Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00657709
First received: April 2, 2008
Last updated: October 21, 2011
Last verified: October 2011
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Purpose
The proposed study is aimed to assess the immunogenicity, safety and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease |
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: Routine vaccination Biological: Meningococcal group C |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Meningococcal Infections
Drug Information available for:
Meningococcal Vaccines
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Immunogenicity as measured by serum bactericidal activity (SBA) of 3 doses of Meningococcal B vaccine when given to infants concomitantly with routine infant vaccines [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: No ]
- Consistency of immune response from 3 lots of Meningococcal B Vaccine (SBA geometric mean titer) [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: No ]
- Safety and tolerability of 3 doses of Meningococcal B vaccine when given concomitantly with routine infant vaccines [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Consistency of immune response from 3 lots of Meningococcal B vaccine, as measured by percentage of subjects with SBA titer ≥1:4 [ Time Frame: 5 months ] [ Designated as safety issue: No ]
- Non-inferiority of immunogenicity of routine infant vaccines when given concomitantly with Meningococcal B vaccine to that of routine infant vaccines given alone. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
- Prevalence of meningococcal B antibodies in the subjects that received routine infant vaccines only. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
| Enrollment: | 3630 |
| Study Start Date: | March 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
|
| Experimental: 2 |
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
|
| Experimental: 3 |
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
|
| Active Comparator: 4 |
Biological: Routine vaccination
Routine vaccination
|
| Active Comparator: 5 |
Biological: Meningococcal group C
One dose of the routinely administered infant vaccines + MenC vaccine
|
Eligibility| Ages Eligible for Study: | 55 Days to 89 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657709
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| Austria | |
| Altenburger | |
| Eisenstadt, Austria, 7000 | |
| Grässl | |
| Hall in Tirol, Austria, 6060 | |
| Häckel | |
| Kirchdorf, Austria, 4560 | |
| Prieler | |
| Neufeld a.d. Leitha, Austria, 2491 | |
| Maurer | |
| Salzburg, Austria, 5020 | |
| Angermayr | |
| Wels, Austria, 4600 | |
| Sommer | |
| Wien, Austria, 1230 | |
| Czech Republic | |
| Site 27 | |
| Boskovice, Czech Republic, 680 01 | |
| Site 19 | |
| Brno, Czech Republic, 628 00 | |
| Site 22 | |
| Chomutov, Czech Republic, 430 03 | |
| Site 14 | |
| Děčín, Czech Republic, 405 01 | |
| Site 12 | |
| Havlíčkův Brod, Czech Republic, 580 22 | |
| Site 8 | |
| Hradec Králové, Czech Republic, 500 01 | |
| Site 9 | |
| Hradec Králové, Czech Republic, 500 05 | |
| Fakulta vojenskeho zdravotnictví | |
| Hradec Králové, Czech Republic, 500 01 | |
| Site 28 | |
| Hranice I-mesto, Czech Republic, 753 01 | |
| Site 13 | |
| Humpolec, Czech Republic, 396 01 | |
| Site 15 | |
| Jindřichův Hradec, Czech Republic, 377 01 | |
| Site 25 | |
| Kladno 2, Czech Republic, 272 00 | |
| Site 21 | |
| Kolín, Czech Republic, 280 02 | |
| Site 10 | |
| Liberec, Czech Republic, 460 15 | |
| Site 24 | |
| Litomerice, Czech Republic, 412 01 | |
| Site 17 | |
| Ostrava, Czech Republic, 702 00 | |
| Site 18 | |
| Ostrava-Poruba, Czech Republic, 708 68 | |
| Site 7 | |
| Pardubice, Czech Republic, 532 03 | |
| Site 16 | |
| Plzeň, Czech Republic, 305 99 | |
| Site 4 | |
| Prague, Czech Republic, 150 00 | |
| Site 6 | |
| Prague, Czech Republic, 19000 | |
| Site 2 | |
| Prague, Czech Republic, 130 00 | |
| Site 5 | |
| Prague, Czech Republic, 16000 | |
| Site 3 | |
| Prague, Czech Republic, 140 00 | |
| Site 26 | |
| Rumburk, Czech Republic, 408 01 | |
| Site 23 | |
| Usti nad Labem, Czech Republic, 400 01 | |
| Site 20 | |
| Znojmo, Czech Republic, 669 00 | |
| Site11 | |
| Červený Kostelec, Czech Republic, 54941 | |
| Finland | |
| Site 30 | |
| Espoo, Finland, 02100 | |
| Site 31 | |
| Helsinki, Finland, 00100 | |
| Site 32 | |
| Helsinki, Finland, 00930 | |
| Site 34 | |
| Järvenpää, Finland, 04400 | |
| Site 35 | |
| Kokkola, Finland, 67100 | |
| Site 45 | |
| Kotka, Finland, 48600 | |
| Site 46 | |
| Kuopio, Finland, 70100 | |
| Site 47 | |
| Lahti, Finland, 15140 | |
| Site 49 | |
| Oulu, Finland, 90220 | |
| Site 50 | |
| Pori, Finland, 28100 | |
| Site 51 | |
| Seinäjoki, Finland, 60100 | |
| Site 52 | |
| Tampere, Finland, 33100 | |
| Site 53 | |
| Turku, Finland, 20520 | |
| Site 33 | |
| Vantaa, Finland, 01300 | |
| Site 48 | |
| Vantaa, Finland, 01600 | |
| Germany | |
| Site 99 | |
| Detmold, Germany, 32756 | |
| Site 92 | |
| Espelkamp, Germany, 32339 | |
| Site 95 | |
| Freising, Germany, 85354 | |
| Site 64 | |
| Fulda, Germany, 36037 | |
| Site 58 | |
| Lauffen, Germany, 74348 | |
| Site 57 | |
| Marbach a. N., Germany, 71672 | |
| Site 96 | |
| München, Germany, 81475 | |
| Site 83 | |
| München, Germany, 81241 | |
| Site 80 | |
| München, Germany, 80337 | |
| Site 97 | |
| München, Germany, 81377 | |
| Site 91 | |
| Műnchen, Germany, 81737 | |
| Site 81 | |
| Porta Westfalica, Germany, 32457 | |
| Site 65 | |
| Schwieberdingen, Germany, 71701 | |
| Site 94 | |
| Weilheim, Germany, 82362 | |
| Italy | |
| Dipartimento di Scienze della Salute | |
| Genova, Italy, 16132 | |
| Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino | |
| Messina, Italy, 98122 | |
| Pediatria dell' Ospedale Sacco | |
| Milano, Italy, 20157 | |
| Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia | |
| Milano, Italy, 20122 | |
| Ospedale Maggiore della Carita'-Clinica Pediatrica | |
| Novara, Italy, 28100 | |
| Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari | |
| Sassari, Italy, 07100 | |
| ASL/TA | |
| Taranto, Italy, 74100 | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00657709 History of Changes |
| Other Study ID Numbers: | V72P13, EUDRACT 2007-007781-38 |
| Study First Received: | April 2, 2008 |
| Last Updated: | October 21, 2011 |
| Health Authority: | United States: Food and Drug Administration Finland: Finnish Medicines Agency Germany: Paul-Ehrlich-Institut Switzerland: Swissmedic Czech Republic: SUKL Austria: Federal Office for Safety in Health Care |
Keywords provided by Novartis:
|
infant Meningococcal disease prevention vaccination |
Additional relevant MeSH terms:
|
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 22, 2013