Infections, RotavirusPhase 3NCT00396630
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
A Phase 3 study testing Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 1 site in Dominican Republic.
Trial summary
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study
- Who is it for?
- Ages 6 to 14 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
- 200 participants
- Where
- 1 siteDominican Republic
- Study dates
- 23 Jan 2007to 13 Feb 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects with a live twin living in the same household who is also enrolled in this study.
- Born after a gestation period of ≥32 weeks,
- Discharged from hospital neonatal care stay,
- 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 14 weeks of age at the time of the first study vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parent or guardian of the subjects.
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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Any clinically significant history of chronic gastrointestinal disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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- Contact with an immunosuppressed individual.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration of immunosuppressants since birth.
- Gastroenteritis within 7 days preceding the first study vaccine administration.
- Documented HIV-positive subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.
One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.
The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.
The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
- Conditions
- Infections, Rotavirus
- Being tested
- Rotarix, Placebo
- Keywords
- Transmission, Gastroenteritis, Shedding, rotavirus, HRV vaccine
- 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-dose oral vaccination.
PlaceboBiological
Two-dose oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Rotarix Group | Experimental | All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). Receives: Biological: Rotarix |
| Placebo Group | Placebo comparator | All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). Receives: Biological: Rotarix; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
Measured: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Secondary outcomes (8)
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.
Measured: From Day 0 up to Week 13.
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.
Measured: During the entire study period (up to Visit 4, Week 17).
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.
Measured: During the entire study period (up to Visit 4, Week 17).
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.
Measured: At Visit 3 (Week 13).
Anti-rotavirus IgA Antibody Concentration.
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.
Measured: At Visit 3 (Week 13).
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.
RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA).
Measured: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Within 31 days after any doses.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Up to Visit 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study start23 Jan 2007
- Primary completion23 Jan 2008
- Study completion13 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT00396630
- Sponsor's protocol ID
- 106260
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2006
- Last updated
- 6 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
Rivera L, Pena LM, Stainier I, Gillard P, Cheuvart B, Smolenov I, Ortega-Barria E, Han HH. Horizontal transmission of a human rotavirus vaccine strain--a randomized, placebo-controlled study in twins. Vaccine. 2011 Nov 28;29(51):9508-13. doi: 10.1016/j.vaccine.2011.10.015. Epub 2011 Oct 18.
PubMed 22008819
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
- ClinicalTrials.gov ID
- NCT00396630
- Acronym / sponsor ID
- 106260
- Conditions
- Infections, Rotavirus
- Keywords
- Transmission, Gastroenteritis, Shedding, rotavirus, HRV vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2007 (actual)
- Primary completion
- 23 Jan 2008 (actual)
- Study completion
- 13 Feb 2008 (actual)
- First posted
- 7 Nov 2006 (estimated)
- Results
- Posted 13 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.
One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.
The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.
The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotarix Group | Experimental | Biological: RotarixAll subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
| Placebo Group | Placebo comparator | Biological: Rotarix, Biological: PlaceboAll subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3). |
Who may qualify
- Ages
- 6 to 14 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects with a live twin living in the same household who is also enrolled in this study.
- Born after a gestation period of ≥32 weeks,
- Discharged from hospital neonatal care stay,
- 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 14 weeks of age at the time of the first study vaccination.
Key exclusion criteria (11 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Any clinically significant history of chronic gastrointestinal disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
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-dose oral vaccination. | Biological | Placebo Group, Rotarix Group |
| PlaceboTwo-dose oral administration. | Biological | Placebo Group |
Primary outcome
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
Time frame: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
8 secondary outcomes
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
Time frame: From Day 0 up to Week 13.
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
Time frame: During the entire study period (up to Visit 4, Week 17).
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
Time frame: During the entire study period (up to Visit 4, Week 17).
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
Time frame: At Visit 3 (Week 13).
Anti-rotavirus IgA Antibody Concentration.
Time frame: At Visit 3 (Week 13).
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
Time frame: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Time frame: Within 31 days after any doses.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Time frame: Up to Visit 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22008819Rivera L, Pena LM, Stainier I, Gillard P, Cheuvart B, Smolenov I, Ortega-Barria E, Han HH. Horizontal transmission of a human rotavirus vaccine strain--a randomized, placebo-controlled study in twins. Vaccine. 2011 Nov 28;29(51):9508-13. doi: 10.1016/j.vaccine.2011.10.015. Epub 2011 Oct 18.
- 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
1 site in 1 country: 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 1 site in Dominican Republic.
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 7 inclusion and 11 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. (time frame: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.). 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 NCT00396630, 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 6 Feb 2018.