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Infections, RotavirusPhase 2NCT00385320

Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

A Phase 2 study testing HRV vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline.

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

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine. Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Rotavirus
What is being tested?
HRV vaccine
Type of treatment
Vaccines
How many people
2,640 participants
Where
No sites listed yet
Study dates
31 May 2001to 30 Apr 2003
Phase
Phase 2
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

  • Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
  • Written informed consent obtained from the parent or guardian of the subject.

Who cannot join

  • Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
  • Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
  • History of allergic disease
  • 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.
Show all 10Show fewer
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
  • Previous confirmed occurrence of RV GE.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period

About this study

Official title: To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.

Being tested
HRV vaccine
Medical subject headings
Rotavirus Infections

What participants receive

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

  • HRV vaccineBiological

What is being measured

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

  1. Occurrence of RV GE

Secondary outcomes (1)

  1. Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE

Timeline

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

  1. First posted9 Oct 2006 (estimated)
  2. Study start31 May 2001
  3. Primary completion30 Apr 2003
  4. Study completion30 Apr 2003

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
Enrolment
2,640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00385320
Sponsor's protocol ID
444563/006
Status last verified
Dec 2019
First submitted
6 Oct 2006
Last updated
27 Dec 2019
Results posted
No
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Araujo EC, Clemens SA, Oliveira CS, Justino MC, Rubio P, Gabbay YB, da Silva VB, Mascarenhas JD, Noronha VL, Clemens R, Gusmao RH, Sanchez N, Monteiro TA, Linhares AC. Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy infants. J Pediatr (Rio J). 2007 May-Jun;83(3):217-24. doi: 10.2223/JPED.1600. Epub 2007 Mar 20.

    PubMed 17380232

  • 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 24047799

  • Cheuvart B, Neuzil KM, Steele AD, Cunliffe N, Madhi SA, Karkada N, Han HH, Vinals C. Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine. Hum Vaccin Immunother. 2014;10(2):505-11. doi: 10.4161/hv.27097. Epub 2013 Nov 13.

    PubMed 24240068

  • De Vos B, Vesikari T, Linhares AC, Salinas B, Perez-Schael I, Ruiz-Palacios GM, Guerrero Mde L, Phua KB, Delem A, Hardt K. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 2004 Oct;23(10 Suppl):S179-82. doi: 10.1097/01.inf.0000142370.16514.4a.

    PubMed 15502699

  • De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.

    PubMed 19289978

  • Linhares AC, Ruiz-Palacios GM, Guerrero ML, Salinas B, Perez-Schael I, Clemens SA, Innis B, Yarzabal JP, Vespa G, Cervantes Y, Hardt K, De Vos B. A short report on highlights of world-wide development of RIX4414: a Latin American experience. Vaccine. 2006 May 1;24(18):3784-5. doi: 10.1016/j.vaccine.2005.07.027. Epub 2005 Jul 26.

    PubMed 16098636

  • Linhares AC, Verstraeten T, Wolleswinkel-van den Bosch J, Clemens R, Breuer T. Rotavirus serotype G9 is associated with more-severe disease in Latin America. Clin Infect Dis. 2006 Aug 1;43(3):312-4. doi: 10.1086/505493. Epub 2006 Jun 23.

    PubMed 16804845

  • Perez-Schael I, Salinas B, Tomat M, Linhares AC, Guerrero ML, Ruiz-Palacios GM, Bouckenooghe A, Yarzabal JP. Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J Infect Dis. 2007 Aug 15;196(4):537-40. doi: 10.1086/519687. Epub 2007 Jun 29.

    PubMed 17624838

  • Ruiz-Palacios GM, Guerrero ML, Bautista-Marquez A, Ortega-Gallegos H, Tuz-Dzib F, Reyes-Gonzalez L, Rosales-Pedraza G, Martinez-Lopez J, Castanon-Acosta E, Cervantes Y, Costa-Clemens S, DeVos B. Dose response and efficacy of a live, attenuated human rotavirus vaccine in Mexican infants. Pediatrics. 2007 Aug;120(2):e253-61. doi: 10.1542/peds.2006-2630. Epub 2007 Jul 2.

    PubMed 17606534

  • Salinas B, Perez Schael I, Linhares AC, Ruiz Palacios GM, Guerrero ML, Yarzabal JP, Cervantes Y, Costa Clemens S, Damaso S, Hardt K, De Vos B. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J. 2005 Sep;24(9):807-16. doi: 10.1097/01.inf.0000178294.13954.a1.

    PubMed 16148848

  • Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRV vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline.

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 2 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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 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?

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?

Occurrence of RV GE. 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 NCT00385320, which also lists 11 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 27 Dec 2019.

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