A Phase 2 interventional study of GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 in Malaria, sponsored by GlaxoSmithKline. Completed at 1 site in Gabon. Open to participants aged 18 Months to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by GlaxoSmithKline · Phase 2, 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 23rd largest by enrollment of the 38 interventional ones that give a count, is one of 3 that started in 2006, is one of 18 in phase 2, and was the 6th registered.
1,185 studies on the registry are indexed under Malaria; 80 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 52 Malaria studies recruiting now, 15 (29%) set no upper age limit and 34 (65%) stop at 75 or younger; 38 take children under 18; 32 take healthy volunteers.
This study: 18 Months to 48 Months · 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 2006.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 180 is below the median of 252 across 938 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.
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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:
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GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations
Occurrence of SAEs.
Time frame: From the time of first vaccination until one month post Dose 3
Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).
Time frame: One month post Dose 3.
Occurrence of solicited general and local reactions.
Time frame: Over a 7-day follow-up period after each vaccination.
Occurrence of unsolicited symptoms.
Time frame: After each vaccination over a 30-day follow-up
Anti-CS antibody titers.
Time frame: Prior to vaccination, one month post Dose 2
Anti-Hepatitis B surface agent (anti-HBs) antibody titers.
Time frame: Prior to vaccination, one month post Dose 2 and one month post Dose 3.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
The record gives a start of Apr 2006, a primary completion of Sep 2006 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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