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

NCT00140686 | Completed Phase 3

• 1 other identifier: 102247/036
• Study Type: interventional
• Target: 3,994
• Locations: 6 countries
• Sites: 101

Brief Summary

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

Conditions

Infections, Rotavirus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

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

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

• 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.

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

• 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.

Interventions

Rotavirus (vaccine) BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 14 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (101)

GSK Investigational Site

Brno, 628 00, Czechia

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GSK Investigational Site

Havlíčkův Brod, 580 22, Czechia

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GSK Investigational Site

Hradec Králové, 500 02, Czechia

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GSK Investigational Site

Humpolec, 396 01, Czechia

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GSK Investigational Site

Jindřichův Hradec, 377 01, Czechia

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GSK Investigational Site

Náchod, 547 01, Czechia

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GSK Investigational Site

Ostrava, 728 92, Czechia

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GSK Investigational Site

Pardubice, 532 03, Czechia

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GSK Investigational Site

Prague, 140 00, Czechia

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Prague, 150 06, Czechia

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Prague, 160 00, Czechia

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Prague, 190 00, Czechia

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GSK Investigational Site

Znojmo, 669 00, Czechia

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GSK Investigational Site

Espoo, 02100, Finland

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GSK Investigational Site

Helsinki, 00100, Finland

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GSK Investigational Site

Hyvinkää, 05800, Finland

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GSK Investigational Site

Jarvenpaa, 04400, Finland

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GSK Investigational Site

Jyväskylä, 40100, Finland

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GSK Investigational Site

Kokkola, 67100, Finland

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Kotka, 48100, Finland

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GSK Investigational Site

Kuopio, 70100, Finland

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Lahti, 15140, Finland

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Oulu, 90100, Finland

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GSK Investigational Site

Pori, 28120, Finland

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GSK Investigational Site

Riihimäki, 11120, Finland

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GSK Investigational Site

Seinäjoki, 60100, Finland

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GSK Investigational Site

Tampere, 33200, Finland

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GSK Investigational Site

Tampere, 33520, Finland

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GSK Investigational Site

Turku, 20520, Finland

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Vantaa, 01300, Finland

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GSK Investigational Site

Vantaa, 01600, Finland

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GSK Investigational Site

Boulogne, 92100, France

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GSK Investigational Site

Chambéry, 73000, France

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Châlons-en-Champagne, 51000, France

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Courbevoie, 92400, France

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GSK Investigational Site

Draguignan, 83300, France

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GSK Investigational Site

Essey-lès-Nancy, 54270, France

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GSK Investigational Site

Floirac, 33270, France

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Gradignan, 33190, France

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GSK Investigational Site

Issy-les-Moulineaux, 92130, France

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GSK Investigational Site

Le Havre, 76600, France

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GSK Investigational Site

Les Lilas, 93260, France

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GSK Investigational Site

Manosque, 04100, France

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GSK Investigational Site

Maromme, 76150, France

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GSK Investigational Site

Maurepas, 78310, France

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GSK Investigational Site

Nogent-sur-Marne, 94130, France

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GSK Investigational Site

Paris, 75020, France

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GSK Investigational Site

Rosny-sous-Bois, 93100, France

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GSK Investigational Site

Rouen, 76000, France

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GSK Investigational Site

Saint-Quentin, 02100, France

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GSK Investigational Site

Thionville, France

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GSK Investigational Site

Birkenfeld, Baden-Wurttemberg, 75217, Germany

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

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GSK Investigational Site

Oberkirch, Baden-Wurttemberg, 77704, Germany

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GSK Investigational Site

Freising, Bavaria, 85354, Germany

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GSK Investigational Site

Kaufering, Bavaria, 86916, Germany

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GSK Investigational Site

Munich, Bavaria, 81241, Germany

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GSK Investigational Site

Hamburg, Hamburg, 22089, Germany

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GSK Investigational Site

Eschwege, Hesse, 37269, Germany

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GSK Investigational Site

Fulda, Hesse, 36037, Germany

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GSK Investigational Site

Wiesbaden, Hesse, 65205, Germany

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GSK Investigational Site

Salzgitter, Lower Saxony, 38226, Germany

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GSK Investigational Site

Wolfenbüttel, Lower Saxony, 38302, Germany

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Bützow, Mecklenburg-Vorpommern, 18246, Germany

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Rostock, Mecklenburg-Vorpommern, 18146, Germany

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Bochum, North Rhine-Westphalia, 44866, Germany

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Detmold, North Rhine-Westphalia, 32756, Germany

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Espelkamp, North Rhine-Westphalia, 32339, Germany

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Goch, North Rhine-Westphalia, 47574, Germany

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Gütersloh, North Rhine-Westphalia, 33332, Germany

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Löhne, North Rhine-Westphalia, 32584, Germany

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Minden, North Rhine-Westphalia, 32427, Germany

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GSK Investigational Site

Oberhausen, North Rhine-Westphalia, 46145, Germany

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Velbert, North Rhine-Westphalia, 42551, Germany

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GSK Investigational Site

Willich, North Rhine-Westphalia, 47877, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

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Cossebaude, Saxony, 01462, Germany

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Leipzig, Saxony, 04317, Germany

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GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

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Glücksburg, Schleswig-Holstein, 24960, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10967, Germany

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GSK Investigational Site

Berlin, State of Berlin, 12679, Germany

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Bari, Apulia, 70124, Italy

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GSK Investigational Site

Rome, Lazio, 00165, Italy

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Rome, Lazio, 00193, Italy

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GSK Investigational Site

Genoa, Liguria, 16100, Italy

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Ragusa, Sicily, 97100, Italy

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GSK Investigational Site

Almería, 04009, Spain

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GSK Investigational Site

Baracaldo (Vizcaya), 48902, Spain

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GSK Investigational Site

Barakaldo, 48903, Spain

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GSK Investigational Site

Barcelona, 08017, Spain

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GSK Investigational Site

Berango (Vizcaya), 48640, Spain

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GSK Investigational Site

Bilbao, 48013, Spain

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GSK Investigational Site

Blanes, Spain

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GSK Investigational Site

Madrid, 28047, Spain

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GSK Investigational Site

Móstoles/Madrid, 28935, Spain

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GSK Investigational Site

Munguía (Vizcaya), 48100, Spain

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GSK Investigational Site

San Vicent Dels Horts, Spain

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GSK Investigational Site

Sant Adriá de Beyós, Barcelona, 08930, Spain

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GSK Investigational Site

Sant Eugenia de Berga, Barcelona, 08519, Spain

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GSK Investigational Site

Sodupe (Vizcaya), 48840, Spain

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Related Publications (4)

• 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.

  PMID: 19289978 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18037080 BACKGROUND

• 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.

  PMID: 22228235 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: September 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (20); FI (18); ES (14); CZ (13); DE (31); IT (5)