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Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00327184
First received: May 16, 2006
Last updated: June 7, 2012
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Meningococcal Serogroup Diseases
 Biological: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
Biological: Infanrix Penta
Biological: Infanrix hexa
Biological: Neis-Vac-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: Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3,5m of Age & Persistence Prior to a Hib-MenC Booster at 11m & Immunogenicity of the Booster

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • SBA-MenC titre [ Time Frame: One month after the second dose of the Primary Vaccination Phase. ] [ Designated as safety issue: No ]
  • Anti-PRP concentration [ Time Frame: One month after the second dose of the Primary Vaccination Phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SBA-MenC titres [ Time Frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination ] [ Designated as safety issue: No ]
  • Anti-PRP concentrations [ Time Frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination ] [ Designated as safety issue: No ]
  • Anti-PSC concentrations [ Time Frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination. ] [ Designated as safety issue: No ]
  • Anti-HBs concentrations [ Time Frame: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination ] [ Designated as safety issue: No ]
  • Occurrence of local solicited adverse events. [ Time Frame: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of solicited general adverse events [ Time Frame: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited non-serious adverse events [ Time Frame: Within 30 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any serious adverse events [ Time Frame: Throughout the study. ] [ Designated as safety issue: No ]

Enrollment: 709
Study Start Date: April 2006
Study Completion Date: June 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Hib-MenC
Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines.
 Biological: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
Biological: Infanrix Penta
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
Active Comparator: Group NeisVac-C
Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.
 Biological: Infanrix hexa
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
Biological: Neis-Vac-C
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Detailed Description:

This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Primary Phase:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • healthy male or female subject between, and including, 6 and 12 weeks of age at the time of the first vaccination, born after a gestation period between and including 36 and 42 weeks.
  • Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Booster Phase:

• Participation in primary phase of study.

Exclusion Criteria

Primary Phase:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG.
  • Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease
  • History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Additional Exclusion criteria for the Booster Phase:

• Previous booster vaccination with Hib and/or MenC and/or DTP containing and/or IPV containing and/or HepB containing vaccine(s).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327184

Locations
Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90100
Italy
GSK Investigational Site
Lodi, Lombardia, Italy, 26900
GSK Investigational Site
Bari, Puglia, Italy, 70124
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
GSK Investigational Site
Ragusa, Sicilia, Italy, 97100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00327184     History of Changes
Other Study ID Numbers: 106388, 106390
Study First Received: May 16, 2006
Last Updated: June 7, 2012
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
PENTA
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 13, 2013