Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289185
First received: February 8, 2006
Last updated: July 3, 2014
Last verified: July 2014
Results First Received: November 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Malaria
Interventions: Biological: RTS,S/AS02D
Biological: Engerix-B®
Biological: TETRActHib™

  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
A total of 340 subjects were enrolled for this study. The study comprised 2 phases, a double-blind phase, from Week 0 to Month 9 (2 months after the administration of the last vaccine dose), followed by a single-blind safety phase, from Month 9 to study end at Month 20.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Engerix-B Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
RTS,S/AS02D Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

Participant Flow:   Overall Study
    Engerix-B Group     RTS,S/AS02D Group  
STARTED     170     170  
COMPLETED     142     144  
NOT COMPLETED     28     26  
Withdrawal by Subject                 4                 8  
Lost to Follow-up                 23                 17  
Death                 1                 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
Engerix-B Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
RTS,S/AS02D Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Total Total of all reporting groups

Baseline Measures
    Engerix-B Group     RTS,S/AS02D Group     Total  
Number of Participants  
[units: participants]
  170     170     340  
Age  
[units: Weeks]
Mean ± Standard Deviation
  7.87  ± 0.83     7.82  ± 0.77     7.85  ± 0.80  
Gender  
[units: Participants]
     
Female     85     91     176  
Male     85     79     164  



  Outcome Measures
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1.  Primary:   Concentrations of Antibodies Against Hepatitis B (Anti-HB)   [ Time Frame: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. ]

2.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Week 0 to Month 9. ]

3.  Primary:   Concentrations of Antibodies Against Diphtheria (Anti-D)   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

4.  Primary:   Concentrations of Antibodies Against Tetanus (Anti-T)   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

5.  Primary:   Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

6.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Month 9 to Month 20. ]

7.  Primary:   Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

8.  Primary:   Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value   [ Time Frame: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. ]

9.  Primary:   Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

10.  Primary:   Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

11.  Primary:   Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

12.  Primary:   Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value   [ Time Frame: Prior to vaccination at Week 0 (PRE), and at Month 3. ]

13.  Secondary:   Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies   [ Time Frame: Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9. ]

14.  Secondary:   Number of Subjects With Solicited Local Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine. ]

15.  Secondary:   Number of Subjects With Solicited Local Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine. ]

16.  Secondary:   Number of Subjects With Solicited General Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination ]

17.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs).   [ Time Frame: Within 30 days (Days 0–29) after vaccination ]

18.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Throughout the entire study, from Week 0 to Month 20. ]

19.  Secondary:   Time to First Malaria Infection   [ Time Frame: Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9). ]

20.  Secondary:   Number of Subjects Prevalent for Parasitemia   [ Time Frame: At Month 9 ]

21.  Secondary:   Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia   [ Time Frame: At Month 9 ]


  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:
Abdulla S et al. (2008) Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med. 359(24):2533-2544.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289185     History of Changes
Other Study ID Numbers: 104298
Study First Received: February 8, 2006
Results First Received: November 8, 2012
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration