Clinical trial NCT00345579: Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Official title: A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Keywords: Prophylaxis
Neisseria meningitidis Vaccines, conjugate
Infants
Meningococcal vaccines
H. influenzae type B vaccine
Humans
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 4432
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 primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Detailed description: Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

Eligibility criteria: Inclusion Criteria:

* Subjects for whom the investigator believes that parents/guardians 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 or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after 36 weeks gestation.
* 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 enrolment.
* Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion criteria:

Use of any investigational or non-registered product (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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
* In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, 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.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Primary outcomes:
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
measure: Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
timeFrame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
measure: Number of Subjects Reporting Rash
timeFrame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
measure: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)
timeFrame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
measure: Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
timeFrame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
measure: Number of Subjects With Rash
timeFrame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
measure: Number of Subjects With Adverse Events Resulting in Emergency Room (ER)
timeFrame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Benton
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Madera
country: United States
facility: GSK Investigational Site
state: California
city: Slinas
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Longmont
country: United States
facility: GSK Investigational Site
state: Colorado
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Oaklawn
country: United States
facility: GSK Investigational Site
state: Illinois
city: Waukee
country: United States
facility: GSK Investigational Site
state: Iowa
city: West Desmoines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Jamaica Plain
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Nies
country: United States
facility: GSK Investigational Site
state: Michigan
city: Portage
country: United States
facility: GSK Investigational Site
state: Michigan
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: St. Paul
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: New Hartford
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Clyde
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Deerfield
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Sylva
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: North Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: South Euclid
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Wexford
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Katy
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Ogden
country: United States
facility: GSK Investigational Site
state: Utah
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Pleasant Gorve
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.