A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine when Administered to Healthy Infants

Conditions

Infections, Meningococcal

Brief summary

Number and percentage of participants with: -solicited administration site and systemic events during the 7 days (including the day of vaccination) after each vaccination. -any unsolicited adverse events (AEs), including medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal and adverse events of special interest (AESIs), during the 30 days after each vaccination. -MAEs, SAEs, AEs leading to withdrawal and AESIs throughout the study., Percentages of participants with human serum bactericidal assay (hSBA) titres ≥lower limit of quantitation (LLOQ) and the hSBA geometric mean titres (GMTs) for each A, C, W and Y serogroup and each serogroup B indicator strain at: -1 month after the second vaccination (Day 91) -pre-third vaccination (Day 301) -1 month after the third vaccination (Day 331) hSBA geometric mean ratios (GMRs) for each A, C, W and Y serogroup and B indicator strains at Day 331 compared to pre third vaccination

Related papers

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Interventions

DRUGNimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A

DRUGC

DRUGW-135 and Y conjugate vaccine

DRUGPrevenar 13 suspension for injection pneumococcal polysaccharide conjugate vaccine (13-valent

DRUGadsorbed)

DRUGRotarix oral suspension in pre-filled oral applicator Rotavirus vaccine

DRUGlive

DRUGInfanrix hexa

DRUGPowder and suspension for suspension for injection. Diphtheria (D)

DRUGtetanus (T)

DRUGpertussis (acellular

DRUGcomponent) (Pa)

DRUGhepatitis B (rDNA) (HBV)

DRUGpoliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).

DRUGBexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA

DRUGcomponent

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Number and percentage of participants with: -solicited administration site and systemic events during the 7 days (including the day of vaccination) after each vaccination. -any unsolicited adverse events (AEs), including medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal and adverse events of special interest (AESIs), during the 30 days after each vaccination. -MAEs, SAEs, AEs leading to withdrawal and AESIs throughout the study., Percentages of participants with human serum bactericidal assay (hSBA) titres ≥lower limit of quantitation (LLOQ) and the hSBA geometric mean titres (GMTs) for each A, C, W and Y serogroup and each serogroup B indicator strain at: -1 month after the second vaccination (Day 91) -pre-third vaccination (Day 301) -1 month after the third vaccination (Day 331) hSBA geometric mean ratios (GMRs) for each A, C, W and Y serogroup and B indicator strains at Day 331 compared to pre third vaccination	—

Measure

Time frame

Number and percentage of participants with: -solicited administration site and systemic events during the 7 days (including the day of vaccination) after each vaccination. -any unsolicited adverse events (AEs), including medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal and adverse events of special interest (AESIs), during the 30 days after each vaccination. -MAEs, SAEs, AEs leading to withdrawal and AESIs throughout the study., Percentages of participants with human serum bactericidal assay (hSBA) titres ≥lower limit of quantitation (LLOQ) and the hSBA geometric mean titres (GMTs) for each A, C, W and Y serogroup and each serogroup B indicator strain at: -1 month after the second vaccination (Day 91) -pre-third vaccination (Day 301) -1 month after the third vaccination (Day 331) hSBA geometric mean ratios (GMRs) for each A, C, W and Y serogroup and B indicator strains at Day 331 compared to pre third vaccination

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Countries

Germany, Poland, Spain

Outcome results

None listed