Infections, RotavirusPhase 2NCT00263666
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
A Phase 2 study testing Rotarix, Tritanrix-HB+Hib and Polio Sabin in people with Infections, Rotavirus, run by GlaxoSmithKline at 6 sites in South Africa.
Trial summary
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. 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 10 weeks
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Rotarix, Tritanrix-HB+Hib and Polio Sabin
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesSouth Africa
- Study dates
- 16 Mar 2005to 13 Feb 2008
- Phase
- Phase 2
- 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 10 weeks
- All sexes
- No healthy volunteers
- 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 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents or guardians of the subject
- Documented HIV status of the subject as confirmed by PCR.
- HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
- Born after a gestation period of 36 to 42 weeks.
Who cannot join
- Use of any investigational or non-registered 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.
- Previous routine vaccination except OPV, BCG and HBV vaccination at birth
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
Show all 10Show fewer
- Previous confirmed occurrence of RV gastroenteritis.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Africa6 sites
GSK Investigational Site
Attridgerville, Gauteng, 0008
GSK Investigational Site
Brits, 0250
GSK Investigational Site
Capital Park, 0002
GSK Investigational Site
Coronationville, Gauteng, 2112
GSK Investigational Site
Ga-Rankuwa, 0208
GSK Investigational Site
Garankuwa, North West, 0204
About this study
Official title: A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.
- Conditions
- Infections, Rotavirus
- Being tested
- Rotarix, Placebo, Tritanrix-HB+Hib, Polio Sabin
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotarixBiological
Oral vaccination
PlaceboBiological
Oral administration
Tritanrix-HB+HibBiological
Concomitant routine vaccination, IM administration
Polio SabinBiological
Oral administration, concomitant routine vaccination
| Study group | Role | What they receive |
|---|---|---|
| Rotarix Group | Experimental | Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines. Receives: Biological: Rotarix; Biological: Tritanrix-HB+Hib; Biological: Polio Sabin |
| Placebo Group | Placebo comparator | Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines. Receives: Biological: Placebo; Biological: Tritanrix-HB+Hib; Biological: Polio Sabin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea
Symptoms reported in the table include: Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.
Measured: Within the 15-day solicited follow-up period after any dose
Secondary outcomes (23)
Number of Subjects Reporting Any Unsolicited Symptoms
An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Within 30 days after any dose
Number of Subjects Reporting Any Serious Adverse Events
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: Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3)
Number of Subjects Reporting Each Type of Solicited Symptom
Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.
Measured: Within the 15-day solicited follow-up period after each dose
The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent
Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.
Measured: At the screening visit and 2 months after dose 3 (Visit 4)
Human Immunodeficiency Virus (HIV) Viral Load
The HIV viral load was expressed as mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).
Measured: At the screening visit and 2 months after dose 3
Number of Subjects Who Seroconverted Against Rotavirus
A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.
Measured: Two months after dose 3
Number of Subjects With Vaccine Take
Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.
Measured: Two months after dose 3
Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations
Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.
Measured: Two months after dose 3
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value
Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).
Measured: Two months after dose 3
Geometric Mean Concentration for Anti-PRP Antibodies
Anti-PRP antibody concentrations are presented as geometric mean concentrations, expressed in microgram/milliliter (μg/mL).
Measured: Two months after dose 3
Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value
The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL).
Measured: Two months after dose 3
Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies
Anti-diphteria and anti-tetanus toxoids antibody concentrations are presented as geometric mean concentrations, expressed in international units/milliliter (IU/mL).
Measured: Two months after dose 3
Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value
The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).
Measured: Two months after dose 3
Geometric Mean Concentration for Anti-HBs Antibodies
Anti-HBs antibody concentrations are presented as geometric mean concentrations, expressed in milli international units/milliliter (mIU/mL).
Measured: Two months after dose 3
Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value
The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter (EL.U/mL).
Measured: Two months after dose 3
Geometric Mean Concentration for Anti-BPT Antibodies
Anti-BPT antibody concentrations are presented as geometric mean concentrations, expressed in ELISA units/milliliter (EL.U/mL).
Measured: Two months after dose 3
Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value
The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.
Measured: Two months after dose 3
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.
Anti-polio types 1, 2 and 3 antibody titers are presented as geometric mean titers.
Measured: Two months after dose 3
Rotavirus Antigen Excretion in Stool Samples
Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end.
Measured: At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding
Rotavirus in Diarrheal Stool Samples
Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.
Measured: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Rotavirus Vaccine Strain Identification
Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype. Unknown: These samples were typed post hoc and found "G1P8" vaccine type for one subject in HRV group, "G3P8" and "G2P4" for subjects in placebo group.
Measured: From dose 1 until 2 months after dose 3 or until end of RV shedding
Enteric Pathogens Identification
Number of subjects reporting gastroenteritis (GE) episodes classified by enteric pathogen tests results.
Measured: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Number of Subjects With the RV in Stool Samples
Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type = G1V+G1WT+G2+G3+P4+P8V+P8WT and results not available [NA]).
Measured: From Dose 1 until post Dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study start16 Mar 2005
- Primary completion7 Feb 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 (3)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- NCT00263666
- Sponsor's protocol ID
- 444563/022
- Other IDs
- 2015-001484-39, 2015
- Status last verified
- Oct 2020
- First submitted
- 8 Dec 2005
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
PubMed 24047799Steele AD, Madhi SA, Louw CE, Bos P, Tumbo JM, Werner CM, Bicer C, De Vos B, Delem A, Han HH. Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa. Pediatr Infect Dis J. 2011 Feb;30(2):125-30. doi: 10.1097/INF.0b013e3181f42db9.
PubMed 20842070Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.
PubMed 16394298
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
- ClinicalTrials.gov ID
- NCT00263666
- Acronym / sponsor ID
- 444563/022
- Conditions
- Infections, Rotavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2005 (actual)
- Primary completion
- 7 Feb 2008 (actual)
- Study completion
- 13 Feb 2008 (actual)
- First posted
- 9 Dec 2005 (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 evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotarix Group | Experimental | Biological: Rotarix, Biological: Tritanrix-HB+Hib, Biological: Polio SabinSubjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines. |
| Placebo Group | Placebo comparator | Biological: Placebo, Biological: Tritanrix-HB+Hib, Biological: Polio SabinSubjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines. |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 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 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents or guardians of the subject
- Documented HIV status of the subject as confirmed by PCR.
- HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
Key exclusion criteria (10 listed)
- Use of any investigational or non-registered 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.
- Previous routine vaccination except OPV, BCG and HBV vaccination at birth
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- History of allergic disease or reaction 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 |
|---|---|---|
| RotarixOral vaccination | Biological | Rotarix Group |
| PlaceboOral administration | Biological | Placebo Group |
| Tritanrix-HB+HibConcomitant routine vaccination, IM administration | Biological | Placebo Group, Rotarix Group |
| Polio SabinOral administration, concomitant routine vaccination | Biological | Placebo Group, Rotarix Group |
Primary outcome
Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea
Time frame: Within the 15-day solicited follow-up period after any dose
Symptoms reported in the table include: Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.
23 secondary outcomes
Number of Subjects Reporting Any Unsolicited Symptoms
Time frame: Within 30 days after any dose
Number of Subjects Reporting Any Serious Adverse Events
Time frame: Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3)
Number of Subjects Reporting Each Type of Solicited Symptom
Time frame: Within the 15-day solicited follow-up period after each dose
The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent
Time frame: At the screening visit and 2 months after dose 3 (Visit 4)
Human Immunodeficiency Virus (HIV) Viral Load
Time frame: At the screening visit and 2 months after dose 3
Number of Subjects Who Seroconverted Against Rotavirus
Time frame: Two months after dose 3
Number of Subjects With Vaccine Take
Time frame: Two months after dose 3
Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations
Time frame: Two months after dose 3
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value
Time frame: Two months after dose 3
Geometric Mean Concentration for Anti-PRP Antibodies
Time frame: Two months after dose 3
Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value
Time frame: Two months after dose 3
Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies
Time frame: Two months after dose 3
Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value
Time frame: Two months after dose 3
Geometric Mean Concentration for Anti-HBs Antibodies
Time frame: Two months after dose 3
Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value
Time frame: Two months after dose 3
Geometric Mean Concentration for Anti-BPT Antibodies
Time frame: Two months after dose 3
Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value
Time frame: Two months after dose 3
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.
Time frame: Two months after dose 3
Rotavirus Antigen Excretion in Stool Samples
Time frame: At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding
Rotavirus in Diarrheal Stool Samples
Time frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Rotavirus Vaccine Strain Identification
Time frame: From dose 1 until 2 months after dose 3 or until end of RV shedding
Enteric Pathogens Identification
Time frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding
Number of Subjects With the RV in Stool Samples
Time frame: From Dose 1 until post Dose 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24047799Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
- Background: PubMed 20842070Steele AD, Madhi SA, Louw CE, Bos P, Tumbo JM, Werner CM, Bicer C, De Vos B, Delem A, Han HH. Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa. Pediatr Infect Dis J. 2011 Feb;30(2):125-30. doi: 10.1097/INF.0b013e3181f42db9.
- Derived from this study: PubMed 16394298Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.
- 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.
Related trials for Infections, Rotavirus
Active, not recruitingPhase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
Rotavirus Infections
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Rotavirus Infection of Children
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rotarix, Tritanrix-HB+Hib and Polio Sabin in people with Infections, Rotavirus, run by GlaxoSmithKline at 6 sites in South Africa.
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 6 inclusion and 10 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Africa. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea (time frame: Within the 15-day solicited follow-up period after any dose). 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 NCT00263666, which also lists 3 linked publications.
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 23 Nov 2020.