Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00436007
First received: February 15, 2007
Last updated: May 23, 2013
Last verified: May 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Malaria Vaccines
Interventions: Biological: GSK 257049
Biological: Tritanrix™ HepB/Hib
Biological: Rouvax™
Biological: Stamaril™
Biological: Polio Sabin™

  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
The study comprised a vaccination phase (Months 0-8) and a follow-up phase (Months 8-19). The Stamaril™ vaccine was not part of the EPI Tanzanian vaccination schedule at study planning. Hence this vaccine was not administered to subjects from Tanzania.

Reporting Groups
  Description
GSK 257049 1 Group

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

GSK 257049 2 Group Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Tritanrix™ HepB/Hiberix™ Group Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Participant Flow:   Overall Study
    GSK 257049 1 Group     GSK 257049 2 Group     Tritanrix™ HepB/Hiberix™ Group  
STARTED     170     170     171  
COMPLETED     151     156     148  
NOT COMPLETED     19     14     23  
Withdrawal by Subject                 5                 3                 4  
Lost to Follow-up                 14                 10                 13  
Physician Decision                 0                 0                 2  
Death                 0                 1                 3  
Unspecified                 0                 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
GSK 257049 1 Group

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

GSK 257049 2 Group Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Tritanrix™ HepB/Hiberix™ Group Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Total Total of all reporting groups

Baseline Measures
    GSK 257049 1 Group     GSK 257049 2 Group     Tritanrix™ HepB/Hiberix™ Group     Total  
Number of Participants  
[units: participants]
  170     170     171     511  
Age  
[units: Weeks]
Mean ± Standard Deviation
  7.0  ± 0.97     7.1  ± 1.05     7.0  ± 0.97     7.0  ± 1.00  
Gender  
[units: Subjects]
       
Female     90     84     78     252  
Male     80     86     93     259  
Region of Enrollment  
[units: Subjects]
       
Gabon     73     73     74     220  
Ghana     27     27     27     81  
Tanzania     70     70     70     210  



  Outcome Measures
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1.  Primary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: From Month 0 to Month 8 ]

2.  Secondary:   Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).   [ Time Frame: At Months 0, 1, 3 and 7. ]

3.  Secondary:   Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).   [ Time Frame: At Months 0, 3, 7 and 8. ]

4.  Secondary:   Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).   [ Time Frame: At Months 0, 3, 7 and 8. ]

5.  Secondary:   Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.   [ Time Frame: At Month 3 ]

6.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: From Month 8 to Month 19 ]

7.  Secondary:   Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.   [ Time Frame: At Month 3 ]

8.  Secondary:   Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).   [ Time Frame: At Month 3 ]

9.  Secondary:   Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.   [ Time Frame: At Month 3 ]

10.  Secondary:   Concentrations of Anti-measles Antibodies.   [ Time Frame: At Months 7 and 8. ]

11.  Secondary:   Titers for Anti-yellow Fever Antibodies.   [ Time Frame: At Months 7 and 8. ]

12.  Secondary:   Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.   [ Time Frame: At Months 0, 1, 3 and 7. ]

13.  Secondary:   Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.   [ Time Frame: At Months 0, 3, 7 and 8. ]

14.  Secondary:   Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.   [ Time Frame: At Months 0, 3, 7 and 8. ]

15.  Secondary:   Number of Subjects With Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. ]

16.  Secondary:   Number of Subjects With Solicited General Symptoms.   [ Time Frame: During the 7-day (Days 0-6) follow-up period after any vaccination ]

17.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 30-day (Days 0-29) follow-up period after any vaccination ]

18.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: From Month 0 to Month 19 ]


  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:
Owusu Agyei S et al. Randomized, controlled phase 2 study assessing the safety and immunogenicity of the RTS,S/AS01E candidate malaria vaccine, when incorporated into an EPI regimen including DTPwHepB/Hib, OPV, measles and yellow fever vaccination. Abstract presented at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference (MIM). Nairobi, Kenya, 2-6 November 2009.
Owusu Agyei S et al. Safety and efficacy the RTS,S/AS01E malaria vaccine: extended follow up of a randomized controlled Phase 2 trial. Abstract presented at the 59th Annual Meeting on American Society of Tropical Medicine and Hygiene (ASTMH). Philadelphia, USA, 4-8 November 2010.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00436007     History of Changes
Other Study ID Numbers: 106369
Study First Received: February 15, 2007
Results First Received: December 19, 2012
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration