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Infections, RotavirusPhase 3NCT00140686

To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

A Phase 3 study testing Rotavirus (vaccine) in people with Infections, Rotavirus, run by GlaxoSmithKline at 101 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period. Read more about this study

Who is it for?
Ages 6 to 14 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Rotavirus
What is being tested?
Rotavirus (vaccine)
Type of treatment
Vaccines
How many people
3,994 participants
Where
101 sitesin 6 countries
Study dates
Sep 2004to Aug 2006
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 14 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight > 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).

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 planned use during the study period.
  • Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
  • Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.)
  • History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B disease (in all subjects). Only for subjects in Spain: history of meningococcal group C disease. Only for subjects in France and Germany: history of disease caused by Streptococcus pneumoniae.
  • History of use of experimental rotavirus vaccine.
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (in all subjects). Only for subjects in Spain: previous vaccination against meningococcal group C. Only for subjects in France and Germany: previous vaccination against Streptococcus pneumoniae.
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  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract, IS or other medical condition determined to be serious by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).)
  • Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
  • A family history of congenital or hereditary immunodeficiency.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • History of any neurologic disorders or seizures.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Trial locations and contacts

101 sites in 6 countries.

101 sites in 6 countries

Germany31 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 10967

  • GSK Investigational Site

    Berlin, State of Berlin, 12679

  • GSK Investigational Site

    Birkenfeld, Baden-Wurttemberg, 75217

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44866

  • GSK Investigational Site

    Bützow, Mecklenburg-Vorpommern, 18246

  • GSK Investigational Site

    Cossebaude, Saxony, 01462

  • GSK Investigational Site

    Detmold, North Rhine-Westphalia, 32756

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Espelkamp, North Rhine-Westphalia, 32339

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24937

  • GSK Investigational Site

    Freising, Bavaria, 85354

  • GSK Investigational Site

    Fulda, Hesse, 36037

  • GSK Investigational Site

    Glücksburg, Schleswig-Holstein, 24960

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Gütersloh, North Rhine-Westphalia, 33332

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22089

  • GSK Investigational Site

    Kaufering, Bavaria, 86916

  • GSK Investigational Site

    Leipzig, Saxony, 04317

  • GSK Investigational Site

    Löhne, North Rhine-Westphalia, 32584

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Minden, North Rhine-Westphalia, 32427

  • GSK Investigational Site

    Munich, Bavaria, 81241

  • GSK Investigational Site

    Oberhausen, North Rhine-Westphalia, 46145

  • GSK Investigational Site

    Oberkirch, Baden-Wurttemberg, 77704

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18146

  • GSK Investigational Site

    Salzgitter, Lower Saxony, 38226

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

  • GSK Investigational Site

    Wiesbaden, Hesse, 65205

  • GSK Investigational Site

    Willich, North Rhine-Westphalia, 47877

  • GSK Investigational Site

    Wolfenbüttel, Lower Saxony, 38302

Other trials in Germany

France20 sites

  • GSK Investigational Site

    Boulogne, 92100

  • GSK Investigational Site

    Châlons-en-Champagne, 51000

  • GSK Investigational Site

    Chambéry, 73000

  • GSK Investigational Site

    Courbevoie, 92400

  • GSK Investigational Site

    Draguignan, 83300

  • GSK Investigational Site

    Essey-lès-Nancy, 54270

  • GSK Investigational Site

    Floirac, 33270

  • GSK Investigational Site

    Gradignan, 33190

  • GSK Investigational Site

    Issy-les-Moulineaux, 92130

  • GSK Investigational Site

    Le Havre, 76600

  • GSK Investigational Site

    Les Lilas, 93260

  • GSK Investigational Site

    Manosque, 04100

  • GSK Investigational Site

    Maromme, 76150

  • GSK Investigational Site

    Maurepas, 78310

  • GSK Investigational Site

    Nogent-sur-Marne, 94130

  • GSK Investigational Site

    Paris, 75020

  • GSK Investigational Site

    Rosny-sous-Bois, 93100

  • GSK Investigational Site

    Rouen, 76000

  • GSK Investigational Site

    Saint-Quentin, 02100

  • GSK Investigational Site

    Thionville

Other trials in France

Finland18 sites

  • GSK Investigational Site

    Espoo, 02100

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Hyvinkää, 05800

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Jyväskylä, 40100

  • GSK Investigational Site

    Kokkola, 67100

  • GSK Investigational Site

    Kotka, 48100

  • GSK Investigational Site

    Kuopio, 70100

  • GSK Investigational Site

    Lahti, 15140

  • GSK Investigational Site

    Oulu, 90100

  • GSK Investigational Site

    Pori, 28120

  • GSK Investigational Site

    Riihimäki, 11120

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33200

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Turku, 20520

  • GSK Investigational Site

    Vantaa, 01300

  • GSK Investigational Site

    Vantaa, 01600

Other trials in Finland

Spain14 sites

  • GSK Investigational Site

    Almería, 04009

  • GSK Investigational Site

    Baracaldo (Vizcaya), 48902

  • GSK Investigational Site

    Barakaldo, 48903

  • GSK Investigational Site

    Barcelona, 08017

  • GSK Investigational Site

    Berango (Vizcaya), 48640

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Blanes

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Móstoles/Madrid, 28935

  • GSK Investigational Site

    Munguía (Vizcaya), 48100

  • GSK Investigational Site

    San Vicent Dels Horts

  • GSK Investigational Site

    Sant Adriá de Beyós, Barcelona, 08930

  • GSK Investigational Site

    Sant Eugenia de Berga, Barcelona, 08519

  • GSK Investigational Site

    Sodupe (Vizcaya), 48840

Other trials in Spain

Czechia13 sites

  • GSK Investigational Site

    Brno, 628 00

  • GSK Investigational Site

    Havlíčkův Brod, 580 22

  • GSK Investigational Site

    Hradec Králové, 500 02

  • GSK Investigational Site

    Humpolec, 396 01

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Ostrava, 728 92

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Prague, 140 00

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Prague, 160 00

  • GSK Investigational Site

    Prague, 190 00

  • GSK Investigational Site

    Znojmo, 669 00

Other trials in Czechia

Italy5 sites

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Genoa, Liguria, 16100

  • GSK Investigational Site

    Ragusa, Sicily, 97100

  • GSK Investigational Site

    Rome, Lazio, 00165

  • GSK Investigational Site

    Rome, Lazio, 00193

Other trials in Italy

About this study

Official title: A Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.

Read the detailed description

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Being tested
Rotavirus (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.

  • Rotavirus (vaccine)Biological

What is being measured

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

  1. Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.

Secondary outcomes (12)

  1. Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.

  2. Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.

  3. Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of non-G1 serotypes during each efficacy follow-up period.

  4. Occurrence of hospitalization due to RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.

  5. Occurrence of any medical attention (medical provider contact, advice, visit; emergency room contact or visit or hospitalization) for RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.

  6. Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the period starting from Dose 1 of the study vaccine until Visit 5.

  7. Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who completed the two-dose vaccination course before the RV epidemic season.

  8. Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who were vaccinated during the RV epidemic season.

  9. Immune response to HRV vaccine at Visit 1 and Visit 3.

  10. Immune response to all antigens contained in each of the different childhood vaccines at Visit 3 and Visit 4 or Visit 6 (if applicable):

  11. In a subset of subjects (N=1800), occurrence of each type of solicited symptom within the 8-day solicited follow-up period (Day 0 to Day 7) after each dose of HRV/placebo.

  12. For all subjects, occurrence of unsolicited symptoms within 31 days (Day 0 to Day 30) after each dose of HRV/placebo and SAEs throughout the entire study period.

Timeline

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

  1. First posted1 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2006
  4. Study completionAug 2006

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,994 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140686
Sponsor's protocol ID
102247/036
Status last verified
Mar 2017
First submitted
31 Aug 2005
Last updated
23 Mar 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

  • 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

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

  • Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007 Nov 24;370(9601):1757-63. doi: 10.1016/S0140-6736(07)61744-9.

    PubMed 18037080

  • Vesikari T, Prymula R, Schuster V, Tejedor JC, Cohen R, Bouckenooghe A, Damaso S, Han HH. Efficacy and immunogenicity of live-attenuated human rotavirus vaccine in breast-fed and formula-fed European infants. Pediatr Infect Dis J. 2012 May;31(5):509-13. doi: 10.1097/INF.0b013e3182489cac.

    PubMed 22228235

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rotavirus (vaccine) in people with Infections, Rotavirus, run by GlaxoSmithKline at 101 sites in 6 countries.

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 1 inclusion and 15 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in Germany, France, Finland, Spain, Czechia and 1 more country. 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?

Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy 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 NCT00140686, which also lists 4 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 23 Mar 2017.

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