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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GSK 257049

Tritanrix™ HepB/Hib

Rouvax™

Stamaril™

Polio Sabin™

About this trial

This is an interventional prevention trial for Malaria focused on measuring Africa, Plasmodium falciparum, Malaria

Eligibility Criteria

6 Weeks - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
Subjects who have received one previous dose of OPV and BCG.
Subjects who are born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

Acute disease at the time of enrolment.
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Laboratory screening tests out of range, specifically: ALT and creatinine above acceptable limit; Hemoglobin, Platelet count and Total white cell count below acceptable limit.
Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
BCG administration within one week of proposed administration of a study vaccine.
OPV administration within four weeks of proposed administration of a study vaccine.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Simultaneous participation in any other clinical trial.
Twins (to avoid misidentification).
Maternal death.
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

GSK 257049 1 Group

GSK 257049 2 Group

Tritanrix™ HepB/Hiberix™ Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Subjects With Serious Adverse Events (SAEs).

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Secondary Outcome Measures

Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).

Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.

Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).

Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.

Number of Subjects With Serious Adverse Events (SAEs).

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.

Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.

Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).

Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.

Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.

Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.

Concentrations of Anti-measles Antibodies.

Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.

Titers for Anti-yellow Fever Antibodies.

Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.

Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.

Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.

Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.

Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.

Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.

Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.

Number of Subjects With Solicited Local Symptoms.

Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.

Number of Subjects With Solicited General Symptoms.

Assessed solicited general symptoms were drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.

Number of Subjects With Unsolicited Adverse Events (AEs)

An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.

Number of Subjects With Serious Adverse Events (SAEs).

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Full Information

NCT ID

NCT00436007

First Posted

February 15, 2007

Last Updated

July 19, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00436007

Brief Title

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

Official Title

Safety and Immunogenicity Study of GSK Biologicals' Investigational Vaccination Regimen Malaria Vaccine 257049, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes Tritanrix HepB/Hib, OPV, Measles and Yellow Fever Vaccination in Infants

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

April 30, 2007 (undefined)

Primary Completion Date

September 15, 2008 (Actual)

Study Completion Date

October 7, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Two vaccination schedules will be studied, which constitutes the two alternative three dose regimens for the malaria candidate vaccine 257049 integration into EPI. The co-administered EPI vaccines include GSK Biologicals' Tritanrix™-HepB/Hiberix™, a measles vaccine (depending on the supply availability), Aventis Pasteur's Yellow Fever vaccine Stamaril™ and GSK Biologicals' Oral Polio vaccine Polio Sabin™. Tuberculosis vaccine (Bacillus of Calmette and Guerin, BCG) will be administered according to national medical practice and will not be administered as part of this protocol, but will be documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Africa, Plasmodium falciparum, Malaria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

511 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK 257049 1 Group

Arm Type

Experimental

Arm Description

Arm Title

GSK 257049 2 Group

Arm Type

Experimental

Arm Description

Arm Title

Tritanrix™ HepB/Hiberix™ Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK 257049

Intervention Description

GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine

Intervention Type

Biological

Intervention Name(s)

Tritanrix™ HepB/Hib

Other Intervention Name(s)

DTPwHepB/Hib vaccine

Intervention Description

GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)

Intervention Type

Biological

Intervention Name(s)

Rouvax™

Intervention Description

Aventis Pasteur's attenuated measles vaccine.

Intervention Type

Biological

Intervention Name(s)

Stamaril™

Other Intervention Name(s)

Yellow Fever Vaccine

Intervention Description

Aventis Pasteur's attenuated yellow fever vaccine.

Intervention Type

Biological

Intervention Name(s)

Polio Sabin™

Other Intervention Name(s)

Oral Polio vaccine (OPV).

Intervention Description

GSK Biologicals' oral polio virus vaccine

Primary Outcome Measure Information:

Title

Number of Subjects With Serious Adverse Events (SAEs).

Description

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Time Frame

From Month 0 to Month 8

Secondary Outcome Measure Information:

Title

Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).

Description

Time Frame

At Months 0, 1, 3 and 7.

Title

Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).

Description

Time Frame

At Months 0, 3, 7 and 8.

Title

Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).

Description

Time Frame

At Months 0, 3, 7 and 8.

Title

Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Description

Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.

Time Frame

At Month 3

Title

Number of Subjects With Serious Adverse Events (SAEs).

Description

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Time Frame

From Month 8 to Month 19

Title

Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.

Description

Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.

Time Frame

At Month 3

Title

Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).

Description

Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.

Time Frame

At Month 3

Title

Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.

Description

Time Frame

At Month 3

Title

Concentrations of Anti-measles Antibodies.

Description

Time Frame

At Months 7 and 8.

Title

Titers for Anti-yellow Fever Antibodies.

Description

Time Frame

At Months 7 and 8.

Title

Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.

Description

Time Frame

At Months 0, 1, 3 and 7.

Title

Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.

Description

Time Frame

At Months 0, 3, 7 and 8.

Title

Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.

Description

Time Frame

At Months 0, 3, 7 and 8.

Title

Number of Subjects With Solicited Local Symptoms.

Description

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.

Title

Number of Subjects With Solicited General Symptoms.

Description

Time Frame

During the 7-day (Days 0-6) follow-up period after any vaccination

Title

Number of Subjects With Unsolicited Adverse Events (AEs)

Description

Time Frame

During the 30-day (Days 0-29) follow-up period after any vaccination

Title

Number of Subjects With Serious Adverse Events (SAEs).

Description

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Time Frame

From Month 0 to Month 19

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

10 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A male or female infant between 6 and 10 weeks of age at the time of first vaccination. Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. Subjects who have received one previous dose of OPV and BCG. Subjects who are born after a normal gestation period (between 36 and 42 weeks). Exclusion Criteria: Acute disease at the time of enrolment. Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. Laboratory screening tests out of range, specifically: ALT and creatinine above acceptable limit; Hemoglobin, Platelet count and Total white cell count below acceptable limit. Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines. BCG administration within one week of proposed administration of a study vaccine. OPV administration within four weeks of proposed administration of a study vaccine. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Simultaneous participation in any other clinical trial. Twins (to avoid misidentification). Maternal death. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Lambaréné

Country

Gabon

Facility Name

GSK Investigational Site

City

Kintampo

Country

Ghana

Facility Name

GSK Investigational Site

City

Dar-es-Salaam

Country

Tanzania

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

25885325

Citation

Ajua A, Lell B, Agnandji ST, Asante KP, Owusu-Agyei S, Mwangoka G, Mpina M, Salim N, Tanner M, Abdulla S, Vekemans J, Jongert E, Lievens M, Cambron P, Ockenhouse CF, Kremsner PG, Mordmuller B. The effect of immunization schedule with the malaria vaccine candidate RTS,S/AS01E on protective efficacy and anti-circumsporozoite protein antibody avidity in African infants. Malar J. 2015 Feb 13;14:72. doi: 10.1186/s12936-015-0605-7.

Results Reference

derived

PubMed Identifier

23962071

Citation

Warimwe GM, Fletcher HA, Olotu A, Agnandji ST, Hill AV, Marsh K, Bejon P. Peripheral blood monocyte-to-lymphocyte ratio at study enrollment predicts efficacy of the RTS,S malaria vaccine: analysis of pooled phase II clinical trial data. BMC Med. 2013 Aug 21;11:184. doi: 10.1186/1741-7015-11-184.

Results Reference

derived

PubMed Identifier

21782519

Citation

Asante KP, Abdulla S, Agnandji S, Lyimo J, Vekemans J, Soulanoudjingar S, Owusu R, Shomari M, Leach A, Jongert E, Salim N, Fernandes JF, Dosoo D, Chikawe M, Issifou S, Osei-Kwakye K, Lievens M, Paricek M, Moller T, Apanga S, Mwangoka G, Dubois MC, Madi T, Kwara E, Minja R, Hounkpatin AB, Boahen O, Kayan K, Adjei G, Chandramohan D, Carter T, Vansadia P, Sillman M, Savarese B, Loucq C, Lapierre D, Greenwood B, Cohen J, Kremsner P, Owusu-Agyei S, Tanner M, Lell B. Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. Lancet Infect Dis. 2011 Oct;11(10):741-9. doi: 10.1016/S1473-3099(11)70100-1. Epub 2011 Jul 22. Erratum In: Lancet Infect Dis. 2011 Oct;11(10):727.

Results Reference

derived

PubMed Identifier

20735271

Citation

Agnandji ST, Asante KP, Lyimo J, Vekemans J, Soulanoudjingar SS, Owusu R, Shomari M, Leach A, Fernandes J, Dosoo D, Chikawe M, Issifou S, Osei-Kwakye K, Lievens M, Paricek M, Apanga S, Mwangoka G, Okissi B, Kwara E, Minja R, Lange J, Boahen O, Kayan K, Adjei G, Chandramohan D, Jongert E, Demoitie MA, Dubois MC, Carter T, Vansadia P, Villafana T, Sillman M, Savarese B, Lapierre D, Ballou WR, Greenwood B, Tanner M, Cohen J, Kremsner PG, Lell B, Owusu-Agyei S, Abdulla S. Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. J Infect Dis. 2010 Oct 1;202(7):1076-87. doi: 10.1086/656190. Erratum In: J Infect Dis. 2011 May 1;203(9):1344.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106369

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106369

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106369

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106369

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106369

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106369

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

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

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