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Study on the Safety and Immune Response of PF-07831695 and a Drug Combination for Pneumococcal Infections in Healthy Toddlers Aged 12-15 Months

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and immune response of a new vaccine candidate in healthy toddlers. The vaccine is designed to protect against Pneumococcal Infections, which are caused by bacteria that can lead to illnesses such as pneumonia, ear infections, and meningitis. The study involves a vaccine known as a Monovalent Pneumococcal Conjugate Candidate, which will be given in two doses to children aged 12 to 15 months who have already received a primary series of another vaccine called PCV10.

The purpose of the study is to observe how the children's bodies react to the new vaccine. This includes monitoring for any local reactions like redness, swelling, or pain at the injection site, as well as systemic events such as fever, decreased appetite, increased sleepiness, or irritability. The study will also track any adverse events, which are unexpected medical problems that occur during the study, and serious adverse events, which are more severe health issues.

Additionally, the study will measure the levels of Immunoglobulin G (IgG), a type of antibody, and the opsonophagocytic activity (OPA), which is a measure of the vaccine's ability to help the immune system fight off the bacteria. The trial is expected to provide valuable information on the vaccine's safety and effectiveness in boosting the immune response in young children.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the toddler must be between the ages of 11 and 15 months. The toddler should have previously received exactly two doses of the PCV10 vaccine as part of the local immunization schedule. A clinical assessment will be conducted to ensure the toddler is healthy and eligible to participate.

  2. Step 2

    First dose administration

    The toddler will receive the first dose of the monovalent pneumococcal conjugate candidate vaccine. This vaccine is administered as a suspension for injection using an intramuscular route. The injection is given in the muscle, typically in the upper arm or thigh.

  3. Step 3

    Monitoring after first dose

    After the first dose, the toddler will be monitored for any local reactions such as redness, swelling, or pain at the injection site. Monitoring will also include checking for systemic events like fever, decreased appetite, increased sleep, or irritability. Any adverse events or serious adverse events will be recorded.

  4. Step 4

    Second dose administration

    The toddler will receive the second dose of the vaccine. This dose is also administered as a suspension for injection using an intramuscular route. The timing of the second dose will be determined by the study schedule.

  5. Step 5

    Monitoring after second dose

    Following the second dose, the toddler will again be monitored for any local reactions and systemic events. Any adverse events or serious adverse events will be documented. The study will also measure immunoglobulin G (IgG) concentrations and opsonophagocytic activity (OPA) titers to assess the immune response to the vaccine.

  6. Step 6

    Completion of study

    The study is expected to conclude by May 21, 2024. At the end of the study, all collected data will be analyzed to evaluate the safety and immune response to the vaccine in toddlers.

Who can join the trial?

3 criteria

  • Children who are 11 to 15 months old at the time of joining the study.
  • Have received exactly 2 doses of a vaccine called PCV10 as part of their local vaccination schedule.
  • Must be healthy according to a doctor's assessment, which includes looking at their medical history and overall health.

Who cannot join the trial?

9 criteria

  • Children who are not between the ages of 11 months and 15 months cannot participate.
  • Children who have any serious health conditions that might affect their safety during the study cannot participate.
  • Children who have had a severe allergic reaction to any vaccine in the past cannot participate.
  • Children who are currently participating in another clinical trial cannot participate.
  • Children who have received any other vaccines within 30 days before the start of the study cannot participate.
  • Children who have a weakened immune system, which means their body has a harder time fighting infections, cannot participate.
  • Children who have a history of seizures or other neurological disorders, which are problems related to the brain and nerves, cannot participate.
  • Children who have any bleeding disorders, which means their blood does not clot properly, cannot participate.
  • Children who have any chronic illnesses that require regular medication cannot participate.
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Investigated drugs

mPnC is a new vaccine being tested in this clinical trial. It is designed to protect against infections caused by a specific type of bacteria known as pneumococcus. This vaccine is given in two doses to young children who have already received a different pneumococcal vaccine called PCV10. The goal of this trial is to see how safe the mPnC vaccine is and how well it helps the body build protection against the bacteria.

What is already known about the treatment

Monovalent Pneumococcal Conjugate Candidate – This medication is administered as an injection, specifically designed for young children aged 12 to 15 months who have previously received a primary series of PCV10. It is currently being studied in clinical trials to assess its safety and ability to trigger an immune response against pneumococcal infections. The main therapeutic use of this vaccine is to protect against infections caused by the pneumococcus bacteria, which can lead to serious illnesses like pneumonia. At the molecular level, the vaccine works by introducing a small, harmless piece of the bacteria to the body, which helps the immune system recognize and fight the real bacteria if encountered in the future. This medication falls under the pharmacological classification of vaccines, which are substances used to stimulate the production of antibodies and provide immunity against diseases.

Investigated diseases

Pneumococcal Infections – Pneumococcal infections are caused by the bacterium Streptococcus pneumoniae. These infections can affect various parts of the body, including the lungs, ears, sinuses, and bloodstream. In the lungs, it can lead to pneumonia, characterized by symptoms such as cough, fever, and difficulty breathing. When it affects the ears, it can cause otitis media, leading to ear pain and possible hearing issues. In the bloodstream, it can result in bacteremia, which may cause fever and chills. The progression of the disease depends on the site of infection and the individual's immune response.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-505154-18-00Protocol codeC4801002Estimated enrolment100 patientsSponsorPfizer Inc.

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