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NCT00307021
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
Phase 2 trial testing GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 in Malaria in 180 participants. Completed in 22 August 2007.
15 September 2006
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 180 |
| Start date | 7 April 2006 |
| Primary completion | 15 September 2006 |
| Estimated completion | 22 August 2007 |
| Sites | 1 location across Gabon |
Drugs / interventions tested
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Conditions studied
- Malaria — all drugs for Malaria →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 Months to 48 Months, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunomodulatory Nanosystems.
Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101 -
Virus-like particle vaccinology, from bench to bedside.
Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8 -
Liposome-Based Adjuvants for Subunit Vaccines: Formulation Strategies for Subunit Antigens and Immunostimulators.
Tandrup Schmidt S, Foged C, Korsholm KS, Rades T, et al · · 2016 · cited 127× · PMID 26978390 · DOI 10.3390/pharmaceutics8010007 -
A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon.
Lell B, Agnandji S, von Glasenapp I, Haertle S, et al · · 2009 · cited 65× · PMID 19859560 · DOI 10.1371/journal.pone.0007611 -
Induction of Plasmodium falciparum-specific CD4+ T cells and memory B cells in Gabonese children vaccinated with RTS,S/AS01(E) and RTS,S/AS02(D).
Agnandji ST, Fendel R, Mestré M, Janssens M, et al · · 2011 · cited 35× · PMID 21494604 · DOI 10.1371/journal.pone.0018559
Verify or expand the search:
- PubMed search for NCT00307021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Trials testing the same drug.
- NCT00360230 — Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children · Phase 2 · completed
Other recruiting trials for Malaria
Currently open trials in the same condition.
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- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
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Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00307021 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 25 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00307021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing