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

NCT ID: NCT00326118

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-01
• Study Completion Date: 2007-11-06

Brief Summary

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.

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.

Conditions

Haemophilus Influenzae Type b; Neisseria Meningitidis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Meningitec + Hiberix Group

Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Group Type: ACTIVE_COMPARATOR

Priorix™

Intervention Type: BIOLOGICAL

One subcutaneous dose at 12-18 months of age

Hiberix™

Intervention Type: BIOLOGICAL

One intramuscular dose at 12-18 months of age.

Meningitec™

Intervention Type: BIOLOGICAL

One intramuscular dose at 12-18 months of age

Menitorix Group

Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.

Group Type: EXPERIMENTAL

Haemophilus influenzae type b and meningococcal serogroup C (vaccine)

Intervention Type: BIOLOGICAL

One intramuscular dose at 12-18 months of age

Priorix™

Intervention Type: BIOLOGICAL

One subcutaneous dose at 12-18 months of age

Interventions

Haemophilus influenzae type b and meningococcal serogroup C (vaccine)

One intramuscular dose at 12-18 months of age

Intervention Type: BIOLOGICAL

Priorix™

One subcutaneous dose at 12-18 months of age

Intervention Type: BIOLOGICAL

Hiberix™

One intramuscular dose at 12-18 months of age.

Intervention Type: BIOLOGICAL

Meningitec™

One intramuscular dose at 12-18 months of age

Intervention Type: BIOLOGICAL

Other Intervention Names

Hib-MenC; Menitorix™

Eligibility 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 Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (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.

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Garran, Australian Capital Territory, Australia

GSK Investigational Site

Randwick, New South Wales, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

Herston, Queensland, Australia

GSK Investigational Site

North Adelaide, South Australia, Australia

GSK Investigational Site

Carlton, Victoria, Australia

GSK Investigational Site

Perth, Western Australia, Australia

Countries

Australia

References

Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Heron L, Lambert S, Caubet M, Mesaros N, Boutriau D. Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. Pediatr Infect Dis J. 2011 Apr;30(4):340-2. doi: 10.1097/INF.0b013e31820013d2.

Reference Type: BACKGROUND

PMID: 21068692 (View on PubMed)

Booy R, Richmond P, Nolan T, McVernon J, Marshall H, Nissen M, Reynolds G, Ziegler JB, Stoney T, Heron L, Lambert S, Mesaros N, Peddiraju K, Miller JM. Three-year antibody persistence and safety after a single dose of combined haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in Hib-primed toddlers. Pediatr Infect Dis J. 2013 Feb;32(2):169-74. doi: 10.1097/INF.0b013e3182787bff.

Reference Type: BACKGROUND

PMID: 23080288 (View on PubMed)

Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 3 year follow-up. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.

Reference Type: BACKGROUND

Booy R et al. Immunogenicity and safety of the Hib-MenC-TT conjugate vaccine in Hib-primed toddlers: 4 year follow-up. Abstract presented at the Communicable Diseases Network Australia - Communicable Diseases Control Conference 2013, Canberra, Australia, 19-20 March 2013.

Reference Type: BACKGROUND

Booy R et al. Prolonged immunogenicity and safety of the HibMenC-TT conjugate vaccine in Hib-Primed toddlers. Abstract presented at the PHAA Communicable Disease Conference. Canberra, Australia, 4-6 April 2011.

Reference Type: BACKGROUND

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

106446

Identifier Type: OTHER

Identifier Source: secondary_id

106449

Identifier Type: OTHER

Identifier Source: secondary_id

106450

Identifier Type: OTHER

Identifier Source: secondary_id

106452

Identifier Type: OTHER

Identifier Source: secondary_id

106454

Identifier Type: OTHER

Identifier Source: secondary_id

106445

Identifier Type: -

Identifier Source: org_study_id