Active immunization for the prevention of invasive disease caused by Neisseria meningitidis serogroup C. MedDRA version: 13.1 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: NeisVac-C Baxter
Product Name: Meningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed
Product Code: n.a.
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descript
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Approximately 948 infants (aged 2 months) who meet ALL of the following criteria are eligible for this study: • Subject is an infant aged 8 to 11 weeks at the time of first vaccination; • Subject is clinically healthy as determined by the investigator’s clinical judgment through collection of medical history and physical examination; • Subject was born at full term of pregnancy (equal to or above 37 weeks) with a birth weight equal to or above 2.0 kg; • The parent(s) or legally authorized representative of the subject provides written consent for participation; • The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol; • The parent(s) or legally authorized representative and the subject will be available for the duration of the study; • The parent(s) or legally authorized representative of the subject agrees to keep a subject diary Are the trial subjects under 18? yes Number of subjects for this age range: 948 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet ANY of the following criteria are not eligible for this study: • Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines; • Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study; • Subject has a rash or dermatologic condition which may interfere with injection site reaction rating; • Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder; • Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response (such treatment includes, but is not limited to: systemic or high dose inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs); • Subject has received any blood products or immunoglobulins within 60 days of study entry; • Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination; • Subject has previously been vaccinated against meningococcal C disease; • Subject has a known or suspected immune dysfunction; • Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.); • Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product; • Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study Investigator or with a study team member. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings) as well as employees of the Investigator or site conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To evaluate vaccine safety in infants as determined by local and systemic reactions;Primary end point(s): There are three co-primary end points related to immunogenicity: • Number of subjects with seroprotective antibody titers (rSBA titers = 8) one month after completion of the primary vaccination in single dose groups compared to the two dose group and; • Number of subjects with seroprotective antibody titers (rSBA titers = 8) prior to the administration of the booster dose and; • Number of subjects with seroprotective antibody titers (rSBA titers = 128) one month after the administration of the booster dose. ;Timepoint(s) of evaluation of this end point: One month after completion of the primary vaccination, prior to the administration of the booster dose, and one month after the administration of the booster dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity rSBA titers one month after completion of the primary vaccination; rSBA titers prior to the administration of the booster dose; rSBA titers one month after the administration of the booster dose. Safety Frequency and severity of local and systemic reactions with onset within 3 days after each vaccination Frequency and severity of adverse events (AEs) observed during the entire follow-up period;Timepoint(s) of evaluation of this end point: Immunogenicity One month after completion of the primary vaccination, prior to the administration of the booster dose, and one month after the administration of the booster dose. Safety Evaluation of local and systemic reactions within 3 days after each vaccination and of adverse events (AEs) during the entire follow-up period. | — |
Countries
Poland, Spain
Contacts
Public ContactGuido Wuerth, MD
Baxter Innovations GmbH
Outcome results
None listed