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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK 257049 | Biological | GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Month 0 to Month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Months 0, 1, 3 and 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Lambaréné | Gabon | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25885325 | Derived | 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. | |
| 23962071 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 106369 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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The study comprised a vaccination phase (Months 0-8) and a follow-up phase (Months 8-19). The Stamaril™ vaccine was not part of the EPI Tanzanian vaccination schedule at study planning. Hence this vaccine was not administered to subjects from Tanzania.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK 257049 1 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| FG001 | GSK 257049 2 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| FG002 | Tritanrix™ HepB/Hiberix™ Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK 257049 1 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | From Month 0 to Month 8 |
|
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.
3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK 257049 1 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C000719547 | RTS malaria vaccine |
| D022341 | Yellow Fever Vaccine |
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Tritanrix™ HepB/Hib | Biological | 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 | Aventis Pasteur's attenuated yellow fever vaccine. |
|
|
| Polio Sabin™ | Biological | GSK Biologicals' oral polio virus vaccine |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Month 0 to Month 19 |
| Kintampo |
| Ghana |
| GSK Investigational Site | Dar es Salaam | Tanzania |
| Derived |
| Warimwe GM, Fletcher HA, Olotu A, Agnandji ST, Hill AV, Marsh K, Bejon P. Peripheral blood monocyte-to-lymphocyte ratio at study enrollment predicts efficacy of the RTS,S malaria vaccine: analysis of pooled phase II clinical trial data. BMC Med. 2013 Aug 21;11:184. doi: 10.1186/1741-7015-11-184. |
| 21782519 | Derived | Asante KP, Abdulla S, Agnandji S, Lyimo J, Vekemans J, Soulanoudjingar S, Owusu R, Shomari M, Leach A, Jongert E, Salim N, Fernandes JF, Dosoo D, Chikawe M, Issifou S, Osei-Kwakye K, Lievens M, Paricek M, Moller T, Apanga S, Mwangoka G, Dubois MC, Madi T, Kwara E, Minja R, Hounkpatin AB, Boahen O, Kayan K, Adjei G, Chandramohan D, Carter T, Vansadia P, Sillman M, Savarese B, Loucq C, Lapierre D, Greenwood B, Cohen J, Kremsner P, Owusu-Agyei S, Tanner M, Lell B. Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. Lancet Infect Dis. 2011 Oct;11(10):741-9. doi: 10.1016/S1473-3099(11)70100-1. Epub 2011 Jul 22. |
| 20735271 | Derived | Agnandji ST, Asante KP, Lyimo J, Vekemans J, Soulanoudjingar SS, Owusu R, Shomari M, Leach A, Fernandes J, Dosoo D, Chikawe M, Issifou S, Osei-Kwakye K, Lievens M, Paricek M, Apanga S, Mwangoka G, Okissi B, Kwara E, Minja R, Lange J, Boahen O, Kayan K, Adjei G, Chandramohan D, Jongert E, Demoitie MA, Dubois MC, Carter T, Vansadia P, Villafana T, Sillman M, Savarese B, Lapierre D, Ballou WR, Greenwood B, Tanner M, Cohen J, Kremsner PG, Lell B, Owusu-Agyei S, Abdulla S. Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. J Infect Dis. 2010 Oct 1;202(7):1076-87. doi: 10.1086/656190. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106369 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106369 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106369 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106369 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106369 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Physician Decision |
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| Death |
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| Other |
|
| BG001 | GSK 257049 2 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| BG002 | Tritanrix™ HepB/Hiberix™ Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| BG003 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Subjects |
|
| OG001 | GSK 257049 2 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
| OG002 | Tritanrix™ HepB/Hiberix™ Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. |
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 0, 1, 3 and 7. |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 0, 3, 7 and 8. |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 0, 3, 7 and 8. |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Month 3 |
|
|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | From Month 8 to Month 19 |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 3 |
|
|
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| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Month 3 |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3 |
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|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 7 and 8. |
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|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Months 7 and 8. |
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|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 0, 1, 3 and 7. |
|
|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 0, 3, 7 and 8. |
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|
|
| Secondary | 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. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 0, 3, 7 and 8. |
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|
|
| Secondary | 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. | The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed. | Posted | Number | subjects | During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. |
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|
|
| Secondary | 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. | The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed. | Posted | Number | subjects | During the 7-day (Days 0-6) follow-up period after any vaccination |
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|
|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | During the 30-day (Days 0-29) follow-up period after any vaccination |
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|
| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Number | subjects | From Month 0 to Month 19 |
|
|
|
| 57 |
| 170 |
| 169 |
| 170 |
| EG001 | GSK 257049 2 Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. | 47 | 170 | 169 | 170 |
| EG002 | Tritanrix™ HepB/Hiberix™ Group | Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. | 49 | 171 | 171 | 171 |
|
| Plasmodium falciparum infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Impetigo | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Sepsis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Otitis media | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Enteritis | Gastrointestinal disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Acarodermatitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Escherichia urinary tract infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Salmonella sepsis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Sickle cell anaemia | Congenital, familial and genetic disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Acquired immunodeficiency syndrome | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Blepharitis | Eye disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Cataract congenital | Congenital, familial and genetic disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Convulsion | Nervous system disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Extrapulmonary tuberculosis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Hydrocele male infected | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Mastoiditis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Microcytic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Otitis media acute | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Periorbital abscess | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Pyrexia | General disorders | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Skin infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 0 and Month 8. |
|
| Plasmodium falciparum infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Impetigo | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Sepsis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Convulsion | Nervous system disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Microcytic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Otitis media | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Accidental exposure | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Acquired immunodeficiency syndrome | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Dysentery | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Glomerulonephritis | Renal and urinary disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Haemolytic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Otitis media acute | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Otitis media chronic | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Petroleum distillate poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Pneumonitis chemical | Injury, poisoning and procedural complications | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Pyelonephritis | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Pyrexia | General disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Skin infection | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Urinary tract infection pseudomonal | Infections and infestations | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment | SAE reported between Month 8 and Month 19. |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib |
|
| Pain | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with Rouvax™. |
|
| Pain | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with the GSK 257049 vaccine. |
|
| Pain | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with Stamaril™. |
|
| Swelling | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib |
|
| Swelling | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with Rouvax™. |
|
| Swelling | General disorders | Systematic Assessment | Solicited local symptom reported after vaccination with the GSK 257049 vaccine |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Induration | General disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D000079426 |
| Vector Borne Diseases |
| D023321 |
| Poliovirus Vaccines |
|
| Anti-HB, Month 7 [N=137] |
|
|
| Anti-HB, Month 8 [N=125] |
|
|
| Anti-HB, Month 8 [N=133] |
|
|
| Anti-Polio 2 [N=135;124;131] |
|
| Anti-Polio 3 [N=135;125;133] |
|
|
| Anti-CS, Month 7 [N=137] |
|
|
| Anti-CS, Month 8 [N=127] |
|
|
| Anti-CS, Month 8 [N=135] |
|
| Swelling - GSK 257049 [N=170;170;0] |
|
| Pain - Rouvax™ [N=163;161;159] |
|
| Swelling - Rouvax™ [N=163;161;159] |
|
| Pain - Stamaril™ [N=95;94;94] |
|
| Swelling - Stamaril™ [N=95;94;94] |
|
| Pain - Tritanrix™ HepB/Hib [N=170;170;171] |
|
| Swelling - Tritanrix™ HepB/Hib [N=170;170;171] |
|
|
| Irritability |
|
| Loss of appetite |
|