The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
956
0.5 mL dose, subcutaneous administration in right anterolateral thigh
0.5 mL dose, subcutaneous administration in right anterolateral thigh
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) 1 month after completion of the primary vaccination in single-dose groups compared to the two-dose group
Time frame: 1 month
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
Time frame: 6 to 9 months (from 4-6 months of age until 12-13 months of age)
Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose
Time frame: 1 month after booster dose (administered between 12-13 months of age)
Antibody titers (rSBA) titers one month after completion of the primary vaccination
Time frame: 1 month after primary vaccination
Antibody titers (rSBA titers) prior to the administration of the booster dose
Time frame: Prior to booster dose
Antibody titers (rSBA titers)one month after the administration of the booster dose
Time frame: 1 month after administration of booster dose
Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination
Time frame: Within 3 days after vaccination
Frequency and severity of adverse events observed during the entire follow up period
Time frame: Entire follow up period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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...and 14 more locations