Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00425737

Enrollment

405

Registered

2007-01-23

Start date

2000-08-31

Completion date

2001-07-31

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Rotavirus

Keywords

Oral live attenuated human rotavirus vaccine, Gastroenteritis

Brief summary

To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus

Interventions

BIOLOGICALRotarix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parents or guardians of the subject. * Born after a normal gestation period (between 36 and 42 weeks).

Exclusion criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period. * 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 or other serious medical condition as determined by the investigator. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). * Household contact with an immunosuppressed individual or pregnant woman. * Abnormal stool pattern. * Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. * Previous confirmed occurrence of rotavirus gastroenteritis.

Design outcomes

Primary

Measure	Time frame
Occurrence of RV GE	—

Secondary

Measure	Time frame
Occurrence of severe RV GE, solicited symptoms (Day 0-14), unsolicited Adverse Events (Day 0-42), Serious Adverse Events (full study), presence of rotavirus antigen in stool samples, immunogenicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026