A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00140673
• Date of registration: 31/08/2005
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
• Scientific title: A Placebo-controlled, Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
• Date of first enrolment: August 5, 2003
• Target sample size: 63227
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00140673
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Chile, Colombia, Dominican Republic, Finland, Honduras, Mexico, Nicaragua, Panama, Peru, Venezuela

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- Healthy infants 6-13 weeks of age at the time of the first study vaccination whose
parent/guardian sign a written informed consent and whose parents/guardians can and
will comply with the requirements of the protocol (e.g., completion of the diary
cards, return for follow-up visits)

Exclusion criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo,
or planned use during the study period

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth. (Topical steroids are allowed.)

- Child is unlikely to remain in the study area for the duration of the study

- 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

- Administration of immunoglobulins and/or blood products since birth or planned
administration during the study period

- Any clinically significant history of chronic gastrointestinal disease including any
uncorrected congenital malformation of the gastrointestinal tract or other serious
medical condition as determined by the investigator



Age minimum: 6 Weeks
Age maximum: 13 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Rotavirus

Intervention(s)

Biological: Rotavirus

Primary Outcome(s)

1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Secondary Outcome(s)

SAEs.

Severe RV GE by wild-type G1, non-G1, each non-G1, 11 score after Dose 2 and Dose 1 until 1-year old.

Severe RV GE in subset during the 2nd year and both years.

Definite IS until 1-year old and 2-years old.

Serum anti-RV IgA at Visits 1 and 3 (subset/country except Finland).

Secondary ID(s)

444563/023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors