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

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140686
• Other study ID #: 102247/036
• 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
• 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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

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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