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Trial record 64 of 281 for:    Panama

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363545
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : February 23, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Rotavirus
Interventions Biological: Lyophilized formulation of HRV vaccine
Biological: Liquid formulation of HRV vaccine
Enrollment 1274
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 636 638
Completed 592 581
Not Completed 44 57
Reason Not Completed
Serious Adverse Event             0             1
Withdrawal by Subject             12             15
Migrated/moved from study area             3             6
Lost to follow-up (incompl. vaccination)             14             18
Lost to follow-up (complete vaccination)             14             17
Others             1             0
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 636 638 1274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 636 participants 638 participants 1274 participants
8.6  (0.87) 8.6  (0.86) 8.6  (0.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 636 participants 638 participants 1274 participants
Female
294
  46.2%
316
  49.5%
610
  47.9%
Male
342
  53.8%
322
  50.5%
664
  52.1%
1.Primary Outcome
Title Number of Seroconverted Subjects Against Human Rotavirus
Hide Description 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.
Time Frame At 1 to 2 months after the second vaccine dose (Months 3-4)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 449 434
Measure Type: Number
Unit of Measure: Subjects
363 319
2.Secondary Outcome
Title Concentrations of Anti-rotavirus IgA Antibodies
Hide Description 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).
Time Frame At 1 to 2 months after the second vaccine dose (Months 3-4)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 449 434
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
151.2
(128.0 to 178.7)
111.7
(93.5 to 133.4)
3.Secondary Outcome
Title Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies
Hide Description 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.
Time Frame At 1 to 2 months after the second vaccine dose (Months 3-4)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity stool analysis subset, defined as the first 200 subjects for whom pre-vaccination stool samples were available and with available anti-rotavirus IgA antibody results at post sampling time point or with vaccine virus in stools collected after the first vaccine dose up to Month 4.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 81 71
Measure Type: Number
Unit of Measure: Subjects
67 51
4.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description 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.
Time Frame During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 636 638
Measure Type: Number
Unit of Measure: Subjects
Any Cough/runny nose, Dose 1 Number Analyzed 636 participants 638 participants
234 252
Grade 3 Cough/runny nose, Dose 1 Number Analyzed 636 participants 638 participants
22 20
Related Cough/runny nose, Dose 1 Number Analyzed 636 participants 638 participants
31 22
Any Diarrhea, Dose 1 Number Analyzed 636 participants 638 participants
43 34
Grade 3 Diarrhea, Dose 1 Number Analyzed 636 participants 638 participants
8 11
Related Diarrhea, Dose 1 Number Analyzed 636 participants 638 participants
19 14
Any Fever (Rectal), Dose 1 Number Analyzed 636 participants 638 participants
296 292
Grade 3 Fever (Rectal), Dose 1 Number Analyzed 636 participants 638 participants
12 12
Related Fever (Rectal), Dose 1 Number Analyzed 636 participants 638 participants
148 161
Any Irr./Fuss., Dose 1 Number Analyzed 636 participants 638 participants
343 352
Grade 3 Irr./Fuss., Dose 1 Number Analyzed 636 participants 638 participants
35 35
Related Irr./Fuss., Dose 1 Number Analyzed 636 participants 638 participants
150 156
Any Loss of appetite, Dose 1 Number Analyzed 636 participants 638 participants
152 163
Grade 3 Loss of appetite, Dose 1 Number Analyzed 636 participants 638 participants
8 6
Related Loss of appetite, Dose 1 Number Analyzed 636 participants 638 participants
48 55
Any Vomiting, Dose 1 Number Analyzed 636 participants 638 participants
131 129
Grade 3 Vomiting, Dose 1 Number Analyzed 636 participants 638 participants
36 27
Related Vomiting, Dose 1 Number Analyzed 636 participants 638 participants
24 20
Any Cough/runny nose, Dose 2 Number Analyzed 605 participants 597 participants
239 239
Grade 3 Cough/runny nose, Dose 2 Number Analyzed 605 participants 597 participants
19 23
Related Cough/runny nose, Dose 2 Number Analyzed 605 participants 597 participants
31 42
Any Diarrhea, Dose 2 Number Analyzed 605 participants 597 participants
23 27
Grade 3 Diarrhea, Dose 2 Number Analyzed 605 participants 597 participants
5 9
Related Diarrhea, Dose 2 Number Analyzed 605 participants 597 participants
7 5
Any Fever (Rectal), Dose 2 Number Analyzed 605 participants 597 participants
283 274
Grade 3 Fever (Rectal), Dose 2 Number Analyzed 605 participants 597 participants
23 14
Related Fever (Rectal), Dose 2 Number Analyzed 605 participants 597 participants
139 148
Any Irr./Fuss., Dose 2 Number Analyzed 605 participants 597 participants
280 298
Grade 3 Irr./Fuss., Dose 2 Number Analyzed 605 participants 597 participants
31 23
Related Irr./Fuss., Dose 2 Number Analyzed 605 participants 597 participants
137 155
Any Loss of appetite, Dose 2 Number Analyzed 605 participants 597 participants
136 138
Grade 3 Loss of appetite, Dose 2 Number Analyzed 605 participants 597 participants
8 6
Related Loss of appetite, Dose 2 Number Analyzed 605 participants 597 participants
45 61
Any Vomiting, Dose 2 Number Analyzed 605 participants 597 participants
85 82
Grade 3 Vomiting, Dose 2 Number Analyzed 605 participants 597 participants
20 22
Related Vomiting, Dose 2 Number Analyzed 605 participants 597 participants
5 7
Any Cough/runny nose, Across doses Number Analyzed 636 participants 638 participants
335 342
Grade 3 Cough/runny nose, Across doses Number Analyzed 636 participants 638 participants
36 41
Related Cough/runny nose, Across doses Number Analyzed 636 participants 638 participants
56 58
Any Diarrhea, Across doses Number Analyzed 636 participants 638 participants
61 59
Grade 3 Diarrhea, Across doses Number Analyzed 636 participants 638 participants
13 20
Related Diarrhea, Across doses Number Analyzed 636 participants 638 participants
24 19
Any Fever (Rectal), Across doses Number Analyzed 636 participants 638 participants
405 406
Grade 3 Fever (Rectal), Across doses Number Analyzed 636 participants 638 participants
34 26
Related Fever (Rectal), Across doses Number Analyzed 636 participants 638 participants
220 240
Any Irr./Fuss., Across doses Number Analyzed 636 participants 638 participants
401 427
Grade 3 Irr./Fuss., Across doses Number Analyzed 636 participants 638 participants
55 49
Related Irr./Fuss., Across doses Number Analyzed 636 participants 638 participants
211 238
Any Loss of appetite, Across doses Number Analyzed 636 participants 638 participants
218 234
Grade 3 Loss of appetite, Across doses Number Analyzed 636 participants 638 participants
16 11
Related Loss of appetite, Across doses Number Analyzed 636 participants 638 participants
83 95
Any Vomiting, Across doses Number Analyzed 636 participants 638 participants
162 167
Grade 3 Vomiting, Across doses Number Analyzed 636 participants 638 participants
44 43
Related Vomiting, Across doses Number Analyzed 636 participants 638 participants
29 26
5.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 636 638
Measure Type: Number
Unit of Measure: Subjects
276 285
6.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Throughout the entire study period (from Day 0 to Month 4)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 636 638
Measure Type: Number
Unit of Measure: Subjects
37 38
7.Secondary Outcome
Title Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes
Hide Description 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.
Time Frame From the first vaccine dose (Dose 1) up to Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 636 638
Measure Type: Number
Unit of Measure: Subjects
Dose 1-Dose 2 (N=636;638) 4 2
Dose 2-Visit 3 (N=605;597) 1 0
Dose 1-Visit 3 (N=636;638) 5 2
Time Frame Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liquid Rotarix Group Lyophilized Rotarix Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Liquid Rotarix Group Lyophilized Rotarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liquid Rotarix Group Lyophilized Rotarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   37/636 (5.82%)   38/638 (5.96%) 
Cardiac disorders     
Cardio-respiratory arrest  1  1/636 (0.16%)  0/638 (0.00%) 
Sinus tachycardia  1  0/636 (0.00%)  1/638 (0.16%) 
Gastrointestinal disorders     
Gastro esophageal reflux disease  1  3/636 (0.47%)  1/638 (0.16%) 
Vomiting  1  1/636 (0.16%)  0/638 (0.00%) 
Immune system disorders     
Milk allergy  1  0/636 (0.00%)  1/638 (0.16%) 
Infections and infestations     
Bronchiolitis  1  22/636 (3.46%)  20/638 (3.13%) 
Pneumonia  1  10/636 (1.57%)  7/638 (1.10%) 
Gastroenteritis  1  4/636 (0.63%)  6/638 (0.94%) 
Bronchopneumonia  1  3/636 (0.47%)  4/638 (0.63%) 
Urinary tract infection  1  1/636 (0.16%)  2/638 (0.31%) 
Enterococcal sepsis  1  1/636 (0.16%)  0/638 (0.00%) 
Escherichia urinary tract infection  1  1/636 (0.16%)  0/638 (0.00%) 
Omphalitis  1  1/636 (0.16%)  0/638 (0.00%) 
Pertussis  1  0/636 (0.00%)  1/638 (0.16%) 
Metabolism and nutrition disorders     
Dehydration  1  1/636 (0.16%)  0/638 (0.00%) 
Nervous system disorders     
Hypoxic encephalopathy  1  1/636 (0.16%)  0/638 (0.00%) 
Infantile spasms  1  1/636 (0.16%)  0/638 (0.00%) 
Renal and urinary disorders     
Nephropathy toxic  1  1/636 (0.16%)  0/638 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthmatic crisis  1  1/636 (0.16%)  2/638 (0.31%) 
Asthma  1  2/636 (0.31%)  0/638 (0.00%) 
Bronchial obstruction  1  0/636 (0.00%)  1/638 (0.16%) 
Tracheomalacia  1  1/636 (0.16%)  0/638 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liquid Rotarix Group Lyophilized Rotarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   553/636 (86.95%)   556/638 (87.15%) 
General disorders     
Cough/runny nose  1  335/636 (52.67%)  342/638 (53.61%) 
Diarrhea  1  61/636 (9.59%)  59/638 (9.25%) 
Fever (Rectal)  1  405/636 (63.68%)  406/638 (63.64%) 
Irritability/ Fussiness  1  401/636 (63.05%)  427/638 (66.93%) 
Loss of appetite  1  218/636 (34.28%)  234/638 (36.68%) 
Vomiting  1  162/636 (25.47%)  167/638 (26.18%) 
Infections and infestations     
Nasopharyngitis  1  164/636 (25.79%)  162/638 (25.39%) 
Bronchiolitis  1  38/636 (5.97%)  48/638 (7.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
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.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363545     History of Changes
Other Study ID Numbers: 107077
First Submitted: August 11, 2006
First Posted: August 15, 2006
Results First Submitted: January 5, 2017
Results First Posted: February 23, 2017
Last Update Posted: June 8, 2018