Phase 2
N=1,507
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Meningococcal Meningitis · Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00937521 ↗Enrolled (actual)
1,507
Serious AEs
7.4%
Results posted
Mar 2015
Primary outcome: Primary: Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination — 5; 2; 4; 4 Percentages of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Meningococcal B vaccine (Biological); Control (Biological); Meningococcal B vaccine with antipyretic (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination |
5; 2; 4; 4; 4; 4 | — |
| PRIMARY Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination |
94; 91; 74; 24; 60; 76 | — |
| SECONDARY Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age) |
1.25; 1.12; 1.2; 1.19; 1.31; 1.2 | — |
| SECONDARY Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) |
1.25; 1.18; 101; 102; 4.94; 4.51 | — |
| SECONDARY Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age) |
80; 84; 24; 28; 345; 417 | — |
| SECONDARY Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose) |
55; 58; 66; 63; 45; 44 | — |
| SECONDARY Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose) |
100; 100; 100; 97; 100; 99 | — |
| SECONDARY Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age) |
120; 12; 1950; 41; 20; 2.2 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster) |
84; 93; 24 | — |
| SECONDARY Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination |
90; 82; 76; 35; 74; 89 | — |
| SECONDARY Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination |
163; 155; 153; 123; 141; 157 | — |
| SECONDARY Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination |
167; 173; 175; 152; 162; 171 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination |
55; 52; 51; 33; 35; 39 | — |
| SECONDARY Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period. |
0; 2; 2; 0; 0; 1 | — |
| SECONDARY Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group |
92; 84; 59; 35; 43; 57 | — |
Summary
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Eligibility Criteria
Inclusion Criteria
- Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
- Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements
Exclusion Criteria
- Any meningococcal B or C vaccine administration
- Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
- Any ascertained or suspected disease caused by N. meningitidis
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
- History of severe allergic reaction after previous vaccinations
- Recent significant acute or chronic infection
- Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
- Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
- Any impairment/alteration of the immune system resulting from (for example):
- Receipt of any immunosuppressive therapy at any time since birth
- Receipt of immunostimulants at any time since birth
- Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
- Participation in another clinical trial
- Family members and household members of research staff
- History of seizure
- Any contraindication to paracetamol
Data sourced from ClinicalTrials.gov (NCT00937521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.