MalariaPhase 2NCT00289185

Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants

A Phase 2 study testing RTS,S/AS02D, Engerix-B® and TETRActHib™ in people with Malaria and Malaria Vaccines, run by GlaxoSmithKline at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. Read more about this study

Who is it for?: Ages 6 to 10 weeksHealthy volunteers can take part
Conditions the study is for: Malaria, Malaria Vaccines
What is being tested?: RTS,S/AS02D, Engerix-B® and TETRActHib™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 340 participants
Where: 1 siteTanzania
Study dates: 27 Sep 2006to 15 Jan 2009
Phase: Phase 2
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 6 to 10 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
Born to a mother who is HBsAg negative \& HIV negative.
Born after a normal gestation period (between 36 and 42 weeks).
Subjects who live within a 5 km radius of a dispensary.

Who cannot join

Acute disease at the time of enrolment.
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Laboratory screening tests out of range for haemoglobin, total white cell count, platelets, ALT and creatinine.
Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
BCG administration within one week of proposed administration of a study vaccine.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).

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Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Previous participation in any other malaria vaccine trial.
Simultaneous participation in any other clinical trial.
Same sex twin.
Maternal death.
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
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

1 site in 1 country.

Tanzania1 site

GSK Investigational Site
Dar es Salaam

Other trials in Tanzania

About this study

Official title: A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes DTPw/Hib in Infants Living in a Malaria-endemic Region.

In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Read the detailed description

This is a phase 2b trial designed to evaluate the safety and immunogenicity of RTS,S/AS02D when co-administered with a multivalent DTPw/Hib (Aventis Pasteur's TETRActHib vaccine). Infants randomized to the control group will receive a licensed hepatitis B vaccine, Engerix-B in place of RTS,S/AS02D.

Data pertaining to RTS,S/AS02D or Engerix-B will be collected in a double blinded manner; data relating to TETRActHib will be collected in an open fashion.

Oral polio vaccine (OPV) will be administered at birth, 8, 12, 16 weeks in co-administration with other vaccines and will not be administered as part of this protocol. Antibody titers to OPV will not be assessed as part of this protocol.

Conditions: Malaria, Malaria Vaccines
Being tested: RTS,S/AS02D, Engerix-B®, TETRActHib™
Keywords: Coccidiosis, Parasitic Diseases, Malaria, Falciparum, Malaria
Medical subject headings: Malaria, Coccidiosis, Parasitic Diseases, Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RTS,S/AS02DBiological
Also called GSK 257146, RTS, S/AS02D
3-dose intramuscular injection in the thigh
Engerix-B®Biological
3-dose intramuscular injection in the thigh.
TETRActHib™Biological
Also called DTPw/Hib
3-dose intramuscular injection in the thigh.

Study groups in NCT00289185
Study group	Role	What they receive
RTS,S/AS02D Group	Experimental	Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. Receives: Biological: RTS,S/AS02D; Biological: TETRActHib™
Engerix-B Group	Active comparator	Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.. Receives: Biological: Engerix-B®; Biological: TETRActHib™

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentrations of Antibodies Against Hepatitis B (Anti-HB)
Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Week 0 to Month 9.
Concentrations of Antibodies Against Diphtheria (Anti-D)
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Concentrations of Antibodies Against Tetanus (Anti-T)
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 9 to Month 20.
Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.
Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Measured: Prior to vaccination at Week 0 (PRE), and at Month 3.

Secondary outcomes (9)

Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of 0.5 EL.U/mL.
Measured: Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain and swelling following vaccination with the RTS,S/AS02D or Engerix-B vaccine.
Measured: Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain and swelling following vaccination with the TETRActHib vaccine..
Measured: Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, fever, irritability, and loss of appetite. Fever was defined as axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C).
Measured: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs).
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.
Measured: Within 30 days (Days 0-29) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Throughout the entire study, from Week 0 to Month 20.
Time to First Malaria Infection
Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.
Measured: Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).
Number of Subjects Prevalent for Parasitemia
Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.
Measured: At Month 9
Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia
The parasite density in subjects prevalent for P. falciparum parasitemia (Subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 7 months after administration of Dose 3 of RTS,S or HBV vaccine (Month 9). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. This outcome for solely assessed in the Engerix-B Group, as no subject in the RTS,S/AS02D was assessed as prevalent for parasitemia.
Measured: At Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 200615 Jan 2009

First posted9 Feb 2006 (estimated)
Study start27 Sep 2006
Primary completion11 Feb 2008
Study completion15 Jan 2009

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.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289185
Sponsor's protocol ID: 104298
Other IDs: 2015-001539-19, 2015
Status last verified: Oct 2020
First submitted: 8 Feb 2006
Last updated: 29 Oct 2020
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.

Publications

Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F, Membi C, Omari S, Urassa A, Mshinda H, Jumanne A, Salim N, Shomari M, Aebi T, Schellenberg DM, Carter T, Villafana T, Demoitie MA, Dubois MC, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med. 2008 Dec 11;359(24):2533-44. doi: 10.1056/NEJMoa0807773. Epub 2008 Dec 8.
PubMed 19064623
Abdulla S, Salim N, Machera F, Kamata R, Juma O, Shomari M, Kubhoja S, Mohammed A, Mwangoka G, Aebi T, Mshinda H, Schellenberg D, Carter T, Villafana T, Dubois MC, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02(D) malaria vaccine in infants living in a malaria-endemic region. Malar J. 2013 Jan 8;12:11. doi: 10.1186/1475-2875-12-11.
PubMed 23297680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes DTPw/Hib in Infants Living in a Malaria-endemic Region.
ClinicalTrials.gov ID: NCT00289185
Acronym / sponsor ID: 104298
Conditions: Malaria, Malaria Vaccines
Keywords: Coccidiosis, Parasitic Diseases, Malaria, Falciparum, Malaria
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Sep 2006 (actual)
Primary completion: 11 Feb 2008 (actual)
Study completion: 15 Jan 2009 (actual)
First posted: 9 Feb 2006 (estimated)
Results: Posted 8 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Data pertaining to RTS,S/AS02D or Engerix-B will be collected in a double blinded manner; data relating to TETRActHib will be collected in an open fashion.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RTS,S/AS02D Group	Experimental	Biological: RTS,S/AS02D, Biological: TETRActHib™Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Engerix-B Group	Active comparator	Biological: Engerix-B®, Biological: TETRActHib™Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh..

Who may qualify

Ages: 6 to 10 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

A male or female infant between 6 and 10 weeks of age at the time of first vaccination.
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
Born to a mother who is HBsAg negative \& HIV negative.
Born after a normal gestation period (between 36 and 42 weeks).

Key exclusion criteria (16 listed)

Acute disease at the time of enrolment.
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Laboratory screening tests out of range for haemoglobin, total white cell count, platelets, ALT and creatinine.
Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines.
BCG administration within one week of proposed administration of a study vaccine.

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
RTS,S/AS02DAlso: GSK 257146, RTS, S/AS02D3-dose intramuscular injection in the thigh	Biological	RTS,S/AS02D Group
Engerix-B®3-dose intramuscular injection in the thigh.	Biological	Engerix-B Group
TETRActHib™Also: DTPw/Hib3-dose intramuscular injection in the thigh.	Biological	Engerix-B Group, RTS,S/AS02D Group

Primary outcome

Concentrations of Antibodies Against Hepatitis B (Anti-HB)
Time frame: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Week 0 to Month 9.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Concentrations of Antibodies Against Diphtheria (Anti-D)
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.
Concentrations of Antibodies Against Tetanus (Anti-T)
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.
Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 9 to Month 20.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Time frame: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value
Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.

9 secondary outcomes

Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies
Time frame: Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.
Number of Subjects With Solicited Local Symptoms.
Time frame: Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.
Number of Subjects With Solicited Local Symptoms.
Time frame: Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.
Number of Subjects With Solicited General Symptoms.
Time frame: Within 7 days (Days 0-6) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs).
Time frame: Within 30 days (Days 0-29) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the entire study, from Week 0 to Month 20.
Time to First Malaria Infection
Time frame: Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).
Number of Subjects Prevalent for Parasitemia
Time frame: At Month 9
Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia
Time frame: At Month 9

Results and safety

Results posted to the registry on 8 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Engerix-B Group	170	142
RTS,S/AS02D Group	170	144

Primary outcome: Concentrations of Antibodies Against Hepatitis B (Anti-HB)

Time frame: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.. Geometric mean (95% Confidence Interval). Unit: milli-international unit per milliliter

Measure	Engerix-B Group n = 148	RTS,S/AS02D Group n = 149
Anti-HB - PRE (N=134;116)	13.0 (9.8 to 17.2)	14.3 (10.8 to 19.0)
Anti-HB - Month 2 (N=148;149)	16.9 (13.5 to 21.2)	111.8 (89.9 to 139.0)
Anti-HB - Month 3 (N=141;141)	113.8 (91.3 to 141.8)	667.4 (533.8 to 834.4)

Population analysed: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs)

Time frame: From Week 0 to Month 9.. Number. Unit: Subject

Measure	Engerix-B Group n = 170	RTS,S/AS02D Group n = 170
Value	42	31

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Concentrations of Antibodies Against Diphtheria (Anti-D)

Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.. Geometric mean (95% Confidence Interval). Unit: international unit per milliliter

Measure	Engerix-B Group n = 165	RTS,S/AS02D Group n = 162
Anti-D - PRE (N=165;162)	NA (NA to NA)	NA (NA to NA)
Anti-D - Month 3 (N=151;149)	1.3 (1.1 to 1.5)	1.1 (1.0 to 1.3)

Primary outcome: Concentrations of Antibodies Against Tetanus (Anti-T)

Time frame: Prior to vaccination at Week 0 (PRE), and at Month 3.. Geometric mean (95% Confidence Interval). Unit: international unit per milliliter

Measure	Engerix-B Group n = 165	RTS,S/AS02D Group n = 162
Anti-T - PRE (N=165;162)	1.1 (0.9 to 1.4)	1.2 (1.0 to 1.6)
Anti-T - Month 3 (N=151;149)	4.2 (3.6 to 4.8)	3.0 (2.6 to 3.4)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engerix-B Group	62 of 170 (36.5%)	169 of 170 (99.4%)	Not reported
RTS,S/AS02D Group	57 of 170 (33.5%)	170 of 170 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19064623Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F, Membi C, Omari S, Urassa A, Mshinda H, Jumanne A, Salim N, Shomari M, Aebi T, Schellenberg DM, Carter T, Villafana T, Demoitie MA, Dubois MC, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N Engl J Med. 2008 Dec 11;359(24):2533-44. doi: 10.1056/NEJMoa0807773. Epub 2008 Dec 8.
Derived from this study: PubMed 23297680Abdulla S, Salim N, Machera F, Kamata R, Juma O, Shomari M, Kubhoja S, Mohammed A, Mwangoka G, Aebi T, Mshinda H, Schellenberg D, Carter T, Villafana T, Dubois MC, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02(D) malaria vaccine in infants living in a malaria-endemic region. Malar J. 2013 Jan 8;12:11. doi: 10.1186/1475-2875-12-11.
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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RTS,S/AS02D, Engerix-B® and TETRActHib™ in people with Malaria and Malaria Vaccines, run by GlaxoSmithKline at 1 site in Tanzania.

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 6 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 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Jul 2013). 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?

Concentrations of Antibodies Against Hepatitis B (Anti-HB) (time frame: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289185, which also lists 2 linked publications.

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 29 Oct 2020.