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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00140686
First received: August 31, 2005
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Rotavirus Infection
Biological: Rotavirus (vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period. [ Designated as safety issue: No ]
  • Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • Occurrence of hospitalization due to RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • Immune response to HRV vaccine at Visit 1 and Visit 3. [ Designated as safety issue: No ]
  • Immune response to all antigens contained in each of the different childhood vaccines at Visit 3 and Visit 4 or Visit 6 (if applicable): [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]

Enrollment: 3994
Study Start Date: September 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 14 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140686

  Show 88 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Vesikari T et al. Human rotavirus vaccine rotarix ™ is highly efficacious in Europe during the first two years of life. Abstract presented at the 25th meeting of European society for Paediatric Infectious Diseases (ESPID), Porto, Portugal, 2-4-May-2007.
Tejedor JC et al. Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic when co-administered with a neisseria meningitides serogroup C vaccine (Meningitec™) in healthy infants from Spain. Abstract presented at the 24th meeting of European society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006.
Soriano-Gabarró M et al. Potential impact of RotarixTM according to rotavirus serotype distribution. Abstract presented at the 4th World Congress of the World Society of Pediatric Infectious Diseases, Warsaw, Poland, 1-4 September 2005.
Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00140686     History of Changes
Other Study ID Numbers: 102247/036
Study First Received: August 31, 2005
Last Updated: August 18, 2011
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014