Clinical trial NCT00334607: Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Official title: Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: HRV vaccine
diarrhoea
rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-08
Enrollment: 484
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.

Detailed description: A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).

Eligibility criteria: Inclusion Criteria:

* Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components;
* clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
* immunocompromised.

Primary outcomes:
measure: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Secondary outcomes:
measure: Assess immunogenicity and safety of HRV vaccine.
Other outcomes:
Locations:
city: Benton
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Cabot
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: North Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Lakewood
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Englewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: DeKalb
country: United States
facility: GSK Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
city: Commerce Twp
country: United States
facility: GSK Investigational Site
state: Michigan
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Bryson
country: United States
facility: GSK Investigational Site
state: North Carolina
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: Franklin
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Laurinburg
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Boardman
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: GSK Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bryan
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
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: Provo
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: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008 Nov;122(5):e1062-6. doi: 10.1542/peds.2008-1059.