RotavirusPhase 3NCT02141204
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
A Phase 3 study testing HRV Liquid and HRV Lyophilized in people with Rotavirus, run by GlaxoSmithKline at 8 sites in India.
Trial summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose one, with no previous history of rotavirus… Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus
- What is being tested?
- HRV Liquid and HRV Lyophilized
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 8 sitesIndia
- Study dates
- 20 Feb 2019to 28 Dec 2019
- 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 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects' parent(s)/ Legally Acceptable Representative (s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any study specific procedure.
- A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Birth weight >2000 grams.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccine (Day-29 to Day 1), or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of any chronic drug therapy to be continued during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3; with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations, according to the local immunization practice.
- 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.
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- History of confirmed RV GE.
- Previous vaccination against RV.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency [SCID] disorder) based on medical history and physical examination.
- Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
- History of IS.
- Very prematurely born infants (born ≤28 weeks of gestation).
- Hypersensitivity to latex.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment. This warrants deferral of vaccination.
- Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla or the rectum.
- Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
- GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
GSK Investigational Site
Bangalore, 560002
GSK Investigational Site
Kolkata, 700017
GSK Investigational Site
Ludhiana, 141 008
GSK Investigational Site
Mumbai, 400012
GSK Investigational Site
Pune, 411 011
GSK Investigational Site
Pune
GSK Investigational Site
Vellore, 632002
GSK Investigational Site
Vellore, 632004
About this study
Official title: Immunogenicity and Safety Study of Two Different Formulations of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, Rotarix in Healthy Infants
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose one, with no previous history of rotavirus illness or vaccination.
While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008, this study is conducted to generate additional clinical data for the liquid formulation of the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines (NDAC-Vaccines) of Drug Controller General of India (DCGI).
- Conditions
- Rotavirus
- Being tested
- HRV Liquid, HRV Lyophilized
- Keywords
- Rotarix, HRV, Healthy infants, Liquid formulation, Lyophilized formulation, Human rotavirus vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV LiquidBiological
Two doses administered orally according to a 0, 1-month schedule.
HRV LyophilizedBiological
Two doses administered orally according to a 0, 1-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| HRV Liq Group | Experimental | Subjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. Receives: Biological: HRV Liquid |
| HRV Lyo Group | Active comparator | Subjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. Receives: Biological: HRV Lyophilized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations
Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).
Measured: At Month 2
Secondary outcomes (4)
Percentage of Seroconverted Subjects for Anti-RV IgA Antibodies
Seroconversion is defined as: - for subjects with a pre-vaccination anti-RV IgA antibody concentration lower than (<) 20 U/mL, seroconversion is achieved when the post-vaccination concentration is greater than or equal to (≥) 20 U/mL and
- for subjects with a pre-vaccination anti-RV IgA antibody concentration ≥ 20 U/mL, seroconversion is achieved when the post-vaccination concentration is ≥ 2 times the pre-vaccination concentration.
Measured: At Month 2
Number of Subjects With Any Solicited General Adverse Events (AEs)
Solicited general AEs assessed were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Measured: During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)
Number of Subjects With Any Unsolicited AEs
An unsolicited AE is defined as 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, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AE. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Measured: During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization and/or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Measured: Throughout the study period (from Day 1 up to Month 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study start20 Feb 2019
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
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.
- Other trials for 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
- None (open label)
- Enrolment
- 451 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
- NCT02141204
- Sponsor's protocol ID
- 116566
- Other IDs
- 2012-001875-35
- Status last verified
- Oct 2020
- First submitted
- 15 May 2014
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of Two Different Formulations of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, Rotarix in Healthy Infants
- ClinicalTrials.gov ID
- NCT02141204
- Acronym / sponsor ID
- 116566
- Conditions
- Rotavirus
- Keywords
- Rotarix, HRV, Healthy infants, Liquid formulation, Lyophilized formulation, Human rotavirus vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Posted 9 Dec 2020
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 immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose one, with no previous history of rotavirus illness or vaccination.
While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008, this study is conducted to generate additional clinical data for the liquid formulation of the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines (NDAC-Vaccines) of Drug Controller General of India (DCGI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV Liq Group | Experimental | Biological: HRV LiquidSubjects aged 6 to 10 weeks at the time of first vaccination, who received two oral doses of Liquid Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. |
| HRV Lyo Group | Active comparator | Biological: HRV LyophilizedSubjects aged 6 to 10 weeks at the time of first vaccination who received two oral doses of Lyophilized Human Rotavirus Vaccine (HRV) according to a two-dose schedule, at Day 1 and Month 1. |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects' parent(s)/ Legally Acceptable Representative (s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any study specific procedure.
- A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Birth weight >2000 grams.
Key exclusion criteria (24 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccine (Day-29 to Day 1), or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of any chronic drug therapy to be continued during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3; with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations, according to the local immunization practice.
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 |
|---|---|---|
| HRV LiquidTwo doses administered orally according to a 0, 1-month schedule. | Biological | HRV Liq Group |
| HRV LyophilizedTwo doses administered orally according to a 0, 1-month schedule. | Biological | HRV Lyo Group |
Primary outcome
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations
Time frame: At Month 2
Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).
4 secondary outcomes
Percentage of Seroconverted Subjects for Anti-RV IgA Antibodies
Time frame: At Month 2
Number of Subjects With Any Solicited General Adverse Events (AEs)
Time frame: During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)
Number of Subjects With Any Unsolicited AEs
Time frame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: Throughout the study period (from Day 1 up to Month 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRV Liquid and HRV Lyophilized in people with Rotavirus, run by GlaxoSmithKline at 8 sites in India.
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 5 inclusion and 24 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2020). 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?
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations (time frame: At Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2020.