NeisVac-C Single Prime Study in Infants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants

Conditions
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Neisseria Meningitidis

Intervention / Treatment
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* Biological: Meningococcal group C polysaccharide conjugate vaccine
* Biological: Pneumococcal 13-valent conjugate vaccine
* Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 11 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age | Biological: Meningococcal group C polysaccharide conjugate vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: NeisVac-C;Biological: Pneumococcal 13-valent conjugate vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: Prevenar 13;Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: Infanrix hexa;|
| Experimental: Group 2<br>Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age | Biological: Meningococcal group C polysaccharide conjugate vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: NeisVac-C;Biological: Pneumococcal 13-valent conjugate vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: Prevenar 13;Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: Infanrix hexa;|
| Active Comparator: Group 3<br>Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age | Biological: Meningococcal group C polysaccharide conjugate vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: NeisVac-C;Biological: Pneumococcal 13-valent conjugate vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: Prevenar 13;Biological: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine<br>* 0.5 mL dose, subcutaneous administration in right anterolateral thigh<br>* Other names: Infanrix hexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titers (rSBA) titers one month after completion of the primary vaccination |  | 1 month after primary vaccination | 
| 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 | 
| Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination |  | Within 3 days after vaccination | 
| Frequency and severity of adverse events observed during the entire follow up period |  | Entire follow up period |