Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00757770
First received: September 22, 2008
Last updated: May 16, 2013
Last verified: May 2013
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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 |
Resource links provided by NLM:
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 More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00757770 History of Changes |
| Other Study ID Numbers: | 444563/033 |
| Study First Received: | September 22, 2008 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by GlaxoSmithKline:
|
Gastroenteritis |
ClinicalTrials.gov processed this record on May 23, 2013