The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
Age range
12 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3
Timeframe: 1 month after Vaccination 3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1
Timeframe: within 7 Days after Vaccination 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2
Timeframe: within 7 Days after Vaccination 2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3
Timeframe: within 7 Days after Vaccination 3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1
Timeframe: within 7 Days after Vaccination 1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2
Timeframe: within 7 Days after Vaccination 2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3
Timeframe: within 7 Days after Vaccination 3
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1
Timeframe: within 30 Days after Vaccination 1
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2
Timeframe: within 30 Days after Vaccination 2
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3
Timeframe: within 30 Days after Vaccination 3
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination
Timeframe: within 30 Days after any Vaccination
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
Timeframe: From the Vaccination 1 up to 1 month after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase
Timeframe: From 1 month after Vaccination 3 up to 6 months after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3
Timeframe: From Vaccination 1 up to 6 months after Vaccination 3