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

NCT00657709 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3630

Last updated 2017-10-10

Study results available
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Summary

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.

Conditions

  • Serogroup B Meningococcal Meningitis

Interventions

BIOLOGICAL

Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)

One dose of rMenB Lot concomitantly with the routinely administered infant vaccines

BIOLOGICAL

Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)

One dose of rMenB concomitantly with the routinely administered infant vaccines

BIOLOGICAL

Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)

One dose of rMenB concomitantly with the routinely administered infant vaccines

BIOLOGICAL

Infanrix Hexa

Routine vaccination

BIOLOGICAL

Menjugate

One dose of the routinely administered infant vaccines + MenC vaccine

BIOLOGICAL

Prevenar

Routine vaccination

Sponsors & Collaborators

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Austria
  • Czechia
  • Finland
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657709 on ClinicalTrials.gov