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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00140686
Other study ID # 102247/036
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated March 21, 2017
Start date September 2004
Est. completion date August 2006

Study information

Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 3994
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Weeks to 14 Weeks
Eligibility Inclusion criteria:

- 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).

Exclusion criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Rotavirus (vaccine)


Locations

Country Name City State
Czech Republic GSK Investigational Site Brno
Czech Republic GSK Investigational Site Havlickuv Brod
Czech Republic GSK Investigational Site Hradec kralove
Czech Republic GSK Investigational Site Humpolec
Czech Republic GSK Investigational Site Jindrichuv Hradec
Czech Republic GSK Investigational Site Nachod
Czech Republic GSK Investigational Site Ostrava
Czech Republic GSK Investigational Site Pardubice
Czech Republic GSK Investigational Site Praha 4
Czech Republic GSK Investigational Site Praha 5
Czech Republic GSK Investigational Site Praha 6
Czech Republic GSK Investigational Site Praha 9
Czech Republic GSK Investigational Site Znojmo
Finland GSK Investigational Site Espoo
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Hyvinkaa
Finland GSK Investigational Site Jarvenpaa
Finland GSK Investigational Site Jyvaskyla
Finland GSK Investigational Site Kokkola
Finland GSK Investigational Site Kotka
Finland GSK Investigational Site Kuopio
Finland GSK Investigational Site Lahti
Finland GSK Investigational Site Oulu
Finland GSK Investigational Site Pori
Finland GSK Investigational Site Riihimaki
Finland GSK Investigational Site Seinajoki
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Turku
Finland GSK Investigational Site Vantaa
Finland GSK Investigational Site Vantaa
France GSK Investigational Site Boulogne
France GSK Investigational Site Chalons en Champagne
France GSK Investigational Site Chambéry
France GSK Investigational Site Courbevoie
France GSK Investigational Site Draguignan
France GSK Investigational Site Essey les Nancy
France GSK Investigational Site Floirac
France GSK Investigational Site Gradignan
France GSK Investigational Site Issy les Moulineaux
France GSK Investigational Site Le Havre
France GSK Investigational Site Les Lilas
France GSK Investigational Site Manosque
France GSK Investigational Site Maromme
France GSK Investigational Site Maurepas
France GSK Investigational Site Nogent Sur Marne
France GSK Investigational Site Nogent-sur-Marne
France GSK Investigational Site Paris
France GSK Investigational Site Rosny Sous Bois
France GSK Investigational Site Rouen
France GSK Investigational Site Saint Quentin
France GSK Investigational Site Thionville
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Birkenfeld Baden-Wuerttemberg
Germany GSK Investigational Site Bochum Nordrhein-Westfalen
Germany GSK Investigational Site Buetzow Mecklenburg-Vorpommern
Germany GSK Investigational Site Cossebaude Sachsen
Germany GSK Investigational Site Detmold Nordrhein-Westfalen
Germany GSK Investigational Site Eschwege Hessen
Germany GSK Investigational Site Espelkamp Nordrhein-Westfalen
Germany GSK Investigational Site Flensburg Schleswig-Holstein
Germany GSK Investigational Site Freising Bayern
Germany GSK Investigational Site Fulda Hessen
Germany GSK Investigational Site Gluecksburg Schleswig-Holstein
Germany GSK Investigational Site Goch Nordrhein-Westfalen
Germany GSK Investigational Site Guetersloh Nordrhein-Westfalen
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Kaufering Bayern
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Loehne Nordrhein-Westfalen
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Germany GSK Investigational Site Minden Nordrhein-Westfalen
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Oberhausen Nordrhein-Westfalen
Germany GSK Investigational Site Oberkirch Baden-Wuerttemberg
Germany GSK Investigational Site Rostock Mecklenburg-Vorpommern
Germany GSK Investigational Site Salzgitter Niedersachsen
Germany GSK Investigational Site Trier Rheinland-Pfalz
Germany GSK Investigational Site Velbert Nordrhein-Westfalen
Germany GSK Investigational Site Wiesbaden Hessen
Germany GSK Investigational Site Willich Nordrhein-Westfalen
Germany GSK Investigational Site Wolfenbuettel Niedersachsen
Italy GSK Investigational Site Bari Puglia
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Ragusa Sicilia
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Roma Lazio
Spain GSK Investigational Site Almería
Spain GSK Investigational Site Baracaldo
Spain GSK Investigational Site Baracaldo (Vizcaya)
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Berango (Vizcaya)
Spain GSK Investigational Site Bilbao
Spain GSK Investigational Site Blanes
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Móstoles/Madrid
Spain GSK Investigational Site Munguía (Vizcaya)
Spain GSK Investigational Site San Vicent dels Horts
Spain GSK Investigational Site Sant Adriá de Beyós, Barcelona
Spain GSK Investigational Site Sant Eugenia de Berga, Barcelona
Spain GSK Investigational Site Sodupe (Vizcaya)

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Czech Republic,  Finland,  France,  Germany,  Italy,  Spain, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
Secondary Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.
Secondary Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.
Secondary 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.
Secondary Occurrence of hospitalization due to RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Immune response to HRV vaccine at Visit 1 and Visit 3.
Secondary Immune response to all antigens contained in each of the different childhood vaccines at Visit 3 and Visit 4 or Visit 6 (if applicable):
Secondary 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.
Secondary 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.
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