A Phase 2 interventional study of GSK 257049 and Tritanrix™ HepB/Hib in Malaria, sponsored by GlaxoSmithKline. Completed at 3 sites in 3 countries. Open to participants aged 6 Weeks to 10 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
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.
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 511 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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, 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.
Biological: Tritanrix™ HepB/Hib · Biological: Rouvax™ · Biological: Stamaril™ · Biological: Polio Sabin™
GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine
GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)
Also known as: DTPwHepB/Hib vaccine
Aventis Pasteur's attenuated measles vaccine.
Aventis Pasteur's attenuated yellow fever vaccine.
Also known as: Yellow Fever Vaccine
GSK Biologicals' oral polio virus vaccine
Also known as: Oral Polio vaccine (OPV).
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.
Time frame: From Month 0 to Month 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 GSK 257049 1 Group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From Month 0 to Month 19
| Milestone | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Started | 170 | 170 | 171 |
| Completed | 151 | 156 | 148 |
| Not completed | 19 | 14 | 23 |
| Withdrew: Withdrawal by subject | 5 | 3 | 4 |
| Withdrew: Lost to follow-up | 14 | 10 | 13 |
| Withdrew: Physician decision | 0 | 0 | 2 |
| Withdrew: Death | 0 | 1 | 3 |
| Withdrew: Other | 0 | 0 | 1 |
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
| subjects | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs). | 38 | 28 | 33 |
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.
| mIU/mL | GSK 257049 1 Group |
|---|---|
| Anti-HB, Month 0 [N=145] | 12.5 (9.9 to 15.7) |
| Anti-HB, Month 1 [N=133] | 173.4 (131.9 to 228.0) |
| Anti-HB, Month 3 [N=130] | 1355.7 (1100.6 to 1669.9) |
| Anti-HB, Month 7 [N=137] | 1555.5 (1315.8 to 1839.0) |
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.
| mIU/mL | GSK 257049 2 Group |
|---|---|
| Anti-HB, Month 0 [N=131] | 9.6 (7.8 to 11.8) |
| Anti-HB, Month 3 [N=119] | 651.2 (541.1 to 783.8) |
| Anti-HB, Month 7 [N=126] | 1133.1 (972.3 to 1320.6) |
| Anti-HB, Month 8 [N=125] | 59813.5 (47050.5 to 76038.6) |
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.
| mIU/mL | Tritanrix™ HepB/Hiberix™ Group |
|---|---|
| Anti-HB, Month 0 [N=143] | 8.7 (7.3 to 10.5) |
| Anti-HB, Month 3 [N=126] | 338.0 (266.3 to 429.0) |
| Anti-HB, Month 7 [N=131] | 159.9 (127.0 to 201.3) |
| Anti-HB, Month 8 [N=133] | 162.4 (127.9 to 206.3) |
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.
| IU/mL | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Anti-D | 1.0 (0.9 to 1.2) | 1.1 (0.9 to 1.3) | 1.4 (1.2 to 1.7) |
| Anti-T | 2.8 (2.3 to 3.3) | 2.6 (2.2 to 3.1) | 3.7 (3.2 to 4.3) |
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
| subjects | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs). | 28 | 24 | 27 |
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.
| µg/mL | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies. | 13.3 (10.5 to 16.7) | 15.7 (12.6 to 19.4) | 18.6 (14.8 to 23.5) |
Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.
| titers | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Anti-Polio 1 [N=136;125;131] | 463.6 (342.8 to 627.0) | 485.5 (342.5 to 688.3) | 500.0 (365.0 to 684.9) |
| Anti-Polio 2 [N=135;124;131] | 494.0 (389.7 to 626.2) | 563.2 (457.3 to 693.6) | 406.8 (329.1 to 502.9) |
| Anti-Polio 3 [N=135;125;133] | 123.5 (92.1 to 165.6) | 148.7 (112.2 to 197.0) | 205.1 (156.5 to 268.7) |
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.
| EL.U/mL | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies. | 85.3 (76.8 to 94.6) | 104.4 (94.8 to 115.0) | 106.5 (96.1 to 118.1) |
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.
| mIU/mL | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|
| Anti-measles, Month 7 [N=112;120] | 75.0 (75.0 to 75.0) | 1295.2 (1052.1 to 1594.5) |
| Anti-measles, Month 8 [N=119;122] | 76.2 (73.8 to 78.6) | 1299.0 (1038.8 to 1624.4) |
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.
| titers | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|
| Anti-yellow fever, Month 7 [N=41;62] | 5.3 (4.8 to 5.8) | 5.9 (5.1 to 6.9) |
| Anti-yellow fever, Month 8 [N=46;64] | 172.2 (135.9 to 236.3) | 183.4 (134.0 to 250.9) |
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.
| EL.U/mL | GSK 257049 1 Group |
|---|---|
| Anti-CS, Month 0 [N=153] | 0.4 (0.3 to 0.4) |
| Anti-CS, Month 2 [N=137] | 86.6 (66.5 to 112.7) |
| Anti-CS, Month 3 [N=131] | 190.3 (154.3 to 234.7) |
| Anti-CS, Month 7 [N=137] | 35.3 (28.5 to 43.8) |
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.
| EL.U/mL | GSK 257049 2 Group |
|---|---|
| Anti-CS, Month 0 [N=141] | 0.4 (0.3 to 0.4) |
| Anti-CS, Month 3 [N=121] | 57.7 (43.7 to 76.2) |
| Anti-CS, Month 7 [N=127] | 6.1 (4.6 to 7.9) |
| Anti-CS, Month 8 [N=127] | 107.8 (81.1 to 143.4) |
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.
| EL.U/mL | Tritanrix™ HepB/Hiberix™ Group |
|---|---|
| Anti-CS, Month 0 [N=156] | 0.4 (0.3 to 0.4) |
| Anti-CS, Month 3 [N=129] | 0.3 (0.3 to 0.3) |
| Anti-CS, Month 7 [N=132] | 0.3 (0.3 to 0.3) |
| Anti-CS, Month 8 [N=135] | 0.3 (0.3 to 0.3) |
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.
| subjects | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Pain - GSK 257049 [N=170;170;0] | 126 | 116 | NA |
| Swelling - GSK 257049 [N=170;170;0] | 28 | 44 | NA |
| Pain - Rouvax™ [N=163;161;159] | 52 | 54 | 47 |
| Swelling - Rouvax™ [N=163;161;159] | 20 | 21 | 16 |
| Pain - Stamaril™ [N=95;94;94] | 2 | 7 | 2 |
| Swelling - Stamaril™ [N=95;94;94] | 0 | 1 | 0 |
| Pain - Tritanrix™ HepB/Hib [N=170;170;171] | 127 | 133 | 140 |
| Swelling - Tritanrix™ HepB/Hib [N=170;170;171] | 47 | 68 | 68 |
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.
| subjects | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Drowsiness | 82 | 97 | 72 |
| Fever (axillary temperature ≥ 37.5°C) | 102 | 95 | 75 |
| Irritability | 124 | 131 | 118 |
| Loss of appetite | 68 | 83 | 70 |
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.
| subjects | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | 160 | 161 | 164 |
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
| subjects | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs). | 57 | 47 | 49 |
Collected over SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK 257049 1 Group | — | 57/170 (33.5%) | 169/170 (99.4%) |
| GSK 257049 2 Group | — | 47/170 (27.6%) | 169/170 (99.4%) |
| Tritanrix™ HepB/Hiberix™ Group | — | 49/171 (28.7%) | 171/171 (100%) |
| Event | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| GastroenteritisInfections and infestations | 17/170 | 10/170 | 14/171 |
| Plasmodium falciparum infectionInfections and infestations | 6/170 | 6/170 | 14/171 |
| Plasmodium falciparum infectionInfections and infestations | 5/170 | 10/170 | 13/171 |
| PneumoniaInfections and infestations | 11/170 | 9/170 | 8/171 |
| AnaemiaBlood and lymphatic system disorders | 6/170 | 10/170 | 10/171 |
| AnaemiaBlood and lymphatic system disorders | 6/170 | 6/170 | 10/171 |
| PneumoniaInfections and infestations | 5/170 | 7/170 | 7/171 |
| Upper respiratory tract infectionInfections and infestations | 7/170 | 4/170 | 5/171 |
| GastroenteritisInfections and infestations | 7/170 | 6/170 | 2/171 |
| Upper respiratory tract infectionInfections and infestations | 5/170 | 4/170 | 4/171 |
| Event | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group |
|---|---|---|---|
| PainGeneral disorders | 127/170 | 133/170 | 140/171 |
| IrritabilityGeneral disorders | 124/170 | 131/170 | 118/171 |
| PainGeneral disorders | 126/170 | 116/170 | — |
| FeverGeneral disorders | 102/170 | 95/170 | 75/171 |
| DrowsinessGeneral disorders | 82/170 | 97/170 | 72/171 |
| Loss of appetiteGeneral disorders | 68/170 | 83/170 | 70/171 |
| NasopharyngitisInfections and infestations | 53/170 | 62/170 | 71/171 |
| SwellingGeneral disorders | 47/170 | 68/170 | 68/171 |
| Upper respiratory tract infectionInfections and infestations | 66/170 | 66/170 | 65/171 |
| PainGeneral disorders | 52/163 | 54/161 | 47/159 |
| Age, Continuous(Weeks) | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group | Total |
|---|---|---|---|---|
| Mean | 7.0 ± 0.97 | 7.1 ± 1.05 | 7.0 ± 0.97 | 7.0 ± 1.00 |
| Sex: Female, Male(Participants) | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group | Total |
|---|---|---|---|---|
| Female | 90 | 84 | 78 | 252 |
| Male | 80 | 86 | 93 | 259 |
| Region of Enrollment(Subjects) | GSK 257049 1 Group | GSK 257049 2 Group | Tritanrix™ HepB/Hiberix™ Group | Total |
|---|---|---|---|---|
| Gabon | 73 | 73 | 74 | 220 |
| Ghana | 27 | 27 | 27 | 81 |
| Tanzania | 70 | 70 | 70 | 210 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
The record gives a start of Apr 2007, a primary completion of Sep 2008 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.
Results were first posted in May 2013, 4 years 8 months after primary completion. A results delay was requested in Feb 2012.
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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