Clinical trial NCT00757770: Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
Official title: Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 854
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 lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* 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.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

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.
* Child is unlikely to remain in the study area for the duration of the study.
* Previous confirmed occurrence of rotavirus gastroenteritis.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Household contact with an immunosuppressed individual or pregnant woman.
* Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
* Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Primary outcomes:
measure: Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
timeFrame: Two months after Dose 2.
Secondary outcomes:
measure: Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.
timeFrame: Two months after Dose 1.
measure: Seroconversion rates to anti-rotavirus IgA antibody
timeFrame: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).
measure: Vaccine take rates in a subset of subjects.
timeFrame: Two months after each dose
measure: Presence of rotavirus in stool samples in a subset of subjects
timeFrame: On the day of each vaccination and on planned days following each vaccination.
measure: For each type of solicited symptom, occurrence of the symptom
timeFrame: During the 8-day follow-up period after each vaccine dose
measure: Occurrence of unsolicited symptoms
timeFrame: During the 31-day follow-up period after each vaccine dose.
measure: Occurrence of serious adverse events
timeFrame: Throughout the study period.
Other outcomes:
Locations:
city: Cali Colombia
country: Colombia
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lopez P, Herrera JFG, Cervantes Y, et al. Three consecutive production lots of the human monovalent RIX4414 G1P(8) rotavirus vaccine, Rotarix™ induce a consistent immune response in Latin American infants. Proc 4th World Congress Pediatr Infect Dis, Warsaw, Poland, 2005.