To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
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|ClinicalTrials.gov Identifier: NCT00363545|
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : February 23, 2017
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infections, Rotavirus||Biological: Lyophilized formulation of HRV vaccine Biological: Liquid formulation of HRV vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1274 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 1, 2006|
|Actual Primary Completion Date :||April 12, 2007|
|Actual Study Completion Date :||April 12, 2007|
Experimental: Liquid Rotarix Group
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
Liquid formulation of HRV vaccine
Experimental: Lyophilized Rotarix Group
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
Lyophilized formulation of HRV vaccine
- Number of Seroconverted Subjects Against Human Rotavirus [ Time Frame: 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.
- Concentrations of Anti-rotavirus IgA Antibodies [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363545
|GSK Investigational Site|
|GSK Investigational Site|
|La Chorrera, Panama|
|GSK Investigational Site|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|