Clinical trial NCT00345683: Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Official title: Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent 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: H. influenzae type B vaccine
Infants
Neisseria meningitidis
Vaccines, conjugate
Meningococcal vaccines
Prophylaxis
Comparative study
Safety
Humans
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 4021
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).

No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.

The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.

All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.

Note: This protocol posting deals with the objectives \& outcome measures for the booster phase of the study. The objectives \& outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

Eligibility criteria: Inclusion Criteria:

* Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study

Exclusion Criteria:

Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

* History of measles, mumps, rubella or varicella.
* Previous vaccination against measles, mumps, rubella or varicella.
* Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Patients receiving immunosuppressive therapy.
* Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Individuals with primary and acquired immunodeficiency states.
* Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* Individuals with active tuberculosis.
* Acute disease at time of booster vaccination

Primary outcomes:
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
measure: Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
timeFrame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
measure: Number of Subjects Reporting Rash
timeFrame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
measure: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
timeFrame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
measure: Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
timeFrame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
measure: Number of Subjects With Rash
timeFrame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
measure: Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits
timeFrame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
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: Jonesboro
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: 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: 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: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
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: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Boardman
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: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
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: 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: 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: 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: 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.