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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: October 6, 2016
Last verified: October 2016
  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
Neisseria Meningitidis
Haemophilus Influenzae Type b
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, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster

Resource links provided by NLM:


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: November 2006
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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Pori, Finland, 28120
GSK Investigational Site
Tampere, Finland, 33200
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
GSK Investigational Site
Vantaa, Finland, 01600
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

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106388
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106388
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106388
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106388
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106388
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106388
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 106388 are summarised with study 106390 on the GSK Clinical Study Register.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00327184     History of Changes
Other Study ID Numbers: 106388  106390 
Study First Received: May 16, 2006
Last Updated: October 6, 2016
Health Authority: Finland: Finnish Medicines Agency
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Vaccines
PENTA
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016