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AzTrials

Rotavirus GastroenteritisPhase 3NCT00169455

Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants

A Phase 3 study testing Live attenuated human rotavirus vaccine in people with Rotavirus Gastroenteritis, run by GlaxoSmithKline at 2 sites in Thailand.

Completed

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

Official record
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Trial summary

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Rotavirus Gastroenteritis
What is being tested?
Live attenuated human rotavirus vaccine
Type of treatment
Vaccines
How many people
450 participants
Where
2 sitesThailand
Study dates
Mar 2005to Dec 2005
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

  • A male or female between, and including, 6 and 12 weeks (42-90 days) 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 placebo, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose, since birth. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • Planned administration of a vaccine (except routine paediatric vaccines) not foreseen by the study protocol. (If exceptionally OPV is given, this should be administered at least 14 days apart from the HRV vaccine or placebo dose.)
  • 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 reactions likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
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  • Major congenital defects or serious chronic illness.
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via e.g. breastfeeding is allowed.
  • Previous confirmed occurrence of RV gastroenteritis.

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: A Phase IIIb, Partially Blind, Randomized, Placebo-controlled Study to Asses the Effect on Immunogenicity of Administration of Vaccine Without Buffering Agent and to Assess Heat Stability in Terms of Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Following a 0, 2 Month Schedule, in Healthy Infants Previously Uninfected With Human Rotavirus

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.

Read the detailed description

Assess the effect on immunogenicity of administration of vaccine without buffering agent \& assess heat stability in terms of immunogenicity, reactogenicity \& safety of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine following a 0,2 m schedule, in healthy infants previously uninfected with human rotavirus

Being tested
Live attenuated human rotavirus vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Live attenuated human rotavirus vaccineBiological

What is being measured

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

  1. Percentage of subjects with vaccine take

    Measured: At 2 months post-Dose 2

Secondary outcomes (8)

  1. Percentage of subjects who seroconverted (percentage of subjects with concentrations ≥ 20 U/mL in subjects who were negative for rotavirus (RV) before vaccination)

    Measured: At 2 months post-Dose 2

  2. Evaluation of the serum anti-RV IgA (immunoglobulin A) antibody concentrations expressed as Geometric Mean Concentrations (GMC)

    Measured: At 2 months post-Dose 2

  3. Rotavirus antigen shedding in planned stool samples

    Measured: At Day 0, Day 7 and Day 15 post each study vaccine dose

  4. Presence of RV in gastroenteritis (GE) episode stools collected

    Measured: From Dose 1 of HRV vaccine/placebo up to 2 months post-Dose 2

  5. For each type of solicited symptoms, occurrence of the symptom

    Measured: Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose

  6. Occurrence of any Grade 2 or Grade 3 fever, vomiting or diarrhea

    Measured: Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose

  7. Occurrence of unsolicited adverse events (AEs) according to Medical Dictionary for Regulatory Activities (MedDRA) classification

    Measured: Within 31 days (Day 0-30) after each study vaccine dose

  8. Occurrence of serious adverse events (SAEs) according to MedDRA classification

    Measured: Throughout the study period (Day 0 to Month 4)

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

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
Single blind
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169455
Sponsor's protocol ID
103477
Status last verified
Jan 2017
First submitted
9 Sep 2005
Last updated
16 Jan 2017
Results posted
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

  • Chokephaibulkit K et al. Immunogenicity And Vaccine Take Of RIX4414 (Rotarix") After Heat Exposure. Abstract presented at the 5th World Congress of the World Society for Pediatric infectious Diseases (WSPID). Bangkok, Thailand, 15-18 November 2007.

  • Debrus S et al. Study of the viral activity of RIX4414 - human rotavirus vaccine. Abstract presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, USA, 17-20 September 2007.

  • Debrus S et al. Viral shedding (methodology). Abstract presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, USA, 17-20 September 2007.

  • Kerdpanich A, Chokephaibulkit K, Watanaveeradej V, Vanprapar N, Simasathien S, Phavichitr N, Bock HL, Damaso S, Hutagalung Y, Han HH. Immunogenicity of a live-attenuated human rotavirus RIX4414 vaccine with or without buffering agent. Hum Vaccin. 2010 Mar 26;6(3):10428. doi: 10.4161/hv.6.3.10428. Epub 2010 Mar 26.

    PubMed 20220306

  • Kerdpanich A et al. Feeding does not influence the immunogenicity of RIX4414 (Rotarix") in Thailand. Abstract presented at the 5th World Congress of the World Society for Pediatric infectious Diseases ( WSPID). Bangkok, Thailand, 15-18 November 2007.

  • Kerdpanich et al. Exposure to elevated temperature of 37°C for 7 days does not affect immunogenicity and reactogenicity of RIX4414. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 October 2006.

  • Kerdpanich A, Chokephaibulkit K, Watanaveeradej V, Vanprapar N, Simasathien S, Phavichitr N, Bock HL, Damaso S, Hutagalung Y, Han HH. Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37 degrees C for seven days. Hum Vaccin. 2011 Jan 1;7(1):74-80. doi: 10.4161/hv.7.1.13412. Epub 2011 Jan 1.

    PubMed 21228629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Live attenuated human rotavirus vaccine in people with Rotavirus Gastroenteritis, run by GlaxoSmithKline at 2 sites in Thailand.

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 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. 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?

Percentage of subjects with vaccine take (time frame: At 2 months post-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 NCT00169455, which also lists 7 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 16 Jan 2017.

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