Clinical trial NCT01978093: Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Official title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine 792014 Compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Vaccine in Healthy Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Haemophilus Influenzae Type b
Keywords: Conjugate
Immunogenicity
Hib-MenCY-TT vaccine
Haemophilus type b
Safety
Reactogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 600
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 evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.


Eligibility criteria: Inclusion Criteria:

* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive).
* Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. Inhaled and topical steroids are allowed.
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine.
* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Major congenital defects or serious chronic illnesses.
* History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed.
* Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions.
* Acute disease and/or fever at the time of enrollment.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.

Primary outcomes:
measure: Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL
timeFrame: 1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]
measure: Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).
timeFrame: 2 months post-dose 2 of Rotarix (Month 4)
measure: Anti-Streptococcus (S) Pneumoniae GMCs
timeFrame: 1 month post-dose 3 of Prevnar 13 (Month 5)
measure: Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL
timeFrame: 1 month post-dose 2 of Havrix (Month 17-20)
measure: Anti-S. Pneumoniae GMCs
timeFrame: 1 month post-dose 4 of Prevnar 13 (Month 11-14)
Secondary outcomes:
measure: Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.
timeFrame: 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]
measure: Anti-PRP GMCs≥ 0.15 µg/mL.
timeFrame: 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]
measure: Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL
timeFrame: 2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].
measure: Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.
timeFrame: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).
measure: Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY
timeFrame: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).
measure: Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL
timeFrame: 2 month post-dose 2 of Rotarix (Month 4)
measure: Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL
timeFrame: 1 month post-dose 1 of Havrix (Month 11-14)
measure: Anti-HAV GMCs ≥ 15 mIU/mL
timeFrame: 1 month post-dose 1 of HAV (M11-14).
measure: GMCs for Anti-HAV Antibodies ≥15mIU/mL.
timeFrame: 1 month post-dose 2 of HAV (Month 17-20).
measure: Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
timeFrame: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)
measure: Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).
timeFrame: 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose
measure: Percentage of Subjects Reporting Any Solicited General AEs.
timeFrame: 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.
measure: Percentage of Subjects Reporting Any Unsolicited AEs.
timeFrame: During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)
measure: Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).
timeFrame: During the entire study period (from Day 0 to Month 17-20)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
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facility: GSK Investigational Site
state: California
city: Paramount
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facility: GSK Investigational Site
state: California
city: Pleasanton
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Santa Clara
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Woburn
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Niles
country: United States
facility: GSK Investigational Site
state: Michigan
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Hermitage
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: