Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Study Overview
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Brief Summary
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The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.

Official Title
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A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Conditions
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Serogroup B Meningococcal Meningitis

Intervention / Treatment
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* Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
* Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
* Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
* Biological: Infanrix Hexa
* Biological: Menjugate
* Biological: Prevenar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy 2-month old infants (55-89 days, inclusive) Exclusion Criteria: Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens) Previous ascertained or suspected disease caused by N. meningitidis History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; Any serious chronic or progressive disease Known or suspected impairment or alteration of the immune system

Ages Eligible for Study
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Minimum Age: 55 Days
Maximum Age: 89 Days

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: rMenB Lot1<br>Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)<br>* One dose of rMenB Lot concomitantly with the routinely administered infant vaccines<br>|
| Experimental: rMenB Lot2<br>Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)<br>* One dose of rMenB concomitantly with the routinely administered infant vaccines<br>|
| Experimental: rMenB Lot3<br>Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. | Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)<br>* One dose of rMenB concomitantly with the routinely administered infant vaccines<br>|
| Active Comparator: Routine<br>Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. | Biological: Infanrix Hexa<br>* Routine vaccination<br>Biological: Prevenar<br>* Routine vaccination<br>|
| Active Comparator: MenC + Routine<br>Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. | Biological: Infanrix Hexa<br>* Routine vaccination<br>Biological: Menjugate<br>* One dose of the routinely administered infant vaccines + MenC vaccine<br>Biological: Prevenar<br>* Routine vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination | The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs). | one month after the third vaccination | 
| The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) | The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported. | one month after the third vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) | The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination. | 1 month after the third vaccination | 
| Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ | The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ. | 1 Month after the third vaccination | 
| Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) | The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination. | 1 month after third vaccination | 
| Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations | Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination. | 1 month after third vaccination | 
| Percentages of Subjects With Antibody Response Against the Routine Antigens | The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml | 1 Month after third vaccination | 
| Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens | Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid). | 5 months | 
| Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination | Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age. | 1 Month after third vaccination | 
| Percentage of Subjects With hSBA Titers ≥1:8 | Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains. | 1 month after third vaccination | 
| Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine | The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events. | upto 7 days after any vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, Meningococcal disease, prevention, vaccination