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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00263666
First received: December 8, 2005
Last updated: October 27, 2011
Last verified: October 2011
Results First Received: February 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Rotavirus Gastroenteritis
Interventions: Biological: Rotarix
Biological: Placebo
Biological: TritanrixTM-HB+Hib
Biological: SabinPolioTM vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Participant Flow:   Overall Study
    Rotarix Group     Placebo Group  
STARTED     50     50  
COMPLETED     43     39  
NOT COMPLETED     7     11  
Adverse Event                 6                 8  
Lost to Follow-up                 1                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Total Total of all reporting groups

Baseline Measures
    Rotarix Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: weeks]
Mean ± Standard Deviation
  7.1  ± 1.10     6.9  ± 1.02     7.0  ± 1.06  
Gender  
[units: participants]
     
Female     28     25     53  
Male     22     25     47  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.   [ Time Frame: Within the 15-day solicited follow-up period after any dose. ]

Measure Type Primary
Measure Title Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.
Measure 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.  
[units: subjects]
  26     28  

No statistical analysis provided for Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.



2.  Secondary:   Number of Subjects Reporting Any Unsolicited Symptoms.   [ Time Frame: Within 30 days after each dose ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any Unsolicited Symptoms.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Total Vaccinated Cohort

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
Number of Subjects Reporting Any Unsolicited Symptoms.  
[units: subjects]
  47     48  

No statistical analysis provided for Number of Subjects Reporting Any Unsolicited Symptoms.



3.  Secondary:   Number of Subjects Reporting Any Serious Adverse Events.   [ 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). ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any Serious Adverse Events.
Measure 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).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Total Vaccinated Cohort

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
Number of Subjects Reporting Any Serious Adverse Events.  
[units: subjects]
  17     12  

No statistical analysis provided for Number of Subjects Reporting Any Serious Adverse Events.



4.  Secondary:   Number of Subjects Reporting Each Type of Solicited Symptom.   [ Time Frame: Within the 15-day solicited follow-up period after each dose ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Each Type of Solicited Symptom.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
Number of Subjects Reporting Each Type of Solicited Symptom.  
[units: subjects]
   
Cough     35     31  
Diarrhea     16     16  
Fever     30     28  
Irritability     31     28  
Loss of appetite     23     23  
Vomiting     19     15  

No statistical analysis provided for Number of Subjects Reporting Each Type of Solicited Symptom.



5.  Secondary:   The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.   [ Time Frame: At the screening visit and 2 months after dose 3 (Visit 4). ]

Measure Type Secondary
Measure Title The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.
Measure 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).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.  
[units: subjects]
   
Severe suppression at screening (n= 50, 50)     1     2  
Moderate suppression at screening (n= 50, 50)     12     15  
No suppression at screening (n= 50, 50)     37     33  
Severe suppression at Visit 4 (n= 43, 39)     11     7  
Moderate suppression at Visit 4 (n= 43, 39)     15     18  
No suppression at Visit 4 (n= 43, 39)     13     10  
Unknown at Visit 4 (n= 43, 39)     4     4  

No statistical analysis provided for The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.



6.  Secondary:   Human Immunodeficiency Virus (HIV) Viral Load   [ Time Frame: At the screening visit and 2 months after dose 3. ]

Measure Type Secondary
Measure Title Human Immunodeficiency Virus (HIV) Viral Load
Measure 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
Human Immunodeficiency Virus (HIV) Viral Load  
[units: base-10 logarithm of copies/milliliter]
Mean ± Standard Deviation
   
At screening (n= 50, 50)     5.7  ± 0.52     5.7  ± 0.51  
Two months after dose 3 (n= 43, 36)     5.6  ± 0.77     5.7  ± 0.51  

No statistical analysis provided for Human Immunodeficiency Virus (HIV) Viral Load



7.  Secondary:   Number of Subjects Who Seroconverted Against Rotavirus   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects Who Seroconverted Against Rotavirus
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  21     22  
Number of Subjects Who Seroconverted Against Rotavirus  
[units: subjects]
  12     4  

No statistical analysis provided for Number of Subjects Who Seroconverted Against Rotavirus



8.  Secondary:   Number of Subjects With Vaccine Take.   [ Time Frame: Two months after the dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects With Vaccine Take.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  23     22  
Number of Subjects With Vaccine Take.  
[units: subjects]
  15     7  

No statistical analysis provided for Number of Subjects With Vaccine Take.



9.  Secondary:   Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.
Measure Description Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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.


Reporting Groups
  Description
Rotarix Group No text entered.

Measured Values
    Rotarix Group  
Number of Participants Analyzed  
[units: participants]
  21  
Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.  
[units: Units/milliliter]
Geometric Mean ( 95% Confidence Interval )
  75.5  
  ( 29.1 to 195.7 )  

No statistical analysis provided for Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.



10.  Secondary:   Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According To Protocol Cohort for immunogenicity

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     24  
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.  
[units: subjects]
   
≥ 0.15 µg/mL     20     23  
≥ 1 µg/mL     20     22  

No statistical analysis provided for Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.



11.  Secondary:   Geometric Mean Concentration for Anti-PRP Antibodies.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Geometric Mean Concentration for Anti-PRP Antibodies.
Measure Description No text entered.
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According to Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     24  
Geometric Mean Concentration for Anti-PRP Antibodies.  
[units: microgram/milliliter]
Geometric Mean ( 95% Confidence Interval )
  4.641  
  ( 1.764 to 12.215 )  
  4.865  
  ( 2.322 to 10.192 )  

No statistical analysis provided for Geometric Mean Concentration for Anti-PRP Antibodies.



12.  Secondary:   Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value
Measure Description The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL)
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According To Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     25  
Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value  
[units: subjects]
   
Anti-diphtheria     19     19  
Anti-tetanus     23     24  

No statistical analysis provided for Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value



13.  Secondary:   Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.
Measure Description No text entered.
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According to Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     25  
Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.  
[units: International Units / milliliter]
Geometric Mean ( 95% Confidence Interval )
   
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 )  

No statistical analysis provided for Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.



14.  Secondary:   Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value
Measure Description The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According To Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  23     20  
Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value  
[units: subjects]
  15     11  

No statistical analysis provided for Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value



15.  Secondary:   Geometric Mean Concentration for Anti-HBs Antibodies.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Geometric Mean Concentration for Anti-HBs Antibodies.
Measure Description No text entered.
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According to Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  23     20  
Geometric Mean Concentration for Anti-HBs Antibodies.  
[units: Milli International Units/milliliter]
Geometric Mean ( 95% Confidence Interval )
  25.6  
  ( 14.3 to 45.8 )  
  18.9  
  ( 9.9 to 36.1 )  

No statistical analysis provided for Geometric Mean Concentration for Anti-HBs Antibodies.



16.  Secondary:   Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value
Measure Description The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter(EL.U/mL).
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According To Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     24  
Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value  
[units: subjects]
  19     14  

No statistical analysis provided for Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value



17.  Secondary:   Geometric Mean Concentration for Anti-BPT Antibodies.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Geometric Mean Concentration for Anti-BPT Antibodies.
Measure Description No text entered.
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According to Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     24  
Geometric Mean Concentration for Anti-BPT Antibodies.  
[units: ELISA-Units/milliliter]
Geometric Mean ( 95% Confidence Interval )
  28.8  
  ( 19.3 to 42.8 )  
  18.1  
  ( 12.8 to 25.6 )  

No statistical analysis provided for Geometric Mean Concentration for Anti-BPT Antibodies.



18.  Secondary:   Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According To Protocol cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     24  
Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value  
[units: subjects]
   
Anti-polio type 1 (n= 25, 24)     19     15  
Anti-polio type 2 (n= 25, 24)     23     21  
Anti-polio type 3 (n= 25, 23)     18     15  

No statistical analysis provided for Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value



19.  Secondary:   Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.   [ Time Frame: Two months after dose 3 ]

Measure Type Secondary
Measure Title Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.
Measure Description No text entered.
Time Frame Two months after dose 3  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According To Protocol cohort for immunogenicity

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     24  
Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.  
[units: titer]
Geometric Mean ( 95% Confidence Interval )
   
Anti-polio 1 (n= 25, 24)     90.5  
  ( 36.4 to 225.3 )  
  53.0  
  ( 19.4 to 144.5 )  
Anti-polio 2 (n= 25, 24)     142.6  
  ( 60.8 to 334.2 )  
  252.4  
  ( 91.2 to 698.7 )  
Anti-polio 3 (n= 25, 23)     44.7  
  ( 19.2 to 104.2 )  
  66.0  
  ( 22.6 to 192.2 )  

No statistical analysis provided for Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.



20.  Secondary:   Rotavirus Antigen Excretion in Stool Samples   [ 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 ]

Measure Type Secondary
Measure Title Rotavirus Antigen Excretion in Stool Samples
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the According to Protocol Cohort for immunogenicity.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  25     25  
Rotavirus Antigen Excretion in Stool Samples  
[units: subjects]
  11     5  

No statistical analysis provided for Rotavirus Antigen Excretion in Stool Samples



21.  Secondary:   Rotavirus in Diarrheal Stool Samples   [ Time Frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding ]

Measure Type Secondary
Measure Title Rotavirus in Diarrheal Stool Samples
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Total Vaccinated Cohort

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  50     50  
Rotavirus in Diarrheal Stool Samples  
[units: Number of episodes]
  4     4  

No statistical analysis provided for Rotavirus in Diarrheal Stool Samples



22.  Secondary:   Enteric Pathogens Identification.   [ Time Frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding ]

Measure Type Secondary
Measure Title Enteric Pathogens Identification.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
  29     34  
Enteric Pathogens Identification.  
[units: 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  

No statistical analysis provided for Enteric Pathogens Identification.



23.  Secondary:   Rotavirus Vaccine Strain Identification if Applicable.   [ Time Frame: From dose 1 until 2 months after dose 3 or until end of RV shedding ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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