Last updated: 11/06/2018 23:54:13
To test 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants in co-administration with specific childhood vaccines
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
3994
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
De Vos B et al. (2009) 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. 28(4):261-266.
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 et al. (2007) Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 370(9601): 1757-1763.
Vesikari T et al. (2012) Efficacy and immunogenicity of live-attenuated human rotavirus vaccine in breast-fed and formula-fed European infants. Pediatr Infect Dis J. 31(5):509-513.
Buyse H et al. (2014) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1):19-24.
Cheuvart B et al. (2014) Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: Analysis of clinical trials of human rotavirus vaccine. Human Vaccines & Immunotherapeutics. 10(2):505–511.
Cunliffe N et al. (2014) Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414. BMC Pediatr. 14(1):295.
Han HH et al. (2017) Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis. Hum Vaccin Immunother. 3(1):237-244.
Vesikari T et al. (2010) Immunogenicity and safety of the human rotavirus vaccine Rotarix™ co-administered with routine infant vaccines following the vaccination schedules in Europe . Vaccine. 28(32):5272-5279.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
September 2004 to August 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 14 weeks
Accepts healthy volunteers
Yes
- 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).
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22089
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Status
Study Complete
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
Status
Study Complete
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
Status
Study Complete
Location
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Sant Eugenia de Berga, Barcelona, Spain, 08519
Status
Study Complete
Location
GSK Investigational Site
Gluecksburg, Schleswig-Holstein, Germany, 24960
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Sant Adriá de Beyós, Barcelona, Spain, 08930
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Espelkamp, Nordrhein-Westfalen, Germany, 32339
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Havlickuv Brod, Czech Republic, 580 22
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18146
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
Status
Study Complete
Location
GSK Investigational Site
Birkenfeld, Baden-Wuerttemberg, Germany, 75217
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Hradec kralove, Czech Republic, 500 02
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-10-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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