Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00757770

Purpose

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.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: Rotarix Biological: Placebo	Phase III

MedlinePlus related topics: Gastroenteritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs). [ Time Frame: Two months after Dose 2. ]

Secondary Outcome Measures:

Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects. [ Time Frame: Two months after Dose 1. ]
Seroconversion rates to anti-rotavirus IgA antibody [ Time Frame: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects). ]
Vaccine take rates in a subset of subjects. [ Time Frame: Two months after each dose ]
Presence of rotavirus in stool samples in a subset of subjects [ Time Frame: On the day of each vaccination and on planned days following each vaccination. ]
For each type of solicited symptom, occurrence of the symptom [ Time Frame: During the 8-day follow-up period after each vaccine dose ]
Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccine dose. ]
Occurrence of serious adverse events [ Time Frame: Throughout the study period. ]

Enrollment:	854
Study Start Date:	August 2003
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group HRV Lot A: Experimental	Biological: Rotarix Two oral doses.
Group HRV Lot B: Experimental	Biological: Rotarix Two oral doses.
Group HRV Lot C: Experimental	Biological: Rotarix Two oral doses.
Group Placebo: Active Comparator	Biological: Placebo Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

Eligibility

Ages Eligible for Study:	6 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757770

Locations

Colombia
Clinical Trials Call Center
Colombia, Colombia
Mexico
GSK Clinical Trials Call Center
Mexico, Mexico
Peru
GSK Clinical Trials Call Center
Lima, Peru

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	444563/033
Study First Received:	September 22, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00757770 History of Changes
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by GlaxoSmithKline:

Gastroenteritis

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Healthy
Gastroenteritis

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009