Clinical trial NCT00258700: Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine
Official title: Demonstrate Non-inferiority of Men-C Immune Response of Hib-MenC With Infanrix™-IPV Versus a Licensed Men-C Vaccine With Pediacel™ When Given at 2, 3, 4 Months and the Immunogenicity of Hib-MenC When Given as a Booster Dose at 12-15 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 478
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.

Detailed description: This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). The study will be conducted in two stages. Primary vaccination phase: 3 doses Hib-MenC-TT with Infanrix™-IPV or for the control group a licensed Men-C vaccine with Pediacel™ at 2, 3, 4 months of age; Booster/persistence phase: 1 dose Hib-MenC with Priorix™. 4 blood samples of 3.5ml (5ml for the UK subset) are collected (Study Months 0 \& 3, prior to \& 42 days after the booster).

Eligibility criteria: Inclusion criteria:

* Healthy male or female, between, and including, 6 and 12 weeks of age.
* Born after a gestation period between 36 and 42 weeks
* Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory

Exclusion criteria:

* Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines.
* History of H. influenzae type b and /or meningococcal serogroup C disease.
* Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* A family history of congenital or hereditary immunodeficiency
* History of any neurologic disorders or seizures
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Primary outcomes:
measure: 1 m after the 3rd dose of primary vaccination: SBA-MenC titre ≥ 1:8 (seroprotection status), anti-PRP concentration ≥ 0.15 µg/ml. 42 d after the booster vaccination: SBA-MenC titre ≥ 1:128, anti-PRP concentration ≥ 1 μg/ml
Secondary outcomes:
measure: Antibody levels to all vaccine antigens:1 m post dose 3, prior to & 42 d post booster. After each dose: Solicited (d 0-3, local & general), unsolicited (d 0-30) & MMR specific (d 0-42) symptoms. SAEs (whole study).
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Leczna
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Trzebnica
country: Poland
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pace D, Snape M, Westcar S, Oluwalana C, Yu LM, Begg N, Wysocki J, Czajka H, Maechler G, Boutriau D, Pollard AJ. A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial. Arch Dis Child. 2008 Nov;93(11):963-70. doi: 10.1136/adc.2007.136036. Epub 2008 May 7.