To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

NCT00363545 | Completed Phase 3 Results

• 1 other identifier: 107077
• Study Type: interventional
• Target: 1,274
• Locations: 1 country
• Sites: 3

Brief Summary

This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine

Conditions

Infections, Rotavirus

Keywords

Prophylaxis against gastroenteritis caused by Rotavirus

Outcome Measures

Primary Outcomes (1)

• Number of Seroconverted Subjects Against Human Rotavirus

  A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.

  At 1 to 2 months after the second vaccine dose (Months 3-4)

Secondary Outcomes (6)

• Concentrations of Anti-rotavirus IgA Antibodies

  At 1 to 2 months after the second vaccine dose (Months 3-4)

• Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies

  At 1 to 2 months after the second vaccine dose (Months 3-4)

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.

• Number of Subjects With Unsolicited Adverse Events (AEs)

  Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months

• Number of Subjects With Serious Adverse Events (SAEs)

  Throughout the entire study period (from Day 0 to Month 4)

Study Arms (2)

Liquid Rotarix Group

EXPERIMENTAL

Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.

Biological: Liquid formulation of HRV vaccine

Lyophilized Rotarix Group

EXPERIMENTAL

Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.

Biological: Lyophilized formulation of HRV vaccine

Interventions

Lyophilized formulation of HRV vaccine BIOLOGICAL

Lyophilized formulation of HRV vaccine

Lyophilized Rotarix Group

Liquid formulation of HRV vaccine BIOLOGICAL

Liquid formulation of HRV vaccine

Liquid Rotarix Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
• Written informed consent obtained from the parent or guardian of the subject.

You may not qualify if:

• se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Household contact with an immunosuppressed individual or pregnant women.
• Previous confirmed occurrence of RV GE.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

David, Panama

Location

GSK Investigational Site

La Chorrera, Panama

Location

GSK Investigational Site

Panama City, Panama

Location

Related Publications (1)

• Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Primary Completion: April 12, 2007
• Study Completion: April 12, 2007
• Last Updated: June 8, 2018
• Results First Posted: February 23, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

PA (3)