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Infections, RotavirusPhase 2NCT00432380

A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

A Phase 2 study testing Rotarix™ in people with Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 1 site in Philippines.

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

This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines. Read more about this study

Who is it for?
Ages 5 to 10 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Rotavirus, Rotavirus Vaccines
What is being tested?
Rotarix™
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
375 participants
Where
1 sitePhilippines
Study dates
9 Mar 2007to 4 Sep 2007
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 5 to 10 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
  • Birth weight of the subject should be > 2000 grams.
  • Written informed consent obtained from the parent or guardian of the subject.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI.
  • Concurrently participating in another clinical study, at any time during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • GSK Investigational Site

    City of Muntinlupa

Other trials in Philippines

About this study

Official title: Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.

This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.

Being tested
Rotarix™, Placebo
Keywords
Placebo, Double blind, Gastroenteritis, Randomized, Oral live attenuated human rotavirus liquid 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.

  • Rotarix™Biological

    oral doses

  • PlaceboBiological

    oral dose

Study groups in NCT00432380
Study groupRoleWhat they receive
PLACEBO-ROTARIX-ROTARIX GROUPExperimentalHealthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Receives: Biological: Rotarix™; Biological: Placebo
ROTARIX-PLACEBO-ROTARIX GROUPExperimentalHealthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Receives: Biological: Rotarix™; Biological: Placebo
PLACEBO GROUPPlacebo comparatorHealthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Receives: Biological: Placebo

What is being measured

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

  1. Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody

    Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.

    Measured: At Month 3

Secondary outcomes (7)

  1. Number of Seroconverted Subjects for Anti-RV IgA Antibody

    Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.

    Measured: At Month 3

  2. Serum IgA Antibody Concentrations Against Rotavirus

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.

    Measured: At Month 3

  3. Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea

    Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.

    Measured: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

  4. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

    Measured: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

  5. Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes

    Presence of RV (vaccine strain or wild-type) in GE stools.

    Measured: From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3

  6. Number of Subjects Reporting Any Unsolicited Adverse Event (AE)

    An unsolicited AE covers 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

    Measured: During the 31-day (Days 0-30) period following any study vaccine dose or placebo

  7. Number of Subjects With Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.

    Measured: During the entire study period (from Day 0 to Month 3)

Timeline

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

  1. First posted7 Feb 2007 (estimated)
  2. Study start9 Mar 2007
  3. Primary completion4 Sep 2007
  4. Study completion4 Sep 2007

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00432380
Sponsor's protocol ID
109216
Other IDs
2015-001544-11, 2015
Status last verified
Dec 2019
First submitted
6 Feb 2007
Last updated
2 Jan 2020
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21.

    PubMed 21256876

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rotarix™ in people with Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 1 site in Philippines.

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 8 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 2 Jan 2020. 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 Philippines. 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 11 Sep 2017). 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 Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody (time frame: At Month 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 NCT00432380, 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 2 Jan 2020.

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