MalariaPhase 3NCT01323972
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
A Phase 3 study testing GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) in people with Malaria, run by GlaxoSmithKline at 2 sites in Nigeria.
Trial summary
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals. Read more about this study
- Who is it for?
- Ages 5 to 17 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 2 sitesNigeria
- Study dates
- 16 May 2011to 4 May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination.
- Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who have received three documented doses of hepatitis B vaccine.
Who cannot join
- Same sex twins.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
Show all 16Show fewer
- Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2.
- Acute disease and/or fever at the time of enrolment
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
- Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Administration of immunoglobulins and/or any blood products within 1 month preceding the first dose of study vaccine or planned administration during the study period.
- Child in care.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Consistency of Immunogenicity and Non Inferiority of Three Production Lots of GSK Biologicals' Candidate Malaria Vaccine in Children
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
- Conditions
- Malaria
- Being tested
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
- Keywords
- Malaria, Plasmodium falciparum
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)Biological
4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
| Study group | Role | What they receive |
|---|---|---|
| GSK 257049-Lot 1 Group | Experimental | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) |
| GSK 257049-Lot 2 Group | Experimental | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) |
| GSK 257049-Lot 3 Group | Experimental | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) |
| GSK 257049-Pilot Group | Experimental | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Circumsporozoite (Anti-CS) Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
Measured: One month post-dose 3 (Month 3)
Secondary outcomes (5)
Anti-hepatitis B (Anti-HB) Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Measured: One month post-dose 3 (Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of Subjects With Unsolicited Adverse Events
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Up to 8 months post-dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study start16 May 2011
- Primary completion22 Nov 2011
- Study completion4 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323972
- Sponsor's protocol ID
- 113398
- Status last verified
- Oct 2017
- First submitted
- 24 Feb 2011
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency of Immunogenicity and Non Inferiority of Three Production Lots of GSK Biologicals' Candidate Malaria Vaccine in Children
- ClinicalTrials.gov ID
- NCT01323972
- Acronym / sponsor ID
- 113398
- Conditions
- Malaria
- Keywords
- Malaria, Plasmodium falciparum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI)
- Study start
- 16 May 2011 (actual)
- Primary completion
- 22 Nov 2011 (actual)
- Study completion
- 4 May 2012 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GSK 257049-Lot 1 Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Lot 2 Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Lot 3 Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| GSK 257049-Pilot Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
Who may qualify
- Ages
- 5 to 17 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- A male or female child between, and including, 5 and 17 months of age at the time of the first vaccination.
- Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who have received three documented doses of hepatitis B vaccine.
Key exclusion criteria (16 listed)
- Same sex twins.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process | Biological | GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group, GSK 257049-Lot 3 Group, GSK 257049-Pilot Group |
Primary outcome
Anti-Circumsporozoite (Anti-CS) Antibody Titers
Time frame: One month post-dose 3 (Month 3)
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
5 secondary outcomes
Anti-hepatitis B (Anti-HB) Antibody Concentrations
Time frame: One month post-dose 3 (Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of Subjects With Unsolicited Adverse Events
Time frame: Within the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events
Time frame: Up to 8 months post-dose 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) in people with Malaria, run by GlaxoSmithKline at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Circumsporozoite (Anti-CS) Antibody Titers (time frame: One month post-dose 3 (Month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.