Study on the Safety and Immune Response of mRNA-1345 and mRNA-1365 for Infants with Acute Lower Respiratory Infection Aged 5 to 24 Months

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of two investigational vaccines, mRNA-1345 and mRNA-1365, in young children aged 5 months to less than 24 months. These vaccines are being tested to see how well they work in preventing infections caused by respiratory viruses, specifically those that can lead to acute lower respiratory infection, which is a condition affecting the lungs and airways.

The study involves giving participants injections of the vaccines and monitoring them for any reactions or side effects. Some participants will receive the actual vaccines, while others will receive a placebo, which is a substance with no active ingredients. The purpose of the study is to evaluate the safety and how the body responds to these vaccines, which are designed to help the immune system fight off infections.

Throughout the study, participants will be closely observed for any signs of illness or adverse reactions. The study aims to gather information on how the vaccines affect the immune system and whether they can help prevent serious respiratory infections in young children. This research is important for developing new ways to protect children from these infections and improve their overall health.

1 initial visit

Upon joining the study, the participant will attend an initial visit. During this visit, the participant’s health will be assessed to ensure they meet the study requirements. This includes a review of medical history and a physical examination.

The participant’s parent or legal representative will be required to provide written informed consent, confirming their understanding and agreement to follow the study procedures.

2 first injection

The participant will receive the first injection. This injection may contain either the study vaccine mRNA-1345, mRNA-1365, or a placebo, which is a harmless solution used for comparison.

The injection is administered as an intramuscular injection, meaning it is given directly into a muscle.

3 monitoring period

After the injection, the participant will be monitored for any immediate reactions. This monitoring period helps ensure the participant’s safety and allows for the observation of any side effects.

The participant’s parent or legal representative will be asked to report any changes in the participant’s health or any side effects they notice.

4 follow-up visits

The participant will attend several follow-up visits over the course of the study. These visits are scheduled to monitor the participant’s health and to collect information on how the participant’s body is responding to the injection.

During these visits, additional health assessments may be conducted, and the participant’s parent or legal representative will be asked to provide updates on the participant’s health.

5 second injection

The participant will receive a second injection, similar to the first one. This injection is also administered as an intramuscular injection.

The second injection may occur at a specified time after the first injection, as determined by the study protocol.

6 final assessment

At the end of the study, a final assessment will be conducted. This assessment will evaluate the participant’s overall health and any effects of the injections received during the study.

The participant’s parent or legal representative will be asked to provide any final observations or concerns regarding the participant’s health.

Who Can Join the Study?

The participant must be a male or female child.
The participant’s age must be:
- 8 months to less than 24 months for Part A
- 5 months to less than 8 months for Part B
- 8 months to less than 12 months for Part C
- 5 months to less than 24 months for Part D
The participant must be in good general health as determined by the study doctor, based on medical history and a physical exam. Common mild conditions like mild to moderate GERD (a condition where stomach acid flows back into the tube connecting your mouth and stomach) or atopic dermatitis (a skin condition causing itchy, inflamed skin) are allowed if they do not interfere with the study.
The participant’s parent(s) or legally authorized representative(s) must understand and be willing and able to follow the study requirements, including all procedures, and must provide written consent.
The participant must be growing normally for their age, according to the study doctor, in the months before joining the study.
The participant must have been born at full-term (37 weeks or more of pregnancy) with a minimum birth weight of 2.5 kg (about 5.5 pounds).
The participant’s parent(s) or legally authorized representative(s) must have a consistent way to be contacted, either by phone or email/computer.
For Part C Cohort 7 and Part D Cohorts 11 and 12: The participant must have received nirsevimab (a medication) at least 6 months before the first study visit.
For Part C Cohort 8: The participant was eligible to receive nirsevimab at any time since birth, according to national guidelines, but did not receive it before the first study visit.

Who Cannot Join the Study?

Patients with an acute lower respiratory infection cannot participate. This means if you have a sudden infection in your lungs or airways, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Instituto Hispalense De Pediatria S.L.	Sevilla	Spain
Vidzemes bernu veselibas centrs Apelsins SIA	Valmiera	Latvia

Other Sites

Site Name	City	Country
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Hm Puerta Del Sur	Mostoles	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Fyborhilb Pjdj Lk Inhmcbrmdjelh Bvgubtdgj Dtb Hriduzmu Ugmzfkyvsyxwi Lh Pma	Madrid	Spain
Syprnqv Iih Szs Jwlyxdh Svfsxqsm W Tzgludyby Szolswzlpik Phjincodk Zigbvq Ozllfr Zcnamlljaw	Trzebnica	Poland
Vcofgykt &cgof Varndii Szp z ogyv	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Latvia	Not recruiting	02.06.2023
Poland	Not recruiting	02.06.2023
Spain	Not recruiting	02.06.2023

Trial locations

Investigated drugs:

mRNA-1345 is a new type of vaccine that uses a small piece of genetic material called messenger RNA (mRNA) to help the body recognize and fight off certain viruses. This vaccine is designed to teach the immune system to identify and respond to specific virus proteins, which can help protect against infections. In this trial, researchers are studying how safe and well-tolerated this vaccine is in young children, as well as how well it helps their immune systems respond to the virus.

mRNA-1365 is another vaccine that also uses messenger RNA technology. Like mRNA-1345, it aims to train the immune system to recognize and combat specific virus proteins. The goal of this vaccine is to provide protection against infections by helping the body prepare a defense before encountering the actual virus. The trial is focused on understanding the safety and immune response of this vaccine in young children.

Acute lower respiratory infection – This disease affects the lower part of the respiratory system, including the airways and lungs. It is characterized by symptoms such as coughing, difficulty breathing, and chest discomfort. The infection can be caused by various pathogens, including viruses and bacteria. As the disease progresses, inflammation in the airways and lungs can lead to increased mucus production and impaired oxygen exchange. In severe cases, it may result in significant breathing difficulties and require medical intervention. The condition can vary in severity and duration, depending on the underlying cause and the individual’s health status.

Trial ID:

2022-502022-41-00

Protocol code:

mRNA-1365-P101

NCT ID:

NCT05743881

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Immune Response of mRNA-1345 and mRNA-1365 for Infants with Acute Lower Respiratory Infection Aged 5 to 24 Months

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?