3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

NCT ID: NCT00129116

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-01
• Study Completion Date: 2003-12-16

Brief Summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.

Detailed Description

Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule

Conditions

Haemophilus Influenzae Type b; Neisseria Meningitidis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Menhibrix F1/Infanrix-penta Group

Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Group Type: EXPERIMENTAL

Hib-MenCY-TT vaccine

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Infanrix penta ®

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Menhibrix F2/Infanrix-penta Group

Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Group Type: EXPERIMENTAL

Hib-MenCY-TT vaccine

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Infanrix penta ®

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Menhibrix F3/Infanrix-penta Group

Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Group Type: EXPERIMENTAL

Hib-MenCY-TT vaccine

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Infanrix penta ®

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Menitorix/Infanrix-penta Group

Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Group Type: EXPERIMENTAL

Hib-MenC-TT vaccine

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Infanrix penta ®

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Menjugate/Infanrix-hexa Group

Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Group Type: ACTIVE_COMPARATOR

Menjugate ®

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Infanrix hexa ®

Intervention Type: BIOLOGICAL

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Interventions

Hib-MenCY-TT vaccine

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Intervention Type: BIOLOGICAL

Hib-MenC-TT vaccine

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Intervention Type: BIOLOGICAL

Menjugate ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

Intervention Type: BIOLOGICAL

Infanrix penta ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Intervention Type: BIOLOGICAL

Infanrix hexa ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa-HBV-IPV vaccine; DTPa-HBV-IPV/Hib vaccine

Eligibility Criteria

Inclusion Criteria

• Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.

Exclusion Criteria

• Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.

• 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

Asse, , Belgium

GSK Investigational Site

Drongen, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Maldegem, , Belgium

GSK Investigational Site

Merelbeke, , Belgium

GSK Investigational Site

Oudenaarde, , Belgium

GSK Investigational Site

Sint-Amandsberg, , Belgium

GSK Investigational Site

Cham, Bavaria, Germany

GSK Investigational Site

Kaufering, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Olching, Bavaria, Germany

GSK Investigational Site

Niedernhausen, Hesse, Germany

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

GSK Investigational Site

Kirchlengern, North Rhine-Westphalia, Germany

GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

Countries

Belgium; Germany

References

Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.

Reference Type: BACKGROUND

PMID: 21806393 (View on PubMed)

Habermehl P, Leroux-Roels G, Sanger R, Machler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51. doi: 10.4161/hv.6.8.12154.

Reference Type: BACKGROUND

PMID: 20697200 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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: 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: Study Protocol

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

View Document

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Other Identifiers

100381

Identifier Type: OTHER

Identifier Source: secondary_id

792014/003

Identifier Type: -

Identifier Source: org_study_id