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Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Meningococcal Infection; Haemophilus Infection

Intervention: Hib-MenCY-TT vaccine (MenHibrix) (Biological); Meningitec® (Biological); ActHIB® (Biological); Infanrix® Penta (Biological); Prevenar® (Biological); Mencevax® ACWY (Biological); PRP (Polyribosyl Ribitol Phosphate) (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

Clinical Details

Official title: A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome:

Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8

Secondary outcome:

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers

Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers

Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

Anti-polysaccharide C (PSC) Antibody Concentration

Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

Anti-polysaccharide Y (PSY) Antibody Concentration

Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

Anti-PRP Antibody Concentration

Number of Subjects Seroprotected for Anti-diphtheria Antibodies

Anti-diphtheria Antibody Concentrations

Number of Subjects Seroprotected for Anti-tetanus Antibodies

Anti-tetanus Antibody Concentrations

Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies

Anti- FHA Antibody Concentrations

Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies

Anti-PRN Antibody Concentrations

Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies

Anti- PT Antibody Concentrations

Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies

Anti- HBs Antibody Concentrations

Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies

Anti-poliovirus Types 1, 2 and 3 Antibody Titers

Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values

Anti-pneumococcal Antibody Concentrations

Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course

Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose

Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course

Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose

Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course

Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose

Detailed description: Evaluate immuno. (incl. immune memory),reacto & safety of 3 diff. formul. of GSKBio combined Haemophilus influenzae typeb-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix®penta DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumo. vaccine) vs ActHIB® (Hibvaccine) & Meningitec® (meningococcal serogroupC vaccine) given concomitantly with Infanrix®penta (DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumococcal vaccine)in infants according to a 2-4-6 mth schedule

Eligibility

Minimum age: 6 Weeks. Maximum age: 12 Weeks. Gender(s): Both.

Criteria:

Inclusion criteria:

- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the

time of the first 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.

- Vaccinated against hepatitis B at birth.

- Born after a gestation period of 36 - 42 weeks.

Exclusion criteria:

- Use of any investigational or non-registered 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 of immunosuppressants or other immune-modifying drugs since

birth

- Any chronic drug therapy to be continued during the study period.

- Planned administration/ administration of a vaccine not foreseen by the study

protocol within one month of the first dose of vaccine(s).

- Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis

of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.

- History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive

diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including

human immunodeficiency virus (HIV) infection.

- A family history of congenital or hereditary immunodeficiency.

- History of allergic disease or reactions likely to be exacerbated by any component of

the vaccines.

- 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.

Locations and Contacts

GSK Investigational Site, North Adelaide, South Australia 5006, Australia

GSK Investigational Site, Carlton, Victoria 3053, Australia

GSK Investigational Site, Subiaco, Western Australia 6018, Australia

Additional Information

Related publications:

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. Review.

Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. Epub 2007 Oct 25.

T Nolan et al. A novel Haemophilus influenzae type b - meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies' (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.

Starting date: March 2003
Last updated: June 15, 2012

Page last updated: August 20, 2015

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