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Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

Primary Purpose

Infections, Rotavirus

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Live attenuated rotavirus vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Prophylaxis of rotavirus gastroenteritis

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination. Written informed consent obtained from the parents or guardians of the subjects. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after a gestation period of 36 to 42 weeks inclusive. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) 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) Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition, as determined by the investigator. History of allergic diseases or reactions likely to be exacerbated by any component of the vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). Major congenital defects or serious chronic illnesses. Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever, i.e. temperature >= 37.5°C as measured by an axillary thermometer or >= 38.0°C as measured by a rectal thermometer.) Temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. Gastroenteritis (GE) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). Household contact with an immunosuppressed individual or pregnant woman. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Previous confirmed occurrence of RV GE. History of neurological disorders or seizures.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Endpoint: immunogenicity and reactogenicity
Proportion of subjects with vaccine take

Secondary Outcome Measures

Proportion of seroconverters
RV-IgA concentration
Occurrence of solicited symptoms: loss of appetite, fussiness/irritability, fever, diarrhea, vomiting, cough/runny nose
Unsolicited symptoms and serious adverse events (SAEs)

Full Information

First Posted
August 29, 2005
Last Updated
September 20, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00137930
Brief Title
Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Official Title
Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (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
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.
Detailed Description
The study consists of four groups of children recruited in different centers in Finland. One group of children will receive the existing formulation of HRV vaccine and one group will receive the new formulation of the HRV vaccine. The other two groups will receive the placebo for existing formulation or the new formulation based on the allocation. The vaccine or placebo will be administered starting at 6 - 12 weeks of age according to 0, 1 month schedule. Routine childhood vaccinations are allowed according to local practice, but at least 14 days apart from each dose of study vaccine. The duration of the study will be approximately 2 months per child.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus
Keywords
Prophylaxis of rotavirus gastroenteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Live attenuated rotavirus vaccine
Primary Outcome Measure Information:
Title
Endpoint: immunogenicity and reactogenicity
Title
Proportion of subjects with vaccine take
Secondary Outcome Measure Information:
Title
Proportion of seroconverters
Title
RV-IgA concentration
Title
Occurrence of solicited symptoms: loss of appetite, fussiness/irritability, fever, diarrhea, vomiting, cough/runny nose
Title
Unsolicited symptoms and serious adverse events (SAEs)

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: Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination. Written informed consent obtained from the parents or guardians of the subjects. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after a gestation period of 36 to 42 weeks inclusive. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) 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) Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition, as determined by the investigator. History of allergic diseases or reactions likely to be exacerbated by any component of the vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). Major congenital defects or serious chronic illnesses. Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever, i.e. temperature >= 37.5°C as measured by an axillary thermometer or >= 38.0°C as measured by a rectal thermometer.) Temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. Gastroenteritis (GE) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). Household contact with an immunosuppressed individual or pregnant woman. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Previous confirmed occurrence of RV GE. History of neurological disorders or seizures.
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
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28120
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland

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
Debrus S et al. Study of the viral activity of RIX4414 - human rotavirus vaccine. Abstract presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, USA, 17-20 September 2007.
Results Reference
background
Citation
Debrus S et al. Viral shedding (methodology). Abstract presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, USA, 17-20 September 2007.
Results Reference
background
Citation
Vesikari T et al. Immunogenicity of liquid formulation of the oral live attenuated human rotavirus vaccine (Rotarix™). Abstract presented at the 12th Annual Congress of Sociedad Latinoamericana de Infectología Pediátrica (SLIPE). San Jose, Costa Rica 8-11 May 2007.
Results Reference
background
PubMed Identifier
21238572
Citation
Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 2011 Mar 3;29(11):2079-84. doi: 10.1016/j.vaccine.2011.01.004. Epub 2011 Jan 14.
Results Reference
derived
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104480
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
104480
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
104480
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
104480
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
104480
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104480
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

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