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

Phase 3

Completed

• Conditions: Infections, Rotavirus
• Interventions: Biological: Lyophilized formulation of HRV vaccine; Biological: Liquid formulation of HRV vaccine

• Registration Number: NCT00363545
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Study Start: 2006-09-01
• Primary Completion: 2007-04-12
• Study Completion: 2007-04-12
• Results First Submitted: 2017-01-05
• Results First Submitted QC: 2017-01-05
• Results First Posted: 2017-02-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1274

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lyophilized Rotarix Group	Lyophilized formulation of HRV vaccine	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.
Liquid Rotarix Group	Liquid formulation of HRV vaccine	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.

Primary Outcome Measures

Name	Time	Method
Number of Seroconverted Subjects Against Human Rotavirus	At 1 to 2 months after the second vaccine dose (Months 3-4)	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.

Secondary Outcome Measures

Name	Time	Method
Concentrations of Anti-rotavirus IgA Antibodies	At 1 to 2 months after the second vaccine dose (Months 3-4)	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).
Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies	At 1 to 2 months after the second vaccine dose (Months 3-4)	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.
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.	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.
Number of Subjects With Unsolicited Adverse Events (AEs)	Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months	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.
Number of Subjects With Serious Adverse Events (SAEs)	Throughout the entire study period (from Day 0 to Month 4)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes	From the first vaccine dose (Dose 1) up to Month 4	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇦 Panama, Panama