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

NCT ID: NCT00327184

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 709 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-11-30

Brief Summary

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.

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.

Conditions

Neisseria Meningitidis; Haemophilus Influenzae Type b

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)

Intervention Type: BIOLOGICAL

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

Infanrix Penta

Intervention Type: BIOLOGICAL

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

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.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa

Intervention Type: BIOLOGICAL

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Neis-Vac-C

Intervention Type: BIOLOGICAL

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Interventions

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.

Intervention Type: BIOLOGICAL

Infanrix Penta

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

Intervention Type: BIOLOGICAL

Infanrix hexa

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Intervention Type: BIOLOGICAL

Neis-Vac-C

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

Intervention Type: BIOLOGICAL

Eligibility 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.

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• 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

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kotka, , Finland

GSK Investigational Site

Lahti, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Vantaa, , Finland

GSK Investigational Site

Vantaa, , Finland

GSK Investigational Site

Bari, Apulia, Italy

GSK Investigational Site

Lodi, Lombardy, Italy

GSK Investigational Site

Sassari, Sardinia, Italy

GSK Investigational Site

Ragusa, Sicily, Italy

Countries

Finland; Italy

References

Vesikari T, Forsten A, Desole MG, Ferrera G, Caubet M, Mesaros N, Boutriau D. A combined Haemophilus influenzae 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. 2013 May;32(5):521-9. doi: 10.1097/INF.0b013e31827e22e3.

Reference Type: BACKGROUND

PMID: 23190785 (View on PubMed)

Study Documents

Document Type: Study Protocol

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

View Document

Document Type: Statistical Analysis Plan

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: Clinical Study Report

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: Individual Participant Data Set

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.

View Document

Related Links

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Other Identifiers

106390

Identifier Type: OTHER

Identifier Source: secondary_id

106388

Identifier Type: -

Identifier Source: org_study_id