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.
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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