Last updated: 11/04/2018 02:46:40
Assessment of clinical consistency of three production lots of GSK Biologicals' HRV vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
Timeframe: Two months after Dose 2.
Secondary outcomes:
Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.
Timeframe: Two months after Dose 1.
Seroconversion rates to anti-rotavirus IgA antibody
Timeframe: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).
Vaccine take rates in a subset of subjects.
Timeframe: Two months after each dose
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.
For each type of solicited symptom, occurrence of the symptom
Timeframe: During the 8-day follow-up period after each vaccine dose
Occurrence of unsolicited symptoms
Timeframe: During the 31-day follow-up period after each vaccine dose.
Occurrence of serious adverse events
Timeframe: Throughout the study period.
Interventions:
Biological/vaccine: Rotarix
Biological/vaccine: Placebo
Enrollment:
854
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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.
Buyse H et al. (2013) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1). [Epub ahead of print]
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
August 2003 to January 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-31-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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