Clinical trial NCT00363545: To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Official title: A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: Prophylaxis against gastroenteritis caused by Rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 1274
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: This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine


Eligibility criteria: Inclusion Criteria:

* Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
* Concurrently participating 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).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Household contact with an immunosuppressed individual or pregnant women.
* Previous confirmed occurrence of RV GE.

Primary outcomes:
measure: Number of Seroconverted Subjects Against Human Rotavirus
timeFrame: At 1 to 2 months after the second vaccine dose (Months 3-4)
Secondary outcomes:
measure: Concentrations of Anti-rotavirus IgA Antibodies
timeFrame: At 1 to 2 months after the second vaccine dose (Months 3-4)
measure: Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies
timeFrame: At 1 to 2 months after the second vaccine dose (Months 3-4)
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the entire study period (from Day 0 to Month 4)
measure: Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes
timeFrame: From the first vaccine dose (Dose 1) up to Month 4
Other outcomes:
Locations:
city: David
country: Panama
facility: GSK Investigational Site
city: La Chorrera
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.