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A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

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: NCT00263666
Recruitment Status : Completed
First Posted : December 9, 2005
Results First Posted : March 13, 2009
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Rotavirus
Interventions Biological: Rotarix
Biological: Placebo
Biological: TritanrixTM-HB+Hib
Biological: SabinPolioTM vaccine
Enrollment 100
Recruitment Details  
Pre-assignment Details In case of discrepancy between the HIV results (DNA PCR positive, viral load negative), performed at the Screening Visit (one week prior to first vaccination) the infants were not enrolled in the study.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines. Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Period Title: Overall Study
Started 50 50
Completed 43 39
Not Completed 7 11
Reason Not Completed
Adverse Event             6             8
Lost to Follow-up             1             2
Withdrawal by Subject             0             1
Arm/Group Title Rotarix Group Placebo Group Total
Hide Arm/Group Description Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines. Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 50 participants 50 participants 100 participants
7.1  (1.10) 6.9  (1.02) 7.0  (1.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
28
  56.0%
25
  50.0%
53
  53.0%
Male
22
  44.0%
25
  50.0%
47
  47.0%
1.Primary Outcome
Title Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea.
Hide Description

Symptoms reported in the table include:

Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.

Time Frame Within the 15-day solicited follow-up period after any dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
26
  52.0%
28
  56.0%
2.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Symptoms.
Hide Description An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Within 30 days after each dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
47
  94.0%
48
  96.0%
3.Secondary Outcome
Title Number of Subjects Reporting Any Serious Adverse Events.
Hide Description

A serious adverse event (SAE) is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time Frame Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
17
  34.0%
12
  24.0%
4.Secondary Outcome
Title Number of Subjects Reporting Each Type of Solicited Symptom.
Hide Description Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.
Time Frame Within the 15-day solicited follow-up period after each dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Cough
35
  70.0%
31
  62.0%
Diarrhea
16
  32.0%
16
  32.0%
Fever
30
  60.0%
28
  56.0%
Irritability
31
  62.0%
28
  56.0%
Loss of appetite
23
  46.0%
23
  46.0%
Vomiting
19
  38.0%
15
  30.0%
5.Secondary Outcome
Title The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.
Hide Description Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.
Time Frame At the screening visit and 2 months after dose 3 (Visit 4).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Severe suppression at screening Number Analyzed 50 participants 50 participants
1
   2.0%
2
   4.0%
Moderate suppression at screening Number Analyzed 50 participants 50 participants
12
  24.0%
15
  30.0%
No suppression at screening Number Analyzed 50 participants 50 participants
37
  74.0%
33
  66.0%
Severe suppression at Visit 4 Number Analyzed 43 participants 39 participants
11
  25.6%
7
  17.9%
Moderate suppression at Visit 4 Number Analyzed 43 participants 39 participants
15
  34.9%
18
  46.2%
No suppression at Visit 4 Number Analyzed 43 participants 39 participants
13
  30.2%
10
  25.6%
Unknown at Visit 4 Number Analyzed 43 participants 39 participants
4
   9.3%
4
  10.3%
6.Secondary Outcome
Title Human Immunodeficiency Virus (HIV) Viral Load
Hide Description Mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).
Time Frame At the screening visit and 2 months after dose 3.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: base-10 logarithm of copies/milliliter
At screening Number Analyzed 50 participants 50 participants
5.7  (0.52) 5.7  (0.51)
Two months after dose 3 Number Analyzed 43 participants 36 participants
5.6  (0.77) 5.7  (0.51)
7.Secondary Outcome
Title Number of Subjects Who Seroconverted Against Rotavirus
Hide Description A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 21 22
Measure Type: Count of Participants
Unit of Measure: Participants
12
  57.1%
4
  18.2%
8.Secondary Outcome
Title Number of Subjects With Vaccine Take.
Hide Description Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.
Time Frame Two months after the dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 23 22
Measure Type: Count of Participants
Unit of Measure: Participants
15
  65.2%
7
  31.8%
9.Secondary Outcome
Title Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.
Hide Description Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis was performed on the According To Protocol Cohort for immunogenicity for whom data were available.

In the placebo group, GMCs were all < 20 U/ml, hence values were not computed.

Arm/Group Title Rotarix Group 1
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 21
Geometric Mean (95% Confidence Interval)
Unit of Measure: Units/milliliter
75.5
(29.1 to 195.7)
10.Secondary Outcome
Title Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.
Hide Description Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol Cohort for immunogenicity
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
≥ 0.15 µg/mL
20
  80.0%
23
  95.8%
≥ 1 µg/mL
20
  80.0%
22
  91.7%
11.Secondary Outcome
Title Geometric Mean Concentration for Anti-PRP Antibodies.
Hide Description [Not Specified]
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According to Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram/milliliter
4.641
(1.764 to 12.215)
4.865
(2.322 to 10.192)
12.Secondary Outcome
Title Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value
Hide Description The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL)
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-diphtheria
19
  76.0%
19
  76.0%
Anti-tetanus
23
  92.0%
24
  96.0%
13.Secondary Outcome
Title Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.
Hide Description [Not Specified]
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According to Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: International Units / milliliter
Anti-tetanus
1.457
(0.794 to 2.674)
1.035
(0.647 to 1.656)
Anti-diphtheria
0.283
(0.167 to 0.481)
0.219
(0.143 to 0.337)
14.Secondary Outcome
Title Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value
Hide Description The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 23 20
Measure Type: Count of Participants
Unit of Measure: Participants
15
  65.2%
11
  55.0%
15.Secondary Outcome
Title Geometric Mean Concentration for Anti-HBs Antibodies.
Hide Description [Not Specified]
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According to Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 23 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milli International Units/milliliter
25.6
(14.3 to 45.8)
18.9
(9.9 to 36.1)
16.Secondary Outcome
Title Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value
Hide Description The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter(EL.U/mL).
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
19
  76.0%
14
  58.3%
17.Secondary Outcome
Title Geometric Mean Concentration for Anti-BPT Antibodies.
Hide Description [Not Specified]
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According to Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: ELISA-Units/milliliter
28.8
(19.3 to 42.8)
18.1
(12.8 to 25.6)
18.Secondary Outcome
Title Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value
Hide Description The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-polio type 1 Number Analyzed 25 participants 24 participants
19
  76.0%
15
  62.5%
Anti-polio type 2 Number Analyzed 25 participants 24 participants
23
  92.0%
21
  87.5%
Anti-polio type 3 Number Analyzed 25 participants 23 participants
18
  72.0%
15
  65.2%
19.Secondary Outcome
Title Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.
Hide Description [Not Specified]
Time Frame Two months after dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According To Protocol cohort for immunogenicity
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Anti-polio 1 Number Analyzed 25 participants 24 participants
90.5
(36.4 to 225.3)
53.0
(19.4 to 144.5)
Anti-polio 2 Number Analyzed 25 participants 24 participants
142.6
(60.8 to 334.2)
252.4
(91.2 to 698.7)
Anti-polio 3 Number Analyzed 25 participants 23 participants
44.7
(19.2 to 104.2)
66.0
(22.6 to 192.2)
20.Secondary Outcome
Title Rotavirus Antigen Excretion in Stool Samples
Hide Description Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end
Time Frame At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According to Protocol Cohort for immunogenicity.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
11
  44.0%
5
  20.0%
21.Secondary Outcome
Title Rotavirus in Diarrheal Stool Samples
Hide Description Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.
Time Frame From Dose 1 until 2 months after dose 3 or until end of RV shedding
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Number of episodes
4 4
22.Secondary Outcome
Title Rotavirus Vaccine Strain Identification.
Hide Description

Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype.

Unknown: These samples were typed post hoc and found "G1P8" vaccine type for one subject in HRV group, "G3P8" and "G2P4" for subjects in placebo group.

Time Frame From dose 1 until 2 months after dose 3 or until end of RV shedding
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Number of episodes
G1WT+P8WT 2 0
G2+P4 0 1
G3+P8 0 1
GX+P6 1 0
Unknown 1 2
23.Secondary Outcome
Title Enteric Pathogens Identification.
Hide Description Number of gastroenteritis (GE) episodes classified by enteric pathogen tests results.
Time Frame From Dose 1 until 2 months after dose 3 or until end of RV shedding
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the subjects from the Total Vaccinated Cohort with gastroenteritis episodes reported between the first dose and the last visit and for whom stools were collected
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 29 34
Measure Type: Number
Unit of Measure: number of GE episodes
Campylobacter, negative 18 24
Campylobacter, positive 0 0
Campylobacter, unknown 11 10
E. histolytica, negative 18 24
E. histolytica, positive 0 0
E. histolytica, unknown 11 10
Salmonella, negative 17 24
Salmonella, positive 1 0
Salmonella, unknown 11 10
Sto Epec, negative 3 5
Sto Epec, positive 0 0
Sto Epec, unknown 26 29
Sto G.Lamblia, negative 18 24
Sto G.Lamblia, positive 0 0
Sto G.Lamblia, unknown 11 10
Sto Shigella, negative 18 24
Sto Shigella, positive 0 0
Sto Shigella, unknown 11 10
Sto Yersinia, negative 18 24
Sto Yersinia, positive 0 0
Sto Yersinia, unknown 11 10
24.Secondary Outcome
Title Number of Subjects With the RV in Stool Samples
Hide Description Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type and results not available [NA]).
Time Frame From Dose 1 until post Dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Overall Number of Participants Analyzed 26 7
Measure Type: Count of Participants
Unit of Measure: Participants
Dose 1 (Day 7; Yes ) Number Analyzed 9 participants 1 participants
7
  77.8%
0
   0.0%
Dose 1 (Day 7; No) Number Analyzed 9 participants 1 participants
0
   0.0%
0
   0.0%
Dose 1 (Day 7; NA) Number Analyzed 9 participants 1 participants
2
  22.2%
1
 100.0%
Dose 1 (Day 14; Yes) Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
Dose 1 (Day 14; No) Number Analyzed 4 participants 2 participants
0
   0.0%
1
  50.0%
Dose 1 (Day 14; Mixed) Number Analyzed 4 participants 2 participants
0
   0.0%
1
  50.0%
Dose 1 (Day 14; NA) Number Analyzed 4 participants 2 participants
4
 100.0%
0
   0.0%
Dose 1 (Day 21; Yes) Number Analyzed 5 participants 1 participants
1
  20.0%
0
   0.0%
Dose 1 (Day 21; No) Number Analyzed 5 participants 1 participants
0
   0.0%
1
 100.0%
Dose 1 (Day 21; NA) Number Analyzed 5 participants 1 participants
4
  80.0%
0
   0.0%
Dose 2 (Day 7; Yes) Number Analyzed 26 participants 1 participants
NA [1] 
0
   0.0%
Dose 2 (Day 7; No) Number Analyzed 26 participants 1 participants
NA [1] 
1
 100.0%
Dose 2 (Day 7; NA) Number Analyzed 26 participants 1 participants
NA [1] 
0
   0.0%
Dose 2 (Day 14; Yes) Number Analyzed 1 participants 7 participants
0
   0.0%
NA [1] 
Dose 2 (Day 14; No) Number Analyzed 1 participants 7 participants
0
   0.0%
NA [1] 
Dose 2 (Day 14; NA) Number Analyzed 1 participants 7 participants
1
 100.0%
NA [1] 
Dose 2 (Day 21; Yes) Number Analyzed 2 participants 7 participants
0
   0.0%
NA [1] 
Dose 2 (Day 21; No) Number Analyzed 2 participants 7 participants
0
   0.0%
NA [1] 
Dose 2 (Day 21; NA) Number Analyzed 2 participants 7 participants
2
 100.0%
NA [1] 
Dose 3 (Day 7; Yes) Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Dose 3 (Day 7; No) Number Analyzed 1 participants 1 participants
0
   0.0%
1
 100.0%
Dose 3 (Day 7; NA) Number Analyzed 1 participants 1 participants
1
 100.0%
0
   0.0%
Dose 3 (Day 14; Yes) Number Analyzed 2 participants 7 participants
2
 100.0%
NA [1] 
Dose 3 (Day 14; No) Number Analyzed 2 participants 7 participants
0
   0.0%
NA [1] 
Dose 3 (Day 14; NA) Number Analyzed 2 participants 7 participants
0
   0.0%
NA [1] 
Dose 3 (Day 42; Yes) Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Dose 3 (Day 42; No) Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Dose 3 (Day 42; NA) Number Analyzed 1 participants 1 participants
1
 100.0%
1
 100.0%
Post Dose 3 (Day 0; Yes) Number Analyzed 1 participants 7 participants
0
   0.0%
NA [1] 
Post Dose 3 (Day 0; No) Number Analyzed 1 participants 7 participants
0
   0.0%
NA [1] 
Post Dose 3 (Day 0; NA) Number Analyzed 1 participants 7 participants
1
 100.0%
NA [1] 
[1]
No stool samples collected
Time Frame Solicited general symptoms during the 15-day (Days 0-14) post-vaccination period following each dose and across doses, unsolicited AEs within 31 days (Days 0-30) after any vaccination and SAEs throughout the study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotarix Group Placebo Group
Hide Arm/Group Description Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines. Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
All-Cause Mortality
Rotarix Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Rotarix Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   17/50 (34.00%)   12/50 (24.00%) 
Blood and lymphatic system disorders     
Anemia * 1  1/50 (2.00%)  1/50 (2.00%) 
Eye disorders     
Conjunctivitis * 1  1/50 (2.00%)  0/50 (0.00%) 
Gastrointestinal disorders     
Ileus paralytic * 1  1/50 (2.00%)  0/50 (0.00%) 
General disorders     
Sudden infant death syndrome * 1  0/50 (0.00%)  1/50 (2.00%) 
Hepatobiliary disorders     
Jaundice * 1  0/50 (0.00%)  1/50 (2.00%) 
Infections and infestations     
Bronchiolitis * 1  1/50 (2.00%)  0/50 (0.00%) 
Bronchopneumonia * 1  7/50 (14.00%)  4/50 (8.00%) 
Lobar pneumonia * 1  0/50 (0.00%)  1/50 (2.00%) 
Pneumocystis jiroveci pneumonia * 1  2/50 (4.00%)  2/50 (4.00%) 
Pneumonia * 1  1/50 (2.00%)  3/50 (6.00%) 
Lymph node tuberculosis * 1  0/50 (0.00%)  1/50 (2.00%) 
Pulmonary tuberculosis * 1  0/50 (0.00%)  1/50 (2.00%) 
Tuberculosis * 1  1/50 (2.00%)  0/50 (0.00%) 
Dysentery * 1  0/50 (0.00%)  1/50 (2.00%) 
Gastroenteritis * 1  6/50 (12.00%)  3/50 (6.00%) 
HIV infection * 1  1/50 (2.00%)  0/50 (0.00%) 
Meningitis * 1  1/50 (2.00%)  0/50 (0.00%) 
Oral candidiasis * 1  1/50 (2.00%)  0/50 (0.00%) 
Otitis media * 1  2/50 (4.00%)  0/50 (0.00%) 
Sepsis * 1  3/50 (6.00%)  0/50 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/50 (4.00%)  1/50 (2.00%) 
Electrolyte imbalance * 1  0/50 (0.00%)  1/50 (2.00%) 
Marasmus * 1  0/50 (0.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  0/50 (0.00%)  1/50 (2.00%) 
Pneumonia aspiration * 1  1/50 (2.00%)  0/50 (0.00%) 
Respiratory failure * 1  0/50 (0.00%)  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotarix Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   48/50 (96.00%)   47/50 (94.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  5/50 (10.00%)  3/50 (6.00%) 
Splenomegaly * 1  2/50 (4.00%)  4/50 (8.00%) 
Gastrointestinal disorders     
Constipation * 1  1/50 (2.00%)  3/50 (6.00%) 
Vomiting * 1  1/50 (2.00%)  5/50 (10.00%) 
Abdominal pain * 1  2/50 (4.00%)  3/50 (6.00%) 
General disorders     
Pyrexia * 1  3/50 (6.00%)  6/50 (12.00%) 
Cough   35/50 (70.00%)  31/50 (62.00%) 
Diarrhoea   16/50 (32.00%)  16/50 (32.00%) 
Fever   30/50 (60.00%)  28/50 (56.00%) 
Irritability   31/50 (62.00%)  28/50 (56.00%) 
Loss of appetite   23/50 (46.00%)  23/50 (46.00%) 
Vomiting   19/50 (38.00%)  15/50 (30.00%) 
Infections and infestations     
Upper respiratory tract infection * 1  18/50 (36.00%)  14/50 (28.00%) 
Pulmonary tuberculosis * 1  2/50 (4.00%)  3/50 (6.00%) 
Influenza * 1  6/50 (12.00%)  0/50 (0.00%) 
Pharyngitis * 1  1/50 (2.00%)  3/50 (6.00%) 
Investigations     
Weight decreased * 1  1/50 (2.00%)  4/50 (8.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/50 (2.00%)  5/50 (10.00%) 
Nasal congestion * 1  4/50 (8.00%)  4/50 (8.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis * 1  4/50 (8.00%)  4/50 (8.00%) 
Dermatitis diaper * 1  5/50 (10.00%)  4/50 (8.00%) 
Eczema * 1  2/50 (4.00%)  8/50 (16.00%) 
Rash * 1  4/50 (8.00%)  2/50 (4.00%) 
Rash papular * 1  0/50 (0.00%)  3/50 (6.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00263666    
Other Study ID Numbers: 444563/022
First Submitted: December 8, 2005
First Posted: December 9, 2005
Results First Submitted: February 13, 2009
Results First Posted: March 13, 2009
Last Update Posted: August 20, 2018