Infections, RotavirusPhase 3NCT00757770
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
A Phase 3 study testing Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Rotarix
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 854 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2003to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Location not given1 site
GSK Investigational Site
About this 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
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.
- Conditions
- Infections, Rotavirus
- Being tested
- Rotarix, Placebo
- Keywords
- Gastroenteritis
- Medical subject headings
- Rotavirus Infections, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotarixBiological
Two oral doses.
PlaceboBiological
Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.
| Study group | Role | What they receive |
|---|---|---|
| Group HRV Lot A | Experimental | Not described Receives: Biological: Rotarix |
| Group HRV Lot B | Experimental | Not described Receives: Biological: Rotarix |
| Group HRV Lot C | Experimental | Not described Receives: Biological: Rotarix |
| Group Placebo | Active comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
Measured: Two months after Dose 2.
Secondary outcomes (7)
Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.
Measured: Two months after Dose 1.
Seroconversion rates to anti-rotavirus IgA antibody
Measured: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).
Vaccine take rates in a subset of subjects.
Measured: Two months after each dose
Presence of rotavirus in stool samples in a subset of subjects
Measured: On the day of each vaccination and on planned days following each vaccination.
For each type of solicited symptom, occurrence of the symptom
Measured: During the 8-day follow-up period after each vaccine dose
Occurrence of unsolicited symptoms
Measured: During the 31-day follow-up period after each vaccine dose.
Occurrence of serious adverse events
Measured: Throughout the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startAug 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 854 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757770
- Sponsor's protocol ID
- 444563/033
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2008
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00757770
- Acronym / sponsor ID
- 444563/033
- Conditions
- Infections, Rotavirus
- Keywords
- Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 854 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group HRV Lot A | Experimental | Biological: Rotarix |
| Group HRV Lot B | Experimental | Biological: Rotarix |
| Group HRV Lot C | Experimental | Biological: Rotarix |
| Group Placebo | Active comparator | Biological: Placebo |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RotarixTwo oral doses. | Biological | Group HRV Lot A, Group HRV Lot B, Group HRV Lot C |
| PlaceboTwo oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles. | Biological | Group Placebo |
Primary outcome
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
Time frame: Two months after Dose 2.
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Results publicationLopez 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Mexico, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs). (time frame: Two months after Dose 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.