Study in Toddlers to Demonstrate Non-Inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00326118

Purpose

The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.

In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Haemophilus Infection Meningococcal Infection	Biological: Hiberix™ Biological: Meningitec™ Biological: Priorix™ Biological: Haemophilus influenzae type b and meningococcal serogroup C (vaccine)	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Measles-Mumps-Rubella Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Demonstrate Non-Inferiority of GSK Biologicals' Hib-MenC With Priorix™, Versus MenC-CRM197 Vaccine With Hiberix™ & Priorix™ in Toddlers Primed With Hib But Not MenC & to Evaluate Persistence up to 5y After Vaccination.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

SBA-MenC titre [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
Anti-PRP concentration [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SBA-MenC titre [ Time Frame: Prior to and 1 month after vaccination and 1, 2, 3, 4, and 5 years after vaccination. ] [ Designated as safety issue: No ]
Anti-PRP concentration [ Time Frame: Prior to and 1 month after vaccination and 1, 2, 3, 4, and 5 years after vaccination ] [ Designated as safety issue: No ]
Anti-PSC concentration [ Time Frame: Prior to and 1 month after vaccination and 1, 2, 3, 4, and 5 years after vaccination ] [ Designated as safety issue: No ]
Occurrence of solicited local (pain, redness and swelling) and general (irritability / fussiness, fever, drowsiness and loss of appetite) symptoms [ Time Frame: Within 4 days (Day 0 -Day 3) after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited symptoms. [ Time Frame: Within 31 days (Day 0 - Day 30) after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Throughout the entire study period. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	432
Study Start Date:	June 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group Hib-MenC: Experimental Subjects will receive Hib-MenC + Priorix™ vaccination at 12-18 months of age	Biological: Priorix™ One subcutaneous dose at 12-18 months of age Biological: Haemophilus influenzae type b and meningococcal serogroup C (vaccine) One intramuscular dose at 12-18 months of age
Group Hiberix: Active Comparator Subjects will receive Hiberix™ + MenC-CRM197 + Priorix™ vaccination at 12-18 months of age	Biological: Hiberix™ One intramuscular dose at 12-18 months of age. Biological: Meningitec™ One intramuscular dose at 12-18 months of age

Detailed Description:

This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase.

Eligibility

Ages Eligible for Study:	12 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Primary phase:

Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 18 months of age at the time of vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge.
Having completed primary vaccination with two doses of Hib-OMP containing vaccine OR three doses of DTPa/Hib containing vaccine at least 6 months before the study start.

Long-term persistence phase:

- Having participated in the vaccination study 106445

Exclusion Criteria:

For the primary vaccination phase:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination.
Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination.
Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose.
Previous administration of a booster dose of Hib vaccine.
Previous vaccination against measles, mumps, rubella.
History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases.
Known exposure to measles, mumps or rubella within 30 days prior to the start of the study.
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 neurological disorders or more than one episode of febrile convulsion.
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 long-term persistence phase: to be checked each year.

Previous administration of a booster dose of Hib, meningococcal serogroup C vaccines.
History of H. influenzae type b, meningococcal serogroup C diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326118

Locations

Australia, New South Wales
GSK Investigational Site
Woden, New South Wales, Australia, 2606
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4029
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Western Australia
GSK Investigational Site
Perth, Western Australia, Australia

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106445, 106454 (Y5), 106446 (Y1), 106449 (Y2), 106450 (Y3), 106452 (Y4)
Study First Received:	May 12, 2006
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00326118
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

H.influenzae type b diseases
Meningococcal serogroup C diseases

Study placed in the following topic categories:

Bacterial Infections
Haemophilus Infections
Haemophilus influenzae
Meningococcal Infections

Influenza, Human
Meningococcal infection
Neisseriaceae Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Pasteurellaceae Infections
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 14, 2009