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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00757770
First received: September 22, 2008
Last updated: August 8, 2013
Last verified: August 2013
  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 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
na
Biological: Rotarix
Two oral doses.
Experimental: Group HRV Lot B
na
Biological: Rotarix
Two oral doses.
Experimental: Group HRV Lot C
na
Biological: Rotarix
Two oral doses.
Active Comparator: Group Placebo
na
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
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
ClinicalTrials.gov 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:
Gastroenteritis

ClinicalTrials.gov processed this record on August 26, 2014