Neisseria Meningitidis
Conditions
Brief summary
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.
Interventions
BIOLOGICALMeningococcal group C polysaccharide conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
BIOLOGICALPneumococcal 13-valent conjugate vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
BIOLOGICALCombined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
0.5 mL dose, subcutaneous administration in right anterolateral thigh
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 11 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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 (\>= 37 weeks) with a birth weight \>= 2 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
Exclusion criteria
* 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 * 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 |
|---|---|
| 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 | 1 month |
| Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose | 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 | 1 month after booster dose (administered between 12-13 months of age) |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination | Within 3 days after vaccination |
| Antibody titers (rSBA) titers one month after completion of the primary vaccination | 1 month after primary vaccination |
| Frequency and severity of adverse events observed during the entire follow up period | Entire follow up period |
| Antibody titers (rSBA titers) prior to the administration of the booster dose | Prior to booster dose |
| Antibody titers (rSBA titers)one month after the administration of the booster dose | 1 month after administration of booster dose |
Countries
Poland, Spain
Outcome results
None listed