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 · Type: INTERVENTIONAL · Enrollment: 2640
Last updated 2019-12-27
Summary
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
Conditions
- Infections, Rotavirus
Interventions
- BIOLOGICAL
-
HRV vaccine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 12 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2001-05-31
- Primary Completion
- 2003-04-30
- Completion
- 2003-04-30
More Related Trials
-
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
NCT03954743 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa
NCT00383903 ·Status: COMPLETED ·Phase: PHASE2
-
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
NCT00139347 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
NCT00382772 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
NCT00137930 ·Status: COMPLETED ·Phase: PHASE2
-
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
NCT00757770 ·Status: COMPLETED ·Phase: PHASE3
-
Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
NCT00134732 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
NCT00345956 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
NCT02141204 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
NCT00969228 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
NCT01107587 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
NCT00140686 ·Status: COMPLETED ·Phase: PHASE3
-
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
NCT00346892 ·Status: COMPLETED ·Phase: PHASE2
-
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
NCT00420316 ·Status: COMPLETED ·Phase: PHASE3
-
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
NCT03207750 ·Status: COMPLETED ·Phase: PHASE3
-
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
NCT00334607 ·Status: COMPLETED ·Phase: PHASE3
-
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
NCT00363545 ·Status: COMPLETED ·Phase: PHASE3
-
Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants
NCT00169455 ·Status: COMPLETED ·Phase: PHASE3
-
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
NCT00420745 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
NCT00480324 ·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
-
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
NCT02153333 ·Status: COMPLETED
-
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
NCT00241644 ·Status: COMPLETED ·Phase: PHASE3