Infections, RotavirusNCT00779779

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 1 site in Sri Lanka.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose). Read more about this study

Who is it for?: Ages 6 to 19 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
How many people: 522 participants
Where: 1 siteSri Lanka
Study dates: 22 Nov 2008to 26 Aug 2009
Phase: Observational
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 19 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 .
A male or female at least 6 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.

Who cannot join

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Any contraindication as stated in the updated and approved Prescribing Information

Trial locations and contacts

1 site in 1 country.

Sri Lanka1 site

GSK Investigational Site
Colombo, 03

Other trials in Sri Lanka

About this study

Official title: Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.

Conditions: Infections, Rotavirus
Being tested: Rotarix™
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.

Rotarix™Biological
Two oral doses, with at least 4 weeks interval in-between

Study groups in NCT00779779
Study group	Role	What they receive
Rotarix Group		Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age. Receives: Biological: Rotarix™

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea
Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.
Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.
Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.
Measured: During the 8-day solicited follow-up period

Secondary outcomes (3)

Number of Subjects Reporting Each Type of Solicited General Symptoms
Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
Measured: During the 8-day follow-up period
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day follow-up period
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Measured: Throughout the study period (Day 0 to Month 3 or 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 200826 Aug 2009

First posted24 Oct 2008 (estimated)
Study start22 Nov 2008
Primary completion25 May 2009
Study completion26 Aug 2009

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 (2)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: Observational
Enrolment: 522 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00779779
Sponsor's protocol ID: 111664
Status last verified: Feb 2011
First submitted: 23 Oct 2008
Last updated: 28 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.
Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.
PubMed 25424932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infections, Rotavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
ClinicalTrials.gov ID: NCT00779779
Acronym / sponsor ID: 111664
Conditions: Infections, Rotavirus
Keywords: Gastroenteritis
Study type: Observational
Recruitment status: Completed
Enrolment: 522 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 Nov 2008
Primary completion: 25 May 2009 (actual)
Study completion: 26 Aug 2009 (actual)
First posted: 24 Oct 2008 (estimated)
Results: Posted 30 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Number of arms: 1

Arm	Type	Receives
Rotarix Group	–	Biological: Rotarix™Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.

Who may qualify

Ages: 6 to 19 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
A male or female at least 6 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.

Key exclusion criteria (4 listed)

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Any contraindication as stated in the updated and approved Prescribing Information

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
Rotarix™Two oral doses, with at least 4 weeks interval in-between	Biological	Rotarix Group

Primary outcome

Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea
Time frame: During the 8-day solicited follow-up period
Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

3 secondary outcomes

Number of Subjects Reporting Each Type of Solicited General Symptoms
Time frame: During the 8-day follow-up period
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: During the 31-day follow-up period
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Throughout the study period (Day 0 to Month 3 or 4)

Results and safety

Results posted to the registry on 30 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rotarix Group	522	498

Primary outcome: Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea

Time frame: During the 8-day solicited follow-up period. Number. Unit: subjects

Measure	Rotarix Group n = 522
Value	78

Population analysed: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4.6% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotarix Group	1 of 522 (0.2%)	247 of 522 (47.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundRuberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.
Derived from this study: PubMed 25424932Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 1 site in Sri Lanka.

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 3 inclusion and 4 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 28 Aug 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 Sri Lanka. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2010). 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 With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea (time frame: During the 8-day solicited follow-up period). 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 NCT00779779, which also lists 2 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 28 Aug 2018.