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Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00729001
First received: August 4, 2008
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Condition Intervention Phase
Infections, Rotavirus
Biological: Human Rotavirus Vaccine - two different formulations
Biological: Prevnar
Biological: IPOL
Biological: Infanrix
Biological: OmniHIB
Biological: Pentacel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of subjects with vaccine take [ Time Frame: Two months after the second dose ]
  • Occurrence of any grade 2 or 3 fever, vomiting or diarrhea [ Time Frame: Within the 15-day solicited follow-up period after any dose of study vaccine. ]

Secondary Outcome Measures:
  • Occurrence of each type of solicited symptoms [ Time Frame: Within the 15-day solicited follow-up period after any dose of study vaccine ]
  • Occurrence of unsolicited symptoms according to WHO classification. [ Time Frame: Within 42 days after dose 1 and dose 2 ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study period ]
  • Serum rotavirus immunoglobulin A (IgA) antibody titers [ Time Frame: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset ]
  • Rotavirus seropositivity status [ Time Frame: Before dose 1 and at the end of the study ]
  • Vaccine take (for pilot efficacy subset only) [ Time Frame: 2 months after dose 1 ]
  • Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations [ Time Frame: Two months after dose 2 and at the end of the study. ]
  • Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F [ Time Frame: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects) ]
  • Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status. [ Time Frame: Two months after dose 2 and at the end of the study. ]
  • Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status. [ Time Frame: Two months after dose 2 and at the end of the study. ]
  • Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants [ Time Frame: Two months after dose 2. ]
  • Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects) [ Time Frame: Two weeks after dose 2 until the end of the rotavirus season following vaccination. ]

Enrollment: 529
Study Start Date: November 2000
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Human Rotavirus Vaccine - Formulation 1
Biological: Human Rotavirus Vaccine - two different formulations
Two oral doses
Biological: Prevnar
Three-dose intramuscular injection (US subjects only)
Biological: IPOL
Two-dose intramuscular injection (US subjects only)
Biological: Infanrix
Three-dose intramuscular injection (US subjects only)
Biological: OmniHIB
Three-dose intramuscular injection (US subjects only)
Other Name: ActHIB
Biological: Pentacel
Three-dose intramuscular injection (Canada only)
Experimental: Group B
Human Rotavirus Vaccine - Formulation 2
Biological: Human Rotavirus Vaccine - two different formulations
Two oral doses
Biological: Prevnar
Three-dose intramuscular injection (US subjects only)
Biological: IPOL
Two-dose intramuscular injection (US subjects only)
Biological: Infanrix
Three-dose intramuscular injection (US subjects only)
Biological: OmniHIB
Three-dose intramuscular injection (US subjects only)
Other Name: ActHIB
Biological: Pentacel
Three-dose intramuscular injection (Canada only)
Placebo Comparator: Group C Biological: Prevnar
Three-dose intramuscular injection (US subjects only)
Biological: IPOL
Two-dose intramuscular injection (US subjects only)
Biological: Infanrix
Three-dose intramuscular injection (US subjects only)
Biological: OmniHIB
Three-dose intramuscular injection (US subjects only)
Other Name: ActHIB
Biological: Pentacel
Three-dose intramuscular injection (Canada only)

Detailed Description:

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).

The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.

Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
  • Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
  • Use of antibiotics within 7 days preceding dose 1.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrollment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
  • Inability to contact parents/guardians of the subject by telephone.
  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: NCT00729001

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

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 444563/005
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 444563/005
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 444563/005
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 444563/005
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 444563/005
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 444563/005
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00729001     History of Changes
Other Study ID Numbers: 444563/005 
Study First Received: August 4, 2008
Last Updated: September 15, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Rotavirus Gastroenteritis
Human rotavirus vaccine

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016