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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00429481

Enrollment

2464

Registered

2007-01-31

Start date

2001-01-31

Completion date

2003-04-30

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

Hepatitis B

Keywords

Oral live attenuated human rotavirus vaccine, Gastroenteritis, Vomiting

Brief summary

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.

Interventions

BIOLOGICALRotarix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

11 Weeks to 17 Weeks

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of any RV GE	—

Secondary

Measure	Time frame
Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),	—

Outcome results

None listed

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