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

Infections, Rotavirus Clinical Trial

Official title:

A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363545
• Other study ID #: 107077
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2006
• Est. completion date: April 12, 2007

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1274
• Est. completion date: April 12, 2007
• Est. primary completion date: April 12, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• Lyophilized formulation of HRV vaccine
Lyophilized formulation of HRV vaccine
• Liquid formulation of HRV vaccine
Liquid formulation of HRV vaccine

Locations

Country	Name	City	State
Panama	GSK Investigational Site	David
Panama	GSK Investigational Site	La Chorrera
Panama	GSK Investigational Site	Panama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Concentrations of Anti-rotavirus IgA Antibodies	Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).	At 1 to 2 months after the second vaccine dose (Months 3-4)
Secondary	Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies	Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of = 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.	At 1 to 2 months after the second vaccine dose (Months 3-4)
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were cough/runny nose, diarrhea, fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (=) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (=) 3 episodes of vomiting/day. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	Throughout the entire study period (from Day 0 to Month 4)
Secondary	Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes	The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.	From the first vaccine dose (Dose 1) up to Month 4

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