Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 22, 2008
Last updated: August 8, 2013
Last verified: August 2013
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 Vaccines
Biological: Rotarix
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects. [ Time Frame: Two months after Dose 1. ] [ Designated as safety issue: No ]
  • Seroconversion rates to anti-rotavirus IgA antibody [ Time Frame: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects). ] [ Designated as safety issue: No ]
  • Vaccine take rates in a subset of subjects. [ Time Frame: Two months after each dose ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • For each type of solicited symptom, occurrence of the symptom [ Time Frame: During the 8-day follow-up period after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the study period. ] [ Designated as safety issue: No ]

Enrollment: 854
Study Start Date: August 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group HRV Lot A Biological: Rotarix
Two oral doses.
Experimental: Group HRV Lot B Biological: Rotarix
Two oral doses.
Experimental: Group HRV Lot C Biological: Rotarix
Two oral doses.
Active Comparator: Group Placebo Biological: Placebo
Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.


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

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
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Please refer to this study by its identifier: NCT00757770

GSK Investigational Site
Lima, Peru, Lima
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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.

Responsible Party: GlaxoSmithKline Identifier: NCT00757770     History of Changes
Other Study ID Numbers: 444563/033 
Study First Received: September 22, 2008
Last Updated: August 8, 2013
Health Authority: Mexico: Ministry of Health

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on August 25, 2016