Clinical trials: Rotavirus Infections
Infections, Rotavirus
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
- Trial name
- NCT00938327
- Testing
- Rotarix™
- Where
- 12 sites in India
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
- Trial name
- NCT00429481
- Testing
- Rotarix
- Volunteers
- 2,464 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan.
- Trial name
- NCT03954743
- Testing
- PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 1,351 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in…
- Trial name
- NCT01511133
- Testing
- Stool sample, Serum sample
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Rotavirus
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.
- Trial name
- NCT01253967
- Testing
- Collection of stool samples, Health economics questionnaire
- Where
- 8 sites in Romania
- Volunteers
- 1,234 people
- Sponsor
- GlaxoSmithKline
Rotavirus Infection, Adenoviridae Infection
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
- Conditions
- Rotavirus Infection, Adenoviridae Infection, Norovirus Infection
- Trial name
- NCT00302640
- Testing
- Alinia (nitazoxanide)
- Volunteers
- 50 people
- Sponsor
- Romark Laboratories L.C.
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human…
- Trial name
- NCT00329745
- Testing
- Rotarix™
- Where
- 4 sites in Singapore
- Volunteers
- 8,687 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
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…
- Trial name
- NCT00289172
- Testing
- Live attenuated human rotavirus vaccine
- Where
- 4 sites in India
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
- Trial name
- NCT00334607
- Testing
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Where
- 42 sites in United States
- Volunteers
- 484 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Infection, Rotavirus Vaccines
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
The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely…
- Trial name
- NCT03207750
- Testing
- Rotarix, Pediarix, Hiberix
- Where
- 47 sites in United States
- Volunteers
- 1,280 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium
This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in…
- Trial name
- NCT01592838
- Testing
- Data collection
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
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…
- Trial name
- NCT01198769
- Testing
- Rotarix TM
- Where
- Taiwan
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK…
- Trial name
- NCT00197210
- Testing
- Rotavirus
- Where
- 4 sites in Singapore
- Volunteers
- 10,708 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
- Trial name
- NCT00432380
- Testing
- Rotarix™
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh
The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).
- Trial name
- NCT00139334
- Testing
- Rotavirus
- Where
- Bangladesh
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™
The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis.
- Trial name
- NCT01435967
- Testing
- Data collection
- Where
- 8 sites in Belgium
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least…
- Trial name
- NCT00750893
- Testing
- Rotarix or Rotarix liquid formulation
- Where
- South Korea
- Volunteers
- 3,111 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline