A Phase 3 interventional study of Vitamin A and Candidate Plasmodium falciparum malaria vaccine in Malaria and Malaria Vaccines, sponsored by GlaxoSmithKline. Completed at 2 sites in Ghana. Open to participants aged 6 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
Among 41 studies in Malaria by GlaxoSmithKline — 3 open to participants now, 3 under way, none of them phase 3. Malaria · GlaxoSmithKline.
Among the 41 studies in Malaria by GlaxoSmithKline, this one is the 11th largest by enrollment of the 38 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 in phase 3, and was the 31st registered.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
Browse Malaria studies →3 of the 41 studies in Malaria by GlaxoSmithKline are open now, in 4 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Gabon, Uganda
Ages 18–65
GlaxoSmithKline · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
GlaxoSmithKline · Sites in Rwanda
Ages 5 mo–60 mo · Healthy volunteers
By country, each count listing its studies:
Of the 51 Malaria studies recruiting now, 15 (29%) set no upper age limit and 33 (65%) stop at 75 or younger; 37 take children under 18; 31 take healthy volunteers.
This study: 6 Months to 6 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 699 is above the median of 252 across 937 interventional studies indexed under Malaria.
Median enrollment 207 across the 38 interventional studies, 36,366 across the 3 observational. Of the 38 that completed or were terminated, 23 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
2 of the studies in Malaria by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07036159GlaxoSmithKlineA Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months | 2027-04-23 |
| NCT07545681GlaxoSmithKlineA Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria | 2027-10-08 |
Add all 2 to your calendar (.ics) → With an account.
Among the 41 studies in Malaria by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with a minor illness without fever might have been enrolled at the discretion of the investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
Dietary Supplement: Vitamin A · Biological: Candidate Plasmodium falciparum malaria vaccine · Biological: MR-Vac · Biological: Stamaril
Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).
Dietary Supplement: Vitamin A · Biological: Candidate Plasmodium falciparum malaria vaccine · Biological: MR-Vac · Biological: Stamaril
Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Dietary Supplement: Vitamin A · Biological: Candidate Plasmodium falciparum malaria vaccine · Biological: MR-Vac · Biological: Stamaril
Oral administration of Vitamin A (1 dose)
Intramuscular administration of SB257049 vaccine (4 doses)
Also known as: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine adjuvanted with GSK Biologicals' proprietary Adjuvant System AS01E (RTS,S/AS01E)
Subcutaneous injection of a combined measles and rubella vaccine (1 dose)
Also known as: Live attenuated measles virus and rubella virus vaccine (MR-Vac)
Intramuscular injection of a yellow fever (YF) vaccine (1 dose)
Also known as: Yellow Fever (YF) Vaccine
Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis)
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
Time frame: At one month post Dose 3 of SB257049 (Month 4)
Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis)
Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end.
Time frame: At one month post Dose 3 of SB257049 (Month 4)
Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: ELISA units per milliliter (EU/mL). The 95% CI for the GMC was obtained by exponential transformation (base 10) of the 95% CI for the mean of the log transformed concentrations. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049
A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-CS ≥ 1.9 ELISA unit per milliliter \[EU/mL\]). Seropositivity was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049
Concentrations were expressed as GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-HB was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049
Seroprotection rate for anti-HBs antibody was defined as the percentage of subjects with antibody concentrations greater than or equal to an established cut-off value (anti-HBs ≥ 10 milli-international unit per milliliter \[mIU/mL\]). Seroprotection was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post-Dose 3 of SB257049 (Month 4)
Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine
Seroconversion was defined as number of subjects with an anti-Measles antibodies pre-vaccination concentration below 150 mIU/mL and a post-vaccination concentration ≥150 mIU/mL. Seroconversion was assessed in the Coad group and the Control group.
Time frame: At one month post-vaccination with the combined measles and rubella (MeRu) vaccine (Month 4)
Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
Concentrations were expressed in GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-Me was assessed in the Coad Group and the Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)
Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Me ≥ 150 mIU/mL). Seropositivity was assessed in the Coad Group and the Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with the combined measles and rubella vaccine (Month 4)
Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine
Seroconversion was defined as number of subjects with an anti-Ru pre-vaccination concentration less than (\<) 4 IU/mL and a post-vaccination concentration ≥ 4 IU/mL. Seroconversion was assessed in the Coad group and Control group.
Time frame: At one month post-vaccination with combined measles and rubella vaccine (Month 4)
Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
Concentrations were expressed as GMCs with the following unit of measure: International unit per milliliter (IU/mL). The antibody response of anti-Ru was assessed in the Coad Group and Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)
Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
A subject seropositive for anti-Ru antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Ru ≥ 4 IU/mL). Seropositivity was assessed in the Coad Group and Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)
Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine
Seropositivity was defined as number of subjects with anti-YF titers greater than or equal to (≥) 10 End point Dilution 50 (ED50). Seropositivity was assessed in the Coad group and Control group.
Time frame: At one month post-vaccination with the YF vaccine (Month 4)
Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine
Titers were expressed as Geometric Mean Titres (GMTs). The antibody response of anti-YF was assessed in the Coad Group and Control Group.
Time frame: At one month post-vaccination with the YF vaccine (Month 4)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A (Day 0)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) at injection site.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)
Number of Subjects With Solicited General Symptoms for the Control Group, After Visit at 7.5 Months of Age
Solicited symptoms were not analyzed for the Control Group after visit at Month 1.5 because no vaccination was administered at that visit.
Time frame: After visit at Month 1.5
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.
Time frame: During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)
Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age
An unsolicited adverse event is any adverse event (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.
Time frame: Within 30-day (Days 0-29) period after dose 1 of SB257049 and Vitamin A- Coad and RTS,S Groups, and 30-day period after Vitamin A administration - Control Group
Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age
An unsolicited adverse event is any adverse event (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.
Time frame: Within 30-day (Day of vaccination and 29 subsequent days) period after dose 2 of SB257049 administered at Month 1.5 - Coad and RTS,S Groups
Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age
An unsolicited adverse event is any adverse event (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.
Time frame: During the 30-day period (Day of the visit and 29 subsequent days) after the visit at Month 1.5
Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age
An unsolicited adverse event is any adverse event (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.
Time frame: Within 42-day (vaccination day and 41 subsequent days) period after dose 3 of SB257049 in Coad (+MeRu+YF vaccines) and RTS,S groups, and 42-day period after MeRU+YF vaccination in Control group, administered at Month 3
Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During 30-Days period (Day of vaccination and 29 subsequent days) following each administration at Day 0, Month1.5 and Month 3 for Coad and RTS,S groups and at Day 0 and Month 3 in the Control Group.
Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 up to Month 4.5
Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
Time frame: From Day 0 up to Month 4.5
Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to Month 4.5
Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
Time frame: Within 30 days post-vaccination for vaccine doses administered at Day 0, Month 1.5 or 42 days post-vaccination (doses given at Month 3 [Coad & Control Groups] or Month 4.5 [RTS,S Group]) vaccination period from Day 0 until Month 4.5
Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups)
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
Time frame: Within 7 days after vaccines administered at Day 0 and Month 1.5 for the Coad and RTS,S groups and 14 days after vaccines administered at Month 3 for all groups
Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age
An unsolicited adverse event is any adverse event (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.
Time frame: During the 30-day period (Day of vaccination and 29 subsequent days) after booster dose administered at Month 21
Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age
An unsolicited adverse event is any adverse event (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.
Time frame: During the 30-Day Period (Day of vaccination and 29 subsequent days) after primary doses of study vaccine administered at Month 4.5, Month 5.5, Month 6.5 (across primary doses), and after booster dose administered at Month 24
Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)
Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
Time frame: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)
Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
Time frame: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)
Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for Coad and RTS,S Groups.
Time frame: Within 30 days post-vaccination (doses given at Day 0, Month 1.5, Month 21) & 42 days post-vaccination (dose given at Month 3 [Coad Group] or Month 4.5 [RTS,S Group])
Number of Subjects With Seizures for Vaccines Doses Administered at 10.5, 11.5, 12.5, 30 and 9 Months of Age for Control Group
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for the Control Group.
Time frame: Within 30 days post-vaccination (doses given at Month 4.5, Month 5.5, Month 6.5, Month 24) & 42 days post-vaccination (dose given at Month 3)
| Milestone | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Started | 231 | 236 | 232 |
| Completed | 223 | 233 | 226 |
| Not completed | 8 | 3 | 6 |
| Withdrew: Adverse event | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Consent withdrawal not due to adv. event | 7 | 2 | 4 |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
| EU/mL | Coad Group | RTS,S Group |
|---|---|---|
| Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis) | 452.87 (409.85 to 500.41) | 422.49 (382.89 to 466.18) |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: ELISA units per milliliter (EU/mL). The 95% CI for the GMC was obtained by exponential transformation (base 10) of the 95% CI for the mean of the log transformed concentrations. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
| EU/mL | Coad Group | RTS,S Group |
|---|---|---|
| Anti-CS - Day 0 | 0.96 (0.94 to 0.97) | 0.96 (0.94 to 0.98) |
| Anti-CS - Month 4 | 454.51 (408.58 to 505.60) | 422.49 (385.42 to 463.12) |
A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-CS ≥ 1.9 ELISA unit per milliliter \[EU/mL\]). Seropositivity was assessed in the Coad Group and the RTS,S Group.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Anti-CS - Day 0 | 1 | 2 |
| Anti-CS - Month 4 | 207 | 213 |
Concentrations were expressed as GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-HB was assessed in the Coad Group and the RTS,S Group.
| mIU/mL | Coad Group | RTS,S Group |
|---|---|---|
| Anti-HBs - Day 0 | 397.36 (318.21 to 496.18) | 427.65 (340.47 to 537.14) |
| Anti-HBs - Month 4 | 42162.55 (35643.11 to 49874.45) | 43261.19 (37275.19 to 50208.47) |
Seroprotection rate for anti-HBs antibody was defined as the percentage of subjects with antibody concentrations greater than or equal to an established cut-off value (anti-HBs ≥ 10 milli-international unit per milliliter \[mIU/mL\]). Seroprotection was assessed in the Coad Group and the RTS,S Group.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Anti-HB - Day 0 | 196 | 201 |
| Anti-HB - Month 4 | 205 | 210 |
Seroconversion was defined as number of subjects with an anti-Measles antibodies pre-vaccination concentration below 150 mIU/mL and a post-vaccination concentration ≥150 mIU/mL. Seroconversion was assessed in the Coad group and the Control group.
| Participants | Coad Group | Control Group |
|---|---|---|
| Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine | 197 | 212 |
Concentrations were expressed in GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-Me was assessed in the Coad Group and the Control Group.
| mIU/mL | Coad Group | Control Group |
|---|---|---|
| Anti-Me - Month 3 | 75.00 (75.00 to 75.00) | 75.00 (75.00 to 75.00) |
| Anti-Me - Month 4 | 565.81 (513.40 to 623.57) | 572.09 (523.83 to 624.79) |
A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Me ≥ 150 mIU/mL). Seropositivity was assessed in the Coad Group and the Control Group.
| Participants | Coad Group | Control Group |
|---|---|---|
| Anti-Me - Month 3 | 0 | 0 |
| Anti-Me - Month 4 | 200 | 213 |
Seroconversion was defined as number of subjects with an anti-Ru pre-vaccination concentration less than (\<) 4 IU/mL and a post-vaccination concentration ≥ 4 IU/mL. Seroconversion was assessed in the Coad group and Control group.
| Participants | Coad Group | Control Group |
|---|---|---|
| Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine | 199 | 212 |
Concentrations were expressed as GMCs with the following unit of measure: International unit per milliliter (IU/mL). The antibody response of anti-Ru was assessed in the Coad Group and Control Group.
| IU/mL | Coad Group | Control Group |
|---|---|---|
| Anti-Ru - Month 3 | 2.08 (1.99 to 2.18) | 2.09 (1.98 to 2.20) |
| Anti-Ru - Month 4 | 39.36 (35.20 to 44.01) | 42.45 (38.42 to 46.92) |
A subject seropositive for anti-Ru antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Ru ≥ 4 IU/mL). Seropositivity was assessed in the Coad Group and Control Group.
| Participants | Coad Group | Control Group |
|---|---|---|
| Anti-Ru - Month 3 | 5 | 4 |
| Anti-Ru - Month 4 | 207 | 217 |
Seropositivity was defined as number of subjects with anti-YF titers greater than or equal to (≥) 10 End point Dilution 50 (ED50). Seropositivity was assessed in the Coad group and Control group.
| Participants | Coad Group | Control Group |
|---|---|---|
| Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine | 203 | 214 |
Titers were expressed as Geometric Mean Titres (GMTs). The antibody response of anti-YF was assessed in the Coad Group and Control Group.
| Titers | Coad Group | Control Group |
|---|---|---|
| Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine | 324.31 (273.54 to 384.51) | 346.60 (296.73 to 404.86) |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Pain - Any | 25 | 16 |
| Pain - Grade 3 | 0 | 1 |
| Redness - Any | 7 | 13 |
| Redness - Grade 3 | 0 | 0 |
| Swelling - Any | 8 | 6 |
| Swelling - Grade 3 | 0 | 0 |
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Drowsiness - Any | 4 | 4 |
| Drowsiness - Grade 3 | 0 | 0 |
| Drowsiness - Related | 0 | 0 |
| Drowsiness - Grade 3 related | 0 | 0 |
| Irritability/Fussiness - Any | 14 | 22 |
| Irritability/Fussiness - Grade 3 | 1 | 1 |
| Irritability/Fussiness - Related | 2 | 1 |
| Irritability/Fussiness - Grade 3 related | 0 | 0 |
| Loss of appetite - Any | 5 | 7 |
| Loss of appetite - Grade 3 | 0 | 0 |
| Loss of appetite - Related | 0 | 0 |
| Loss of appetite - Grade 3 related | 0 | 0 |
| Measles/Rubella-like rash - Any | 0 | 0 |
| Measles/Rubella-like rash - Grade 3 | 0 | 0 |
| Measles/Rubella-like rash - Related | 0 | 0 |
| Measles/Rubella-like rash - Grade 3 related | 0 | 0 |
| Fever - Any | 32 | 30 |
| Fever - Grade 3 | 3 | 1 |
| Fever - Related | 10 | 8 |
| Fever - Grade 3 related | 1 | 0 |
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
| Participants | Control Group |
|---|---|
| Drowsiness - Any | 1 |
| Drowsiness - Grade 3 | 0 |
| Drowsiness - Related | 0 |
| Drowsiness - Grade 3 related | 0 |
| Irritability/Fussiness - Any | 6 |
| Irritability/Fussiness - Grade 3 | 1 |
| Irritability/Fussiness - Related | 0 |
| Irritability/Fussiness - Grade 3 related | 0 |
| Loss of appetite - Any | 9 |
| Loss of appetite- Grade 3 | 0 |
| Loss of appetite- Related | 0 |
| Loss of appetite- Grade 3 related | 0 |
| Measles/Rubella-like rash - Any | 0 |
| Measles/Rubella-like rash - Grade 3 | 0 |
| Measles/Rubella-like rash - Related | 0 |
| Measles/Rubella-like rash - Grade 3 related | 0 |
| Fever - Any | 11 |
| Fever - Grade 3 | 0 |
| Fever - Related | 1 |
| Fever - Grade 3 related | 0 |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) at injection site.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Pain - Any | 3 | 12 |
| Pain - Grade 3 | 0 | 0 |
| Redness - Any | 4 | 2 |
| Redness - Grade 3 | 1 | 0 |
| Swelling - Any | 4 | 6 |
| Swelling - Grade 3 | 0 | 0 |
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Drowsiness - Any | 6 | 5 |
| Drowsiness - Grade 3 | 0 | 0 |
| Drowsiness - Related | 1 | 2 |
| Drowsiness - Grade 3 related | 0 | 0 |
| Irritability/Fussiness - Any | 11 | 13 |
| Irritability/Fussiness - Grade 3 | 0 | 1 |
| Irritability/Fussiness - Related | 4 | 2 |
| Irritability/Fussiness - Grade 3 related | 0 | 0 |
| Loss of appetite - Any | 6 | 11 |
| Loss of appetite - Grade 3 | 0 | 0 |
| Loss of appetite - Related | 1 | 0 |
| Loss of appetite - Grade 3 related | 0 | 0 |
| Measles/Rubella-like rash - Any | 0 | 0 |
| Measles/Rubella-like rash - Grade 3 | 0 | 0 |
| Measles/Rubella-like rash - Related | 0 | 0 |
| Measles/Rubella-like rash - Grade 3 related | 0 | 0 |
| Fever - Any | 47 | 47 |
| Fever - Grade 3 | 3 | 3 |
| Fever - Related | 11 | 9 |
| Fever - Grade 3 related | 1 | 1 |
Solicited symptoms were not analyzed for the Control Group after visit at Month 1.5 because no vaccination was administered at that visit.
No measurements were reported for this outcome.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Pain - Any | 10 | 10 | 1 |
| Pain - Grade 3 | 0 | 0 | 0 |
| Redness - Any | 0 | 1 | 2 |
| Redness - Grade 3 | 0 | 0 | 0 |
| Swelling - Any | 3 | 3 | 1 |
| Swelling - Grade 3 | 0 | 0 | 0 |
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Drowsiness - Any | 7 | 6 | 0 |
| Drowsiness - Grade 3 | 0 | 0 | 0 |
| Drowsiness - Related | 4 | 5 | 0 |
| Drowsiness - Grade 3 related | 0 | 0 | 0 |
| Irritability/Fussiness - Any | 11 | 8 | 1 |
| Irritability/Fussiness - Grade 3 | 0 | 0 | 0 |
| Irritability/Fussiness - Related | 4 | 4 | 0 |
| Irritability/Fussiness - Grade 3 related | 0 | 0 | 0 |
| Loss of appetite - Any | 8 | 6 | 2 |
| Loss of appetite - Grade 3 | 0 | 0 | 0 |
| Loss of appetite - Related | 2 | 2 | 0 |
| Loss of appetite - Grade 3 related | 0 | 0 | 0 |
| Measles/Rubella-like rash - Any | 0 | 0 | 0 |
| Measles/Rubella-like rash - Grade 3 | 0 | 0 | 0 |
| Measles/Rubella-like rash - Related | 0 | 0 | 0 |
| Measles/Rubella-like rash - Grade 3 related | 0 | 0 | 0 |
| Fever - Any | 54 | 50 | 17 |
| Fever - Grade 3 | 3 | 2 | 2 |
| Fever - Related | 26 | 23 | 8 |
| Fever - Grade 3 related | 1 | 1 | 1 |
An unsolicited adverse event is any adverse event (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.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age | 116 | 119 | 111 |
An unsolicited adverse event is any adverse event (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.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age | 107 | 109 |
An unsolicited adverse event is any adverse event (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.
| Participants | Control Group |
|---|---|
| Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age | 80 |
An unsolicited adverse event is any adverse event (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.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age | 120 | 121 | 125 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Any SAEs | 13 | 8 | 16 |
| Fatal SAEs | 1 | 0 | 1 |
| Related SAEs | 0 | 0 | 0 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5 | 14 | 12 | 21 |
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5 | 0 | 0 | 0 |
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5 | 0 | 0 | 0 |
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age | 0 | 0 | 0 |
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups) | 0 | 0 | 0 |
An unsolicited adverse event is any adverse event (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.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age | 62 | 67 |
An unsolicited adverse event is any adverse event (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.
| Participants | Control Group |
|---|---|
| Across primary doses | 160 |
| At Month 24 | 57 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End | 61 | 62 | 66 |
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End | 0 | 1 | 0 |
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
| Participants | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End | 0 | 1 | 1 |
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for Coad and RTS,S Groups.
| Participants | Coad Group | RTS,S Group |
|---|---|---|
| Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group | 0 | 0 |
Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end.
| EU/mL | Coad Group | RTS,S Group |
|---|---|---|
| Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis) | 454.51 (411.43 to 502.11) | 422.49 (382.89 to 466.18) |
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for the Control Group.
| Participants | Control Group |
|---|---|
| Number of Subjects With Seizures for Vaccines Doses Administered at 10.5, 11.5, 12.5, 30 and 9 Months of Age for Control Group | 1 |
Collected over Solicited local & general AEs: Coad & RTS,S groups over 7-day follow-up period (FU) after vaccination at 6 & 7.5 Months of age (Mth-age); Control group at 6 Mth-age; all groups 14-Day FU after vaccination at 9 Mth-age. Unsolicited AEs: Coad & RTS,S groups over 30-Day FU after vaccination at 6, 7.5 & 27 Mth-age; Control group at 6, 10.5, 11.5, 12.5 & 30 Mth-age; all groups 42-Day FU after vaccination at 9 Mth-age. SAEs: Coad & RTS,S groups Day 0-Month 33; Control Group: Day 0-Month 36. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coad Group | 2/231 (0.9%) | 61/231 (26.4%) | 219/231 (94.8%) |
| RTS,S Group | 0/236 (0%) | 62/236 (26.3%) | 221/236 (93.6%) |
| Control Group | 3/232 (1.3%) | 66/232 (28.4%) | 207/232 (89.2%) |
| Event | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Plasmodium falciparum infectionInfections and infestations | 21/231 | 29/236 | 21/232 |
| PneumoniaInfections and infestations | 15/231 | 12/236 | 17/232 |
| GastroenteritisInfections and infestations | 16/231 | 17/236 | 13/232 |
| MalariaInfections and infestations | 6/231 | 3/236 | 11/232 |
| SepsisInfections and infestations | 9/231 | 2/236 | 8/232 |
| Otitis mediaInfections and infestations | 2/231 | 5/236 | 4/232 |
| AnaemiaBlood and lymphatic system disorders | 0/231 | 3/236 | 4/232 |
| Lower respiratory tract infectionInfections and infestations | 3/231 | 3/236 | 1/232 |
| Upper respiratory tract infectionInfections and infestations | 3/231 | 1/236 | 0/232 |
| Urinary tract infectionInfections and infestations | 3/231 | 2/236 | 3/232 |
| Event | Coad Group | RTS,S Group | Control Group |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 143/231 | 149/236 | 168/232 |
| GastroenteritisInfections and infestations | 103/231 | 120/236 | 119/232 |
| PyrexiaGeneral disorders | 101/231 | 95/236 | 28/232 |
| Respiratory tract infectionInfections and infestations | 67/231 | 68/236 | 84/232 |
| MalariaInfections and infestations | 44/231 | 51/236 | 76/232 |
| EnteritisGastrointestinal disorders | 37/231 | 42/236 | 54/232 |
| PneumoniaInfections and infestations | 40/231 | 33/236 | 30/232 |
| Injection site painGeneral disorders | 38/231 | 31/236 | 1/232 |
| Irritability postvaccinalGeneral disorders | 31/231 | 37/236 | 6/232 |
| ConjunctivitisInfections and infestations | 26/231 | 25/236 | 31/232 |
| Age, Continuous(Months) | Coad Group | RTS,S Group | Control Group | Total |
|---|---|---|---|---|
| Mean | 6.3 ± 0.3 | 6.3 ± 0.3 | 6.3 ± 0.3 | 6.3 ± 0.3 |
| Sex: Female, Male(Participants) | Coad Group | RTS,S Group | Control Group | Total |
|---|---|---|---|---|
| Female | 116 | 119 | 113 | 348 |
| Male | 115 | 117 | 119 | 351 |
| Race/Ethnicity, Customized(Participants) | Coad Group | RTS,S Group | Control Group | Total |
|---|---|---|---|---|
| BLACK OR AFRICAN AMERICAN | 231 | 236 | 232 | 699 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from May 2017 to primary completion in Mar 2018, 10 months.
Results were first posted in Aug 2019, 1 year 5 months after primary completion.
Of 50 phase 3 interventional studies under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 31. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Vitamin A · Yellow Fever Vaccine