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GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.
In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI) regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
All infants participating in this phase I/IIb study will receive TETRActHib (a licensed diphtheria-tetanus-pertussis Haemophilus influenzae vaccine manufactured by Aventis Pasteur) by IM injection in their right thigh at 8, 12, and 16 weeks; They will be randomized to receive either the candidate malaria vaccine, GSK 257049 vaccine (0.5 ml dose) or Engerix-B (a licensed hepatitis B vaccine manufactured by GSK Biologicals) by IM injection in their left thigh at 10, 14, 18 weeks. Infants will be followed-up daily for 7 days after each vaccine dose for evaluation of safety and reactogenicity. There will be a 14-day follow-up period after each dose of TETRActHib and after Dose 1 and Dose 2 of GSK 257049 vaccine or Engerix-B, and a one month follow-up period after Dose 3 of GSK 257049 vaccine or Engerix-B for reporting unsolicited symptoms. Serious adverse events will be recorded throughout the 14 month study period. A small amount of blood (2 ml = 1/2 teaspoon) will be obtained at four different time points to measure the immune response elicited by the vaccines administered during this study period. Preliminary indication of vaccine efficacy in this age group will be established by actively monitoring for infection with Plasmodium falciparum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTS,S/AS02D Group | Experimental | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
|
| Engerix-B Group | Active Comparator | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTS,S/AS02D | Biological | 3-dose intramuscular injection in the thigh |
| |
| 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 6 |
| 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. | Throughout the entire study period (from Month 0 to Month 14) |
| Concentrations of Antibodies Against Hepatitis B (Anti-HB) |
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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 | Maputo | Mozambique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21079803 | Background | Aide P, Aponte JJ, Renom M, Nhampossa T, Sacarlal J, Mandomando I, Bassat Q, Manaca MN, Leach A, Lievens M, Vekemans J, Dubois MC, Loucq C, Ballou WR, Cohen J, Alonso PL. Safety, immunogenicity and duration of protection of the RTS,S/AS02(D) malaria vaccine: one year follow-up of a randomized controlled phase I/IIb trial. PLoS One. 2010 Nov 4;5(11):e13838. doi: 10.1371/journal.pone.0013838. | |
| 17949807 |
| 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 |
|---|---|---|---|
| 103967 | Study Protocol | 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 2 phases, a double-blind vaccination phase from Month 0 to Month 6, and a single-blind phase (Month 7 to Month 14).
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| ID | Title | Description |
|---|---|---|
| FG000 | RTS,S/AS02D Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
| FG001 | Engerix-B Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RTS,S/AS02D Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
| Units | Counts |
|---|---|
| Participants |
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| 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 for whom data were available. | Posted | Number | subjects | From Month 0 to Month 6 |
|
SAEs: entire study period (Months 0-14); Unsolicited AEs: Days 0-13 or 0-29 periods (as specified in notes); Solicited local/general symptoms: 7 day (Days 0-6) follow-up period after any vaccination.
For solicited symptoms and unsolicited AEs assessed following vaccination, the number of participants at risk included those vaccinated subjects from the Total Vaccinated cohort who had the symptom sheet completed.
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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 | RTS,S/AS02D Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C000719547 | RTS malaria vaccine |
| C075654 | Engerix-B |
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| TETRActHib™ |
| Biological |
3-dose intramuscular injection in the thigh. |
|
| Engerix-B® | Biological | 3-dose intramuscular injection in the thigh. |
|
Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL. |
| Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104). |
| Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies. | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL. | Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180). |
| Concentrations of Antibodies Against Anti-diphtheria (Anti-D) | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL. | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
| Concentrations of Antibodies Against Tetanus (Anti-T) | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL. | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
| Concentrations of Anti-Bordetella Pertussis Toxin 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 cut-off of the assay was 15 EL.U/mL. | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
| Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP). | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL. | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
| Time to First Malaria Infection | Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. | Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6) |
| Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) | Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. | At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine) |
| Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia | The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. | At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine) |
| Number of Subjects With Solicited Local Symptoms. | Assessed solicited local symptoms were pain and swelling at injection site. | During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine. |
| Number of Subjects With Solicited Local Symptoms. | Assessed solicited local symptoms were pain and swelling at injection site. | During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine. |
| Number of Subjects With Solicited General Symptoms. | Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C). | During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine |
| Number of Subjects With Solicited General Symptoms. | Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C). | During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine |
| 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. | During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine |
| 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. | During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine. |
| 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. | During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine. |
| Background |
| Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q, Sacarlal J, Manaca MN, Lafuente S, Barbosa A, Leach A, Lievens M, Vekemans J, Sigauque B, Dubois MC, Demoitie MA, Sillman M, Savarese B, McNeil JG, Macete E, Ballou WR, Cohen J, Alonso PL. Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet. 2007 Nov 3;370(9598):1543-51. doi: 10.1016/S0140-6736(07)61542-6. Epub 2007 Oct 18. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103967 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103967 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103967 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103967 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103967 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Other |
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| BG001 | Engerix-B Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Engerix-B Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. |
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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 for whom data were available. | Posted | Number | subjects | Throughout the entire study period (from Month 0 to Month 14) |
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| Secondary | Concentrations of Antibodies Against Hepatitis B (Anti-HB) | Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/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 outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104). |
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| Secondary | Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies. | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 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 outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180). |
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| Secondary | Concentrations of Antibodies Against Anti-diphtheria (Anti-D) | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay 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 outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
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| Secondary | Concentrations of Antibodies Against Tetanus (Anti-T) | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay 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 outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
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| Secondary | Concentrations of Anti-Bordetella Pertussis Toxin 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 cut-off of the assay 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 outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
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| Secondary | Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP). | Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay 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 outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine) |
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| Secondary | Time to First Malaria Infection | Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. | The analysis was performed on the According-to-Protocol cohort for efficacy, 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 efficacy outcome variables were available. | Posted | Number | n/PYAR | Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6) |
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| Secondary | Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) | Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. | The analysis was performed on the According-to-Protocol cohort for efficacy, 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 efficacy outcome variables were available. | Posted | Number | subjects | At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine) |
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| Secondary | Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia | The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. | The analysis was performed on the According-to-Protocol cohort for efficacy, 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 efficacy outcome variables were available. | Posted | Mean | Full Range | Parasites per µL | At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine) |
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| Secondary | Number of Subjects With Solicited Local Symptoms. | Assessed solicited local symptoms were pain and swelling at injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine. |
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| Secondary | Number of Subjects With Solicited Local Symptoms. | Assessed solicited local symptoms were pain and swelling at injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine. |
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| Secondary | Number of Subjects With Solicited General Symptoms. | Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine |
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|
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| Secondary | Number of Subjects With Solicited General Symptoms. | Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine |
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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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine |
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|
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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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine. |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed. | Posted | Number | subjects | During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine. |
|
|
|
| 35 |
| 107 |
| 107 |
| 107 |
| EG001 | Engerix-B Group | Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. | 34 | 107 | 107 | 107 |
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Plasmodium falciparum infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Ascariasis | Infections and infestations | Non-systematic Assessment |
|
| Bronchial hyper reactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | Non-systematic Assessment |
|
| Malaria | Infections and infestations | Non-systematic Assessment |
|
| Mastoiditis | Infections and infestations | Non-systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | Non-systematic Assessment |
|
| Tinea capitis | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
|
| Swelling | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Drowsiness | General disorders | Systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Fever | General disorders | Systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Irritability | General disorders | Systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Loss of appetite | General disorders | Systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Malaria | Infections and infestations | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment | During the 14-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-BTM vaccine |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-BTM vaccine |
|
| Malaria | Infections and infestations | Non-systematic Assessment | During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine |
|
| Pyrexia | General disorders | Non-systematic Assessment | During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine |
|
| Pain | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Swelling | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Drowsiness | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Fever | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Irritability | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Loss of appetite | General disorders | Systematic Assessment | During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Malaria | Infections and infestations | Non-systematic Assessment | During the 30-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine |
|
| Ear infection | Infections and infestations | Non-systematic Assessment | During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine |
|
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 |
| Anti-CS, Day 180 [N=53;61] |
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| Irritability |
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| Loss of appetite |
|
| Irritability |
|
| Loss of appetite |
|