MalariaPhase 2NCT00436007
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
A Phase 2 study testing GSK 257049, Tritanrix™ HepB/Hib and Rouvax™ in people with Malaria, run by GlaxoSmithKline at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GSK 257049, Tritanrix™ HepB/Hib and Rouvax™
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 30 Apr 2007to 7 Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- GSK 257049, Tritanrix™ HepB/Hib, Rouvax™, Stamaril™, Polio Sabin™
- Keywords
- Africa, Plasmodium falciparum, Malaria
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK 257049Biological
GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine
Tritanrix™ HepB/HibBiological
Also called DTPwHepB/Hib vaccine
GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)
Rouvax™Biological
Aventis Pasteur's attenuated measles vaccine.
Stamaril™Biological
Also called Yellow Fever Vaccine
Aventis Pasteur's attenuated yellow fever vaccine.
Polio Sabin™Biological
Also called Oral Polio vaccine (OPV).
GSK Biologicals' oral polio virus vaccine
| Study group | Role | What they receive |
|---|---|---|
| GSK 257049 1 Group | Experimental | 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. Receives: Biological: GSK 257049; Biological: Tritanrix™ HepB/Hib; Biological: Rouvax™; Biological: Stamaril™; Biological: Polio Sabin™ |
| GSK 257049 2 Group | Experimental | 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. Receives: Biological: GSK 257049; Biological: Tritanrix™ HepB/Hib; Biological: Rouvax™; Biological: Stamaril™; Biological: Polio Sabin™ |
| Tritanrix™ HepB/Hiberix™ Group | Active comparator | 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. Receives: Biological: Tritanrix™ HepB/Hib; Biological: Rouvax™; Biological: Stamaril™; Biological: Polio Sabin™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Month 0 to Month 8
Secondary outcomes (17)
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.
Measured: At Months 0, 1, 3 and 7.
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 2 Group.
Measured: At Months 0, 3, 7 and 8.
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 Tritanrix™ HepB/Hiberix™ Group.
Measured: At Months 0, 3, 7 and 8.
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.
Measured: At Month 3
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.
Measured: From Month 8 to Month 19
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.
Measured: At Month 3
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.
Measured: At Month 3
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.
Measured: At Month 3
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.
Measured: At Months 7 and 8.
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.
Measured: At Months 7 and 8.
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.
Measured: At Months 0, 1, 3 and 7.
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.
Measured: At Months 0, 3, 7 and 8.
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.
Measured: At Months 0, 3, 7 and 8.
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.
Measured: During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.
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.
Measured: During the 7-day (Days 0-6) follow-up period after any vaccination
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.
Measured: During the 30-day (Days 0-29) follow-up period after any vaccination
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.
Measured: From Month 0 to Month 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study start30 Apr 2007
- Primary completion15 Sep 2008
- Study completion7 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436007
- Sponsor's protocol ID
- 106369
- Status last verified
- Apr 2017
- First submitted
- 15 Feb 2007
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 25885325Warimwe 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.
PubMed 23962071Asante 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.
PubMed 21782519Agnandji 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.
PubMed 20735271
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00436007
- Acronym / sponsor ID
- 106369
- Conditions
- Malaria
- Keywords
- Africa, Plasmodium falciparum, Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2007
- Primary completion
- 15 Sep 2008 (actual)
- Study completion
- 7 Oct 2009 (actual)
- First posted
- 16 Feb 2007 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK 257049 1 Group | Experimental | Biological: GSK 257049, Biological: Tritanrix™ HepB/Hib, Biological: Rouvax™, Biological: Stamaril™, Biological: Polio Sabin™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 | Experimental | Biological: GSK 257049, Biological: Tritanrix™ HepB/Hib, Biological: Rouvax™, Biological: Stamaril™, Biological: Polio Sabin™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 | Active comparator | Biological: Tritanrix™ HepB/Hib, Biological: Rouvax™, Biological: Stamaril™, Biological: Polio Sabin™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. |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK 257049GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine | Biological | GSK 257049 1 Group, GSK 257049 2 Group |
| Tritanrix™ HepB/HibAlso: DTPwHepB/Hib vaccineGSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™) | Biological | GSK 257049 1 Group, GSK 257049 2 Group, Tritanrix™ HepB/Hiberix™ Group |
| Rouvax™Aventis Pasteur's attenuated measles vaccine. | Biological | GSK 257049 1 Group, GSK 257049 2 Group, Tritanrix™ HepB/Hiberix™ Group |
| Stamaril™Also: Yellow Fever VaccineAventis Pasteur's attenuated yellow fever vaccine. | Biological | GSK 257049 1 Group, GSK 257049 2 Group, Tritanrix™ HepB/Hiberix™ Group |
| Polio Sabin™Also: Oral Polio vaccine (OPV).GSK Biologicals' oral polio virus vaccine | Biological | GSK 257049 1 Group, GSK 257049 2 Group, Tritanrix™ HepB/Hiberix™ Group |
Primary outcome
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Month 0 to Month 8
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
17 secondary outcomes
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Time frame: At Months 0, 1, 3 and 7.
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Time frame: At Months 0, 3, 7 and 8.
Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Time frame: At Months 0, 3, 7 and 8.
Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Month 3
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Month 8 to Month 19
Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.
Time frame: At Month 3
Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).
Time frame: At Month 3
Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.
Time frame: At Month 3
Concentrations of Anti-measles Antibodies.
Time frame: At Months 7 and 8.
Titers for Anti-yellow Fever Antibodies.
Time frame: At Months 7 and 8.
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Time frame: At Months 0, 1, 3 and 7.
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Time frame: At Months 0, 3, 7 and 8.
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Time frame: At Months 0, 3, 7 and 8.
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.
Number of Subjects With Solicited General Symptoms.
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0-29) follow-up period after any vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Month 0 to Month 19
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25885325Ajua 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.
- Derived from this study: PubMed 23962071Warimwe 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.
- Derived from this study: PubMed 21782519Asante 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.
- Derived from this study: PubMed 20735271Agnandji 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK 257049, Tritanrix™ HepB/Hib and Rouvax™ in people with Malaria, run by GlaxoSmithKline at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Gabon, Ghana, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Serious Adverse Events (SAEs). (time frame: From Month 0 to Month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00436007, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.