Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
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ClinicalTrials.gov Identifier: NCT00429481 |
Recruitment Status :
Completed
First Posted : January 31, 2007
Last Update Posted : September 16, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Biological: Rotarix | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2464 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age. |
Study Start Date : | January 2001 |
Actual Primary Completion Date : | April 2003 |
Actual Study Completion Date : | April 2003 |
- Occurrence of any RV GE
- Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),

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Ages Eligible for Study: | 11 Weeks to 17 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
- Written informed consent obtained from the parents or guardians of the subject.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
- Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
- 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 HIV infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- Household contact with an immunosuppressed individual or pregnant woman.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Previous confirmed occurrence of RV GE.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429481
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00429481 |
Other Study ID Numbers: |
444563/007 |
First Posted: | January 31, 2007 Key Record Dates |
Last Update Posted: | September 16, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Oral live attenuated human rotavirus vaccine Gastroenteritis Vomiting |
Hepatitis B Hepatitis Liver Diseases Digestive System Diseases |
Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human |