Infections, Rotavirus Clinical Trial
Official title:
A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose
Verified date | May 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.
Status | Completed |
Enrollment | 360 |
Est. completion date | September 8, 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Weeks to 12 Weeks |
Eligibility |
"Inclusion criteria: - A male or female between, and including, 8 and 10 weeks of age at the time of the first vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - The subjects should have been administered the first dose of DTP/ OPV/ hepatitis B vaccines as per the local universal immunization program at 6 weeks of age. Exclusion criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or the routine UIP vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. - 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 chronic drug therapy to be continued during the study period. - Administration of a vaccine not foreseen by the study protocol within 6 weeks of the first dose of vaccine or planned administration during the study of a vaccine not foreseen by the study protocol, with the exception of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), OPV and vaccination against tuberculosis, which can be given with at least two weeks separation from the first and subsequent dose of the study vaccine. - Prior administration of experimental rotavirus vaccine. - History of confirmed rotavirus gastroenteritis. - 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 based on physical examination (no laboratory testing is required). - A family history of congenital or hereditary immunodeficiency. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. - Major congenital defects or serious chronic illness. - History of any neurologic disorders or seizures. - Acute disease at the time of enrolment. - Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history. - Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via breastfeeding is allowed. |
Country | Name | City | State |
---|---|---|---|
India | GSK Investigational Site | Chandigarth | |
India | GSK Investigational Site | Kolkata | |
India | GSK Investigational Site | Pune | |
India | GSK Investigational Site | Vellore, |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
India,
Bhattacharya SK et al. Immune response in infants sero-positive at pre-vaccination human rotavirus vaccine Rotarix™. Poster presented at WSPID, Bangkok, Thailand,15-18 November 2007
Bose et al. Safety and immunogenicity of RIX4414 (Rotarix TM) live-attenuated human rotavirus vaccine in Indian infants. Poster presented at WSPID, Bangkok, Thailand, 15-18 November 2007.
Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, Bock HL. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccin. 2009 Jun;5(6):414-9. Epub 2009 Jun 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo. | |||
Secondary | Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01435967 -
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
|
N/A | |
Completed |
NCT00370318 -
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
|
Phase 3 | |
Completed |
NCT00345956 -
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
|
Phase 3 | |
Completed |
NCT00140686 -
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
|
Phase 3 | |
Completed |
NCT00383903 -
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
|
Phase 2 | |
Completed |
NCT00750893 -
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
|
||
Completed |
NCT00533507 -
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age
|
Phase 3 | |
Completed |
NCT00363545 -
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
|
Phase 3 | |
Completed |
NCT02914184 -
Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
|
Phase 3 | |
Completed |
NCT00489567 -
Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden
|
N/A | |
Completed |
NCT01733862 -
Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
|
||
Completed |
NCT00779779 -
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
|
||
Completed |
NCT00382772 -
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
|
Phase 3 | |
Completed |
NCT00729001 -
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
|
Phase 2 | |
Completed |
NCT00353366 -
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
|
||
Completed |
NCT01198769 -
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
|
Phase 4 | |
Completed |
NCT00385320 -
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
|
Phase 2 | |
Completed |
NCT00432380 -
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
|
Phase 2 | |
Completed |
NCT01563159 -
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011
|
N/A | |
Completed |
NCT01339221 -
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
|
N/A |