscularly.

Other names: PCV13

Prevnar 20

Biological

PCV 20 administered intramuscularly.

Other names: PCV20

Primary outcomes

  1. Percentage of participants with solicited injection site events

    Time frame: Day 1 through Day 7 post-vaccination

    The assessed solicited injection site events are tenderness, redness/erythema and swelling.

  2. Percentage of participants with solicited systemic events

    Time frame: Day 1 through Day 7 post-vaccination

    The assessed solicited systemic events are irritability, fever, decrease of appetite, increased sleep, and decrease in sleep.

  3. Percentage of participants with AEs

    Time frame: Day 1 through Day 30

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.

  4. Percentage of participants with serious adverse events (SAEs)

    Time frame: Day 1 through 6 months post dose three

    An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity.

    Medical or scientific judgment will be exercised by the investigator in deciding whether SAE reporting is appropriate in other situations such as significant medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

Secondary outcomes

  1. Percentage of participants with a pneumococcal serotype-specific Immunoglobulin G (IgG) concentration of greater than or equal to (>=) 0.35 μg/mL or corresponding threshold

    Time frame: 30 days post-dose two, 30 days post-dose three

    Immunological responses were assessed in terms of percentage of participants with a pneumococcal serotype-specific IgG concentration >= 0.35 μg/mL or corresponding threshold.

  2. Geometric mean concentration for serotype-specific IgG

    Time frame: 30 days post-dose two, 30 days post-dose three

    Immunological responses were assessed in terms of IgG GMCs and expressed as titers.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCVs in Healthy Infants

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2022
Registry last updated
Oct 21, 2025

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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