Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
NCT01198769 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2018-08-20
Summary
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.
Conditions
- Infections, Rotavirus
Interventions
- BIOLOGICAL
-
Rotarix TM
Oral, 2 doses
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 12 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-11-11
- Primary Completion
- 2011-04-18
- Completion
- 2011-04-18
Countries
- Taiwan
Study Locations
More Related Trials
-
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
NCT00317122 ·Status: COMPLETED ·Phase: PHASE3
-
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
NCT00429481 ·Status: COMPLETED ·Phase: PHASE2
-
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
NCT02914184 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
NCT00480324 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
NCT00432380 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
NCT00317135 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
NCT00779779 ·Status: COMPLETED
-
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
NCT00757770 ·Status: COMPLETED ·Phase: PHASE3
-
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
NCT00290303 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
NCT01171963 ·Status: COMPLETED ·Phase: PHASE3
-
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
NCT00158756 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
NCT00750893 ·Status: COMPLETED
-
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
NCT02907216 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
NCT06025695 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
NCT00875641 ·Status: COMPLETED
-
Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants
NCT01616459 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
NCT00317187 ·Status: COMPLETED ·Phase: PHASE3
-
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
NCT00289172 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
NCT00317161 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
NCT00879827 ·Status: COMPLETED ·Phase: PHASE3
-
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
NCT00938327 ·Status: COMPLETED
-
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
NCT02153333 ·Status: COMPLETED
-
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
NCT00353366 ·Status: COMPLETED
-
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
NCT00291967 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
NCT00385320 ·Status: COMPLETED ·Phase: PHASE2