Back to resultsTo Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Primary Purpose
Infections, Rotavirus
Status
Completed
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Lyophilized formulation of HRV vaccine
Liquid formulation of HRV vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Rotavirus focused on measuring Prophylaxis against gastroenteritis caused by Rotavirus
Eligibility Criteria
Inclusion Criteria: Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks. Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Household contact with an immunosuppressed individual or pregnant women. Previous confirmed occurrence of RV GE.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Liquid Rotarix Group
Lyophilized Rotarix Group
Arm Description
Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Outcomes
Primary Outcome Measures
Number of Seroconverted Subjects Against Human Rotavirus
A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.
Secondary Outcome Measures
Concentrations of Anti-rotavirus IgA Antibodies
Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies
Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were cough/runny nose, diarrhea, fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes
The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00363545
Brief Title
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Official Title
A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2006 (Actual)
Primary Completion Date
April 12, 2007 (Actual)
Study Completion Date
April 12, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus
Keywords
Prophylaxis against gastroenteritis caused by Rotavirus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liquid Rotarix Group
Arm Type
Experimental
Arm Description
Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Arm Title
Lyophilized Rotarix Group
Arm Type
Experimental
Arm Description
Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Intervention Type
Biological
Intervention Name(s)
Lyophilized formulation of HRV vaccine
Intervention Description
Lyophilized formulation of HRV vaccine
Intervention Type
Biological
Intervention Name(s)
Liquid formulation of HRV vaccine
Intervention Description
Liquid formulation of HRV vaccine
Primary Outcome Measure Information:
Title
Number of Seroconverted Subjects Against Human Rotavirus
Description
A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.
Time Frame
At 1 to 2 months after the second vaccine dose (Months 3-4)
Secondary Outcome Measure Information:
Title
Concentrations of Anti-rotavirus IgA Antibodies
Description
Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
Time Frame
At 1 to 2 months after the second vaccine dose (Months 3-4)
Title
Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies
Description
Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.
Time Frame
At 1 to 2 months after the second vaccine dose (Months 3-4)
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were cough/runny nose, diarrhea, fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
Throughout the entire study period (from Day 0 to Month 4)
Title
Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes
Description
The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.
Time Frame
From the first vaccine dose (Dose 1) up to Month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria:
se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Household contact with an immunosuppressed individual or pregnant women.
Previous confirmed occurrence of RV GE.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
David
Country
Panama
Facility Name
GSK Investigational Site
City
La Chorrera
Country
Panama
Facility Name
GSK Investigational Site
City
Panama
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
Citation
Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
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