NCT Number: NCT00385320
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
Looking for future studies?
Notify MeKey information
Conditions
Age range
6 week–12 week
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion criteria
- Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
- Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
- History of allergic disease
- 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.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
- Previous confirmed occurrence of RV GE.
- Household contact with an immunosuppressed individual or pregnant women.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
Treatment and study plan
Primary outcomes
-
Occurrence of RV GE
Secondary outcomes
-
Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study title
To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.
Important dates
- Study start
- 2001
- Primary completion
- 2003
- Study completion
- 2003
- First posted
- Oct 9, 2006
- Registry last updated
- Dec 27, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
NCT03954743
Infections, Infections, Rotavirus
Birmingham, Alabama, United States
View Trial DetailsTo Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
NCT00353366
Digestive System Diseases, Gastroenteritis
Alabang, Muntinlupa City, Philippines
View Trial DetailsA Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
NCT00263666
Infections, Infections, Rotavirus
Attridgerville, Gauteng, South Africa
View Trial DetailsEvaluation 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
Infections, Infections, Rotavirus
Birmingham, Alabama, United States
View Trial Details