Completed

Study Description:

The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals’ Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa. The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

GSK Study ID:

106388


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT00327184


EudraCT Number:

2005-005421-59


Study Overview

Medical Conditions

Immune, Inflammatory & Infections - Other

Product

SB811936

Collaborators

N/A


Date

April 2006 to November 2006

Type

Interventional

Phase

3


Gender

Both

Age

6 weeks - 12 weeks

Accepts Healthy Volunteers

Yes


This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

Finland, Espoo 02100Completed
Finland, Helsinki 00100Completed
Finland, Helsinki 00930Completed
Finland, Jarvenpaa 04400Completed
Finland, Kotka 48100Completed
Finland, Lahti 15140Completed
Finland, Oulu 90100Completed
Finland, Pori 28120Completed
Finland, Tampere 33200Completed
Finland, Turku 20520Completed
Finland, Vantaa 01600Completed
Finland, Vantaa 01300Completed
Italy, Lombardia, Lodi 26900Completed
Italy, Puglia, Bari 70124Completed
Italy, Sardegna, Sassari 07100Completed
Italy, Sicilia, Ragusa 97100Completed

Study Design

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • SBA-MenC titre
    Timeframe: One month after the second dose of the Primary Vaccination Phase.

  • Anti-PRP concentration
    Timeframe: One month after the second dose of the Primary Vaccination Phase

Secondary Outcomes:

  • SBA-MenC titres
    Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination

  • Anti-PRP concentrations
    Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination

  • Anti-PSC concentrations
    Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.

  • Anti-HBs concentrations
    Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination

  • Occurrence of local solicited adverse events.
    Timeframe: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.

  • Occurrence of solicited general adverse events
    Timeframe: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.

  • Occurrence of unsolicited non-serious adverse events
    Timeframe: Within 30 days after each vaccination

  • Occurrence of any serious adverse events
    Timeframe: Throughout the study.

Arms:
  • 2

Interventions:

  • Biological/Vaccine: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
  • Biological/Vaccine: Infanrix Penta
  • Biological/Vaccine: Infanrix hexa
  • Biological/Vaccine: Neis-Vac-C
Enrollment: 709

Clinical Publications:

  • Vesikari T et al. (2013) A combined Haemophilus influenza type b-Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus at 3, 5 and 11 months of age: results of an open, randomized, controlled study. Pediatr Infect Dis J. 32(5):521-529.