Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Meningococcal Disease
About this trial
This is an interventional prevention trial for Meningococcal Disease focused on measuring toddler, Meningococcal disease, prevention, vaccination
Eligibility Criteria
Inclusion Criteria:
- Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Exclusion Criteria:
- 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/ alteration of the immune system,
- Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
Sites / Locations
- Altenburger
- Grässl
- Häckel
- Prieler
- Maurer
- Angermayr
- Sommer
- Site 27
- Site 19
- Site 22
- Site 12
- Fakulta vojenskeho zdravotnictví
- Site 28
- Site 13
- Site 25
- Site 21
- Site 10
- Site 24
- Site 18
- Site 17
- Site 16
- Site 26
- Site 23
- Site 30
- Site 31
- Site 32
- Site 34
- Site 35
- Site 45
- Site 46
- Site 47
- Site 49
- Site 50
- Site 51
- Site 52
- Site 53
- Site 33
- Site 48
- Site 99
- Site 92
- Site 95
- Site 64
- Site 58
- Site 57
- Site 80
- Site 83
- Site 97
- Site 96
- Site 91
- Site 81
- Site 65
- Site 94
- Dipartimento di Scienze della Salute
- Universita degli Studi di Messina, Policlinico G. Martino
- Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
- Pediatria dell' Ospedale Sacco
- Ospedale Maggiore di Novara
- Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
- ASL/TA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
12B12M (1a)
12B13M (1b)
12M13B15B (2a)
12M12B14B (2b)
12B12M (3a)
12B13M (3b)
12B12M_C (4a)
12B13M_C (4b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.