Serogroup B Meningococcal Meningitis Clinical Trial
Official title:
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
| Verified date | September 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 3630 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 55 Days to 89 Days |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Grässl | Hall in Tirol | |
| Austria | Häckel | Kirchdorf | |
| Austria | Prieler | Neufeld a.d. Leitha | |
| Austria | Maurer | Salzburg | |
| Austria | Angermayr | Wels | |
| Austria | Sommer | Wien | |
| Czechia | Site 27 | Boskovice | |
| Czechia | Site 19 | Brno | |
| Czechia | Site11 | Cervený Kostelec | |
| Czechia | Site 22 | Chomutov | |
| Czechia | Site 14 | Decín | |
| Czechia | Site 12 | Havlíckuv Brod | |
| Czechia | Site 8 | Hradec Králové | |
| Czechia | Site 9 | Hradec Králové | |
| Czechia | Site 28 | Hranice I-mesto | |
| Czechia | Site 13 | Humpolec | |
| Czechia | Site 15 | Jindrichuv Hradec | |
| Czechia | Site 25 | Kladno 2 | |
| Czechia | Site 21 | Kolín | |
| Czechia | Site 10 | Liberec | |
| Czechia | Site 24 | Litomerice | |
| Czechia | Site 17 | Ostrava | |
| Czechia | Site 18 | Ostrava-Poruba | |
| Czechia | Site 7 | Pardubice | |
| Czechia | Site 16 | Plzen | |
| Czechia | Site 2 | Prague | |
| Czechia | Site 3 | Prague | |
| Czechia | Site 5 | Prague | |
| Czechia | Site 6 | Prague | |
| Czechia | Site 26 | Rumburk | |
| Czechia | Site 23 | Usti nad Labem | |
| Czechia | Site 20 | Znojmo | |
| Finland | Site 30 | Espoo | |
| Finland | Site 31 | Helsinki | |
| Finland | Site 32 | Helsinki | |
| Finland | Site 34 | Järvenpää | |
| Finland | Site 35 | Kokkola | |
| Finland | Site 45 | Kotka | |
| Finland | Site 46 | Kuopio | |
| Finland | Site 47 | Lahti | |
| Finland | Site 49 | Oulu | |
| Finland | Site 50 | Pori | |
| Finland | Site 51 | Seinäjoki | |
| Finland | Site 52 | Tampere | |
| Finland | Site 53 | Turku | |
| Finland | Site 33 | Vantaa | |
| Finland | Site 48 | Vantaa | |
| Germany | Site 99 | Detmold | |
| Germany | Site 92 | Espelkamp | |
| Germany | Site 95 | Freising | |
| Germany | Site 64 | Fulda | |
| Germany | Site 58 | Lauffen | |
| Germany | Site 57 | Marbach a. N. | |
| Germany | Site 91 | Munchen | |
| Germany | Site 96 | München | |
| Germany | Site 97 | München | |
| Germany | Site 81 | Porta Westfalica | |
| Germany | Site 65 | Schwieberdingen | |
| Germany | Site 94 | Weilheim | |
| Italy | Dipartimento di Scienze della Salute | Genova | |
| Italy | Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino | Messina | |
| Italy | Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia | Milano | |
| Italy | Pediatria dell' Ospedale Sacco | Milano | |
| Italy | Ospedale Maggiore della Carita'-Clinica Pediatrica | Novara | |
| Italy | Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari | Sassari | |
| Italy | ASL/TA | Taranto |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines | GlaxoSmithKline |
Austria, Czechia, Finland, Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |