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

Novartis

Status and phase: Completed; Phase 3

Conditions: Serogroup B Meningococcal Meningitis

Treatments: Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2); Biological: Infanrix Hexa; Biological: Prevenar; Biological: Menjugate; Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1); Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00657709

EUDRACT 2007-007781-38

V72P13

Details and patient eligibility

About

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.

Enrollment: 3,630 patients

Sex: All

Ages: 55 to 89 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,630 participants in 5 patient groups

rMenB Lot1

Experimental group

Description:

Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.

Treatment:

Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)

rMenB Lot2

Experimental group

Description:

Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.

Treatment:

Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)

rMenB Lot3

Experimental group

Description:

Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.

Treatment:

Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)

Routine

Active Comparator group

Description:

Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.

Treatment:

Biological: Infanrix Hexa

Biological: Prevenar

MenC + Routine

Active Comparator group

Description:

Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.

Treatment:

Biological: Menjugate

Biological: Infanrix Hexa

Biological: Prevenar