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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263666
First Posted: December 9, 2005
Last Update Posted: January 9, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: February 13, 2009  
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

  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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      28  56.0%      25  50.0%      53  53.0% 
Male      22  44.0%      25  50.0%      47  47.0% 


  Outcome Measures
  Show All Outcome Measures

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. ]

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

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). ]

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

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). ]

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

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

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

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

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 ]

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

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 ]

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

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 ]

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

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 ]

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

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 ]

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

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 ]

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

22.  Secondary:   Rotavirus Vaccine Strain Identification.   [ Time Frame: From dose 1 until 2 months after dose 3 or until end of RV shedding ]

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

24.  Secondary:   Number of Subjects With the RV in Stool Samples   [ Time Frame: From Dose 1 until post Dose 3 ]


  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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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00263666     History of Changes
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: January 9, 2017