MalariaPhase 2NCT01231503
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
A Phase 2 study testing GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B and Tritanrix HepB Hib in people with Malaria, run by GlaxoSmithKline at 1 site in Malawi.
Trial summary
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B and Tritanrix HepB Hib
- 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
- 480 participants
- Where
- 1 siteMalawi
- Study dates
- 13 Jan 2011to 23 Dec 2014
- 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 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All subjects must satisfy the following criteria at study entry:
- A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth).
- 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 the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- Born to a mother negative for HIV antibody and Hepatitis B surface antigen.
- Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life).
- A minimum weight of 2.5 kg.
Who cannot join
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to:
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects.
- History of any neurological disorders or seizures.
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- Laboratory screening tests out of normal ranges/limits defined per protocol.
- Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vaccines.
- Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) not foreseen by the study protocol within 7 days of the first dose of study vaccine.
- 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.
- Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) other than the study vaccine starting at birth or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Simultaneous participation in any other clinical trial.
- Same-sex 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.
- Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity
- 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
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine 257049 When Administered on Different Schedules to Infants in Africa
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:
- Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
- Investigate how to maximize the antibody response to the experimental malaria vaccine.
- Conditions
- Malaria
- Being tested
- GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B, Tritanrix HepB Hib, BCG, OPV
- Keywords
- Africa, malaria vaccine, schedule, EPI, Plasmodium falciparum
- 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 Biological's Investigational Malaria Vaccine 257049Biological
Also called GSK257049, RTS, S/AS01E
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Engerix-BBiological
Also called HBV
1 dose, intramuscular route: left antero-lateral thigh at birth (=< 7 days of age)
Tritanrix HepB HibBiological
Also called DTPwHepB/Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCGBiological
Also called Bacille Calmette Guerin tuberculosis vaccine
1 dose, intradermal route, in shoulder at birth (=< 7 days of age)
OPVBiological
Also called Polio Sabin
4 doses, orally, at birth (=< 7 days of age) and at 6, 10 and 14 weeks of age
RouvaxBiological
Also called Measles, measles vaccine
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
| Study group | Role | What they receive |
|---|---|---|
| RTS,S Neo-10-14 Group | Experimental | Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| RTS,S Neo-10-26 Group | Experimental | Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanri xHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| RTS,S 6-10-14 Group | Experimental | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| RTS,S 6-10-26 Group | Experimental | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| Engerix-B Neo/RTS,S 6-10-26 Group | Experimental | Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Engerix-B; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| RTS,S 10-14-26 Group | Experimental | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| RTS,S 14-26-9M Group | Experimental | Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: GSK Biological's Investigational Malaria Vaccine 257049; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
| Engerix-B Neo Group | Active comparator | Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. Receives: Biological: Engerix-B; Biological: Tritanrix HepB Hib; Biological: BCG; Biological: OPV; Biological: Rouvax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reported With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Measured: From study start at Month 0 up to Month 10.
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Measured: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Measured: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Measured: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M10 for RTS,S 14-26-9M Group
Secondary outcomes (26)
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group.
Measured: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group
Number of Subjects Reported With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Measured: From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal ALT level was defined as ALT< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as > 10.0 times the ULN.
Measured: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.
Measured: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G 2, G 3, G 4 or Missing. Normal HAE level was defined as HAE > 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE < 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE < 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE < 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE < 7.0 g/dL.
Measured: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G2, G3, G4 or Missing. Normal PLA level was defined as > 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as < 25 Billions PLA/L.
Measured: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal WBC level was defined as > 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as < 1.0 Billions WBC/L.
Measured: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was greater than or equal to (≥) 0.5 EL.U/mL.
Measured: At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-off values for the assay were greater than or equal to (≥) 6.2 and 10 mIU/mL, respectively.
Measured: At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off value for the assay was ≥ 0.1 IU/mL.
Measured: At Month 5
Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations
Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off value for the assay was ≥ 0.15 µg/mL.
Measured: At Month 5
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations
Anti-Polio 1, 2 and 3 antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in international units per mililiter (IU/mL) and tabulated. The seroprotection cut-off value for the assay was ≥ 8 IU/mL.
Measured: At Month 5
Concentrations of Antibodies Against Acellular B-pertussis (BPT)
Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was ≥ 15 EL.U/mL.
Measured: At Month 5
Concentrations of Antibodies Against Measles Antigens
Concentrations of anti measles antibodies were determined by ELISA and expressed as GMCs in milli-international units per millilitre (mIU/mL).
The seropositivity cut-off value for the assay was ≥ 150 mIU/mL. Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups.
Measured: At Month 10
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Measured: Within 7 days (Days 0-6) after Week 0 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Measured: Within 7 days (Days 0-6) after Week 6 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Measured: Within 7 days (Days 0-6) after Week 10 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Measured: Within 7 days (Days 0-6) after Week 14 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive vaccination at this time point.
Measured: Within 7 days (Days 0-6) after Week 26 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Measured: Within 7 days (Days 0-6) after Month 9 vaccination
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Measured: Within 7 days (Days 0-6) after Week 0 vaccination
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Measured: Within 7 days (Days 0-6) after Week 6 vaccination
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Measured: Within 7 days (Days 0-6) after Week 10 vaccination
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Measured: Within 7 days (Days 0-6) after Week 14 vaccination
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive any vaccination at this time point
Measured: Within 7 days (Days 0-6) after Week 26 vaccination
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. "Any" about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Measured: Within 7 days (Days 0-6) after Month 9 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study start13 Jan 2011
- Primary completion30 Apr 2014
- Study completion23 Dec 2014
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 (1)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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231503
- Sponsor's protocol ID
- 111315
- Status last verified
- Jun 2018
- First submitted
- 14 Oct 2010
- Last updated
- 15 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Witte D, Cunliffe NA, Turner AM, Ngulube E, Ofori-Anyinam O, Vekemans J, Chimpeni P, Lievens M, Wilson TP, Njiram'madzi J, Mendoza YG, Leach A. Safety and Immunogenicity of Seven Dosing Regimens of the Candidate RTS,S/AS01E Malaria Vaccine Integrated Within an Expanded Program on Immunization Regimen: A Phase II, Single-Center, Open, Controlled Trial in Infants in Malawi. Pediatr Infect Dis J. 2018 May;37(5):483-491. doi: 10.1097/INF.0000000000001937.
PubMed 29432383
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine 257049 When Administered on Different Schedules to Infants in Africa
- ClinicalTrials.gov ID
- NCT01231503
- Acronym / sponsor ID
- 111315
- Conditions
- Malaria
- Keywords
- Africa, malaria vaccine, schedule, EPI, Plasmodium falciparum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Study start
- 13 Jan 2011 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 23 Dec 2014 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Posted 20 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:
- Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
- Investigate how to maximize the antibody response to the experimental malaria vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| RTS,S Neo-10-14 Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S Neo-10-26 Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanri xHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 6-10-14 Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 6-10-26 Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| Engerix-B Neo/RTS,S 6-10-26 Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Engerix-B, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 10-14-26 Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 14-26-9M Group | Experimental | Biological: GSK Biological's Investigational Malaria Vaccine 257049, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| Engerix-B Neo Group | Active comparator | Biological: Engerix-B, Biological: Tritanrix HepB Hib, Biological: BCG, Biological: OPV, Biological: RouvaxSubjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth).
- 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 the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
- Born to a mother negative for HIV antibody and Hepatitis B surface antigen.
- Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life).
Key exclusion criteria (19 listed)
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to:
- Laboratory screening tests out of normal ranges/limits defined per protocol.
- Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vaccines.
- Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO [with respect to prequalification]) not foreseen by the study protocol within 7 days of the first dose of 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 Biological's Investigational Malaria Vaccine 257049Also: GSK257049, RTS, S/AS01E3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age | Biological | Engerix-B Neo/RTS,S 6-10-26 Group, RTS,S 10-14-26 Group, RTS,S 14-26-9M Group, RTS,S 6-10-14 Group, RTS,S 6-10-26 Group, RTS,S Neo-10-14 Group, RTS,S Neo-10-26 Group |
| Engerix-BAlso: HBV1 dose, intramuscular route: left antero-lateral thigh at birth (=< 7 days of age) | Biological | Engerix-B Neo Group, Engerix-B Neo/RTS,S 6-10-26 Group |
| Tritanrix HepB HibAlso: DTPwHepB/Hib3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age | Biological | Engerix-B Neo Group, Engerix-B Neo/RTS,S 6-10-26 Group, RTS,S 10-14-26 Group, RTS,S 14-26-9M Group, RTS,S 6-10-14 Group, RTS,S 6-10-26 Group, RTS,S Neo-10-14 Group, RTS,S Neo-10-26 Group |
| BCGAlso: Bacille Calmette Guerin tuberculosis vaccine1 dose, intradermal route, in shoulder at birth (=< 7 days of age) | Biological | Engerix-B Neo Group, Engerix-B Neo/RTS,S 6-10-26 Group, RTS,S 10-14-26 Group, RTS,S 14-26-9M Group, RTS,S 6-10-14 Group, RTS,S 6-10-26 Group, RTS,S Neo-10-14 Group, RTS,S Neo-10-26 Group |
| OPVAlso: Polio Sabin4 doses, orally, at birth (=< 7 days of age) and at 6, 10 and 14 weeks of age | Biological | Engerix-B Neo Group, Engerix-B Neo/RTS,S 6-10-26 Group, RTS,S 10-14-26 Group, RTS,S 14-26-9M Group, RTS,S 6-10-14 Group, RTS,S 6-10-26 Group, RTS,S Neo-10-14 Group, RTS,S Neo-10-26 Group |
| RouvaxAlso: Measles, measles vaccine1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age | Biological | Engerix-B Neo Group, Engerix-B Neo/RTS,S 6-10-26 Group, RTS,S 10-14-26 Group, RTS,S 14-26-9M Group, RTS,S 6-10-14 Group, RTS,S 6-10-26 Group, RTS,S Neo-10-14 Group, RTS,S Neo-10-26 Group |
Primary outcome
Number of Subjects Reported With Serious Adverse Events (SAEs)
Time frame: From study start at Month 0 up to Month 10.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Time frame: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Time frame: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Time frame: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M10 for RTS,S 14-26-9M Group
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
26 secondary outcomes
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group
Number of Subjects Reported With Serious Adverse Events (SAEs)
Time frame: From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Time frame: At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
Time frame: At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Time frame: At Month 5
Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations
Time frame: At Month 5
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations
Time frame: At Month 5
Concentrations of Antibodies Against Acellular B-pertussis (BPT)
Time frame: At Month 5
Concentrations of Antibodies Against Measles Antigens
Time frame: At Month 10
Number of Subjects Reported With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after Week 0 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after Week 6 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after Week 10 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after Week 14 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after Week 26 vaccination
Number of Subjects Reported With Solicited Local Symptoms
Time frame: Within 7 days (Days 0-6) after Month 9 vaccination
Number of Subjects Reported With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after Week 0 vaccination
Number of Subjects Reported With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after Week 6 vaccination
Number of Subjects Reported With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after Week 10 vaccination
Number of Subjects Reported With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after Week 14 vaccination
Number of Subjects Reported With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after Week 26 vaccination
Number of Subjects Reported With Solicited General Symptoms
Time frame: Within 7 days (Days 0-6) after Month 9 vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29432383Witte D, Cunliffe NA, Turner AM, Ngulube E, Ofori-Anyinam O, Vekemans J, Chimpeni P, Lievens M, Wilson TP, Njiram'madzi J, Mendoza YG, Leach A. Safety and Immunogenicity of Seven Dosing Regimens of the Candidate RTS,S/AS01E Malaria Vaccine Integrated Within an Expanded Program on Immunization Regimen: A Phase II, Single-Center, Open, Controlled Trial in Infants in Malawi. Pediatr Infect Dis J. 2018 May;37(5):483-491. doi: 10.1097/INF.0000000000001937.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B and Tritanrix HepB Hib in people with Malaria, run by GlaxoSmithKline at 1 site in Malawi.
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 7 inclusion and 19 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 15 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 1 site in Malawi. 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 20 May 2015). 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 Reported With Serious Adverse Events (SAEs) (time frame: From study start at Month 0 up to Month 10.). The study lists 4 primary outcomes in all. 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 NCT01231503, which also lists 1 linked publication.
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 15 Aug 2018.