Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa

This study has been completed.
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866619
First received: March 19, 2009
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.


Condition Intervention Phase
Malaria
Biological: Malaria Vaccine 257049
Biological: Meningococcal C Conjugate Vaccine
Biological: Cell-culture rabies vaccine
Biological: TritanrixHepB/Hib
Biological: Polio Sabin Oral Polio Vaccine (GSK)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • For a primary schedule, the occurrence of cases of malaria meeting the primary case definition for clinical malaria disease. [ Time Frame: Starting 14 days post Dose 3 for 12 months in children aged 6-12 weeks at the time of Dose 1, or until the time at which 450 subjects experience a case, whichever occurs later. ] [ Designated as safety issue: No ]
  • For a primary schedule, the occurrence of cases of malaria meeting the primary case definition for clinical malaria disease. [ Time Frame: Starting 14 days post Dose 3 for 12 months in children aged 5-17 months at the time of Dose 1, or until the time at which 450 subjects experience a case, whichever occurs later. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy against severe malaria disease: for a primary schedule (pooled with and without a boost), the occurrence of severe malaria disease meeting the primary and secondary case definitions. [ Time Frame: Timepoint at which 250 subjects are diagnosed with severe malaria meeting the primary case definition or at study end ] [ Designated as safety issue: No ]
  • Efficacy against severe malaria disease: for a primary schedule with and without a boost, the occurrence of severe malaria disease meeting the primary and secondary case definitions. [ Time Frame: Starting 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Efficacy against incident severe anemia and malaria hospitalization: for a primary schedule with and without a boost, the occurrence of incident severe anemia and malaria hospitalization meeting the primary and secondary case definitions. [ Time Frame: Starting 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Efficacy; duration of efficacy of a primary course: for a primary schedule without a boost, the occurrence of clinical malaria disease meeting the primary case definition [ Time Frame: Starting 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Efficacy; role of a booster: for a primary schedule with and without a boost, the occurrence of clinical malaria disease meeting the primary case definition. [ Time Frame: Starting at boost until study end ] [ Designated as safety issue: No ]
  • Efficacy under different transmission settings: for each site, for a primary schedule with and without a boost, the occurrence of clinical malaria disease meeting the primary case definition. [ Time Frame: Starting 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Efficacy against secondary case definitions of clinical malaria disease: for a primary schedule with and without a boost, the occurrence of clinical malaria disease meeting the secondary case definitions. [ Time Frame: Starting 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Efficacy against prevalence of parasitemia [ Time Frame: For a primary schedule without a boost, at 18 months and 30 months after a primary schedule. For a booster schedule, 12 months after a boost. ] [ Designated as safety issue: No ]
  • Efficacy against prevalence of moderate and severe anemia [ Time Frame: For a primary schedule without a boost, at 18 months and 30 months after a primary schedule. For a booster schedule, 12 months after a boost. ] [ Designated as safety issue: No ]
  • Safety of a primary course--SAEs (for each age category) [ Time Frame: For a primary schedule, SAEs from Dose 1 until 14 months post Dose 1. For a primary schedule without boost, SAEs starting at Dose 1 until boost, boost until study end and Dose 1 until study end. ] [ Designated as safety issue: No ]
  • Safety of a primary course--solicited symptoms (for each age category) [ Time Frame: For a primary schedule, over a 7-day follow-up period after each vaccination (on a subset). ] [ Designated as safety issue: No ]
  • Safety of a primary course--unsolicited symptoms related to vaccination or leading to withdrawal (for each age category) [ Time Frame: For a primary schedule, over a 30-day follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • Safety of a booster dose--SAEs (for each age category) [ Time Frame: Starting at, boost until study end. ] [ Designated as safety issue: No ]
  • Safety of a booster dose--solicited symptoms (for each age category) [ Time Frame: Over a 7-day follow-up period after the boost (on a subset). ] [ Designated as safety issue: No ]
  • Safety of a booster dose--unsolicited symptoms (for each age category) [ Time Frame: Over a 30 day follow-up period after boost ] [ Designated as safety issue: No ]
  • Immunogenicity of a primary course: anti-CS antibody titers (for each age category) [ Time Frame: At screening, 1 month post Dose 3, 18 months post Dose 3 and 30 months post Dose 3 (on a subset). ] [ Designated as safety issue: No ]
  • Immunogenicity of a primary course: anti-HBs antibody titers (for each age category) [ Time Frame: At screening, 1 month post Dose 3, 18 months post Dose 3 and 30 months post Dose 3 (on a subset). ] [ Designated as safety issue: No ]
  • Immunogenicity of a booster dose: anti-CS antibody titers (for each age category) [ Time Frame: At boost, 1 month post boost, 12 months post boost (on a subset). ] [ Designated as safety issue: No ]
  • Immunogenicity of a booster dose: anti-HBs antibody titers (for each age category) [ Time Frame: At boost, 1 month post boost, 12 months post boost (on a subset). ] [ Designated as safety issue: No ]
  • Immunogenicity of polio serotypes 1, 2 and 3: percentage of subjects with seroprotective levels of anti-polio 1, 2, 3 antibodies (in a subset of African children whose age at first dose will be 6-12 weeks) [ Time Frame: At one month post dose 3 ] [ Designated as safety issue: No ]
  • Immunogenicity of polio serotypes 1, 2 and 3: percentage of subjects with seroprotective levels of anti-polio 1, 2, 3 antibodies (in a subset of African children whose age at first dose will be 6-12 weeks) [ Time Frame: At one month post boost ] [ Designated as safety issue: No ]
  • Efficacy against other serious illness: the occurrence of other serious illness meeting the primary and secondary case definitions [ Time Frame: 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end. ] [ Designated as safety issue: No ]
  • Efficacy against fatal malaria and all-cause mortality: the occurrence of fatal malaria (meeting the case definitions) and all-cause mortality [ Time Frame: 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Effect on growth: to compare the height/length for age z-score [ Time Frame: From study start until study end ] [ Designated as safety issue: No ]
  • Effect on growth: to compare the weight for age z-score [ Time Frame: From study start until study end ] [ Designated as safety issue: No ]
  • Effect on growth: to compare the mid upper arm circumference for age z-score [ Time Frame: From study start until study end ] [ Designated as safety issue: No ]
  • Gender-specific efficacy: in male and female children, for a primary schedule with and without a boost the occurrence of clinical malaria disease meeting the primary case definition [ Time Frame: 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • Immunological correlates of protection: in cases and non-cases of malaria disease, CS-antibody titers. [ Time Frame: 14 days post Dose 3 until boost, boost until study end and 14 days post Dose 3 until study end ] [ Designated as safety issue: No ]
  • In HIV-infected children, for each age category, for a primary schedule with and without a boost, the occurrence of SAEs [ Time Frame: At Dose 1 until boost, boost until study end and Dose 1 until study end ] [ Designated as safety issue: No ]
  • In HIV-infected children, for each age category, for a primary schedule and a booster dose, the occurrence of unsolicited symptoms related to vaccination or leading to withdrawal [ Time Frame: Over a 30-day follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • In HIV-infected children, for each age category, for a primary schedule with and without a boost, the anti-CS antibody titers [ Time Frame: At screening, 1 month post Dose 3, 18 months post Dose 3 and 30 months post Dose 3 ] [ Designated as safety issue: No ]
  • In HIV-infected children for each age category, for a primary schedule with and without a boost, the anti-HBs antibody titers [ Time Frame: At screening, 1 month post Dose 3, 18 months post Dose 3 and 30 months post Dose 3 ] [ Designated as safety issue: No ]
  • In low weight for age children (weight for age z-score ≤-2) and in very low weight for age children (weight for age z-score ≤-3), for each age category, for a primary schedule with and without a boost, the occurrence of SAEs [ Time Frame: At Dose 1 until boost, boost until study end and Dose 1 until study end ] [ Designated as safety issue: No ]
  • In low weight for age children (weight for age z-score ≤-2) and in very low weight for age children (weight for age z-score ≤-3), for each age category, the occurrence of unsolicited symptoms related to vaccination or leading to withdrawal [ Time Frame: Over a 30-day follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • In low weight for age children (weight for age z-score ≤-2) and in very low weight for age children (weight for age z-score ≤-3), for each age category, for a primary schedule with and without a boost, the anti-CS antibody titers [ Time Frame: At screening, 1 month post Dose 3, 18 months post Dose 3 and 30 months post Dose 3. ] [ Designated as safety issue: No ]
  • In low weight for age children (weight for age z-score ≤-2) and in very low weight for age children (weight for age z-score ≤-3), for each age category, for a primary schedule with and without a boost, the anti-HBs antibody titers [ Time Frame: At screening, 1 month post Dose 3, 18 months post Dose 3 and 30 months post Dose 3 ] [ Designated as safety issue: No ]
  • In each of at least three study centers, the occurrence of clinical malaria disease meeting the primary and secondary case definitions for clinical malaria [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • Pooled across at least three study centers, the occurrence of clinical malaria disease meeting the primary and secondary case definitions for clinical malaria [ Time Frame: Over annual time periods (approximately 30 Jun 2012 to Jan 2014) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the occurrence of severe malaria disease meeting the primary and secondary case definitions for severe malaria [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the occurrence of malaria hospitalization meeting the primary and secondary case definitions for malaria hospitalization [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the presence of parasitemia [ Time Frame: At annual timepoints during the extension (approximately 30 Jun 2012 to Jan 2014) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the presence of moderate and severe anemia [ Time Frame: At annual timepoints during the extension (approximately 30 Jun 2012 to Jan 2014) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the occurrence of all-cause mortality and fatal malaria meeting the primary and secondary case definitions [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the occurrence of all-medical hospitalization meeting the primary case definition [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the occurrence of pneumonia meeting the primary and secondary case definitions [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • Pooled across all participating study centers, the occurrence of sepsis meeting the primary case definition [ Time Frame: Over a period starting 14 days post Dose 3 until the last visit of the extension (Visit 38) ] [ Designated as safety issue: No ]
  • In all participating study centers, the occurrence of SAEs [ Time Frame: From Dose 1 (Day 0) until the end of extension (Visit 38) ] [ Designated as safety issue: No ]
  • In a subset of subjects, the anti-CS antibody titers [ Time Frame: At annual timepoints during the extension (approximately 30 Jun 2012 to Jan 2014) ] [ Designated as safety issue: No ]
  • In all subjects at all participating study centers, to compare the height for age z-score [ Time Frame: At the end of extension (Visit 38) ] [ Designated as safety issue: No ]

Enrollment: 15460
Study Start Date: March 2009
Study Completion Date: January 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group R3R (children)
Children enrolled to this group will receive 3 doses of experimental malaria vaccine, and a booster dose of experimental malaria vaccine
Biological: Malaria Vaccine 257049
Vaccine, 0.5mL per dose
Active Comparator: Group R3C (children)
Children enrolled to this group will receive 3 doses of experimental malaria vaccine, and a booster dose of comparator vaccine
Biological: Malaria Vaccine 257049
Vaccine, 0.5mL per dose
Biological: Meningococcal C Conjugate Vaccine

Children enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [children] or C3C [children]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

Infants enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [infants] or C3C [infants]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

In addition, infants enrolled to receive a primary course comprising 3 doses of comparator vaccine (i.e. those enrolled to C3C [infants]) will get 3 doses of Meningococcal C Conjugate Vaccine.

Subjects will receive either Meningitec (Wyeth), NeisVac-C (Baxter) or Menjugate (Novartis). Note: where a subject is enrolled to receive 3 doses, each of the 3 doses will be from the same manufacturer

Active Comparator: Group C3C (children)
Children enrolled to this group will receive 3 doses of comparator vaccine, and a booster dose of comparator vaccine
Biological: Meningococcal C Conjugate Vaccine

Children enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [children] or C3C [children]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

Infants enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [infants] or C3C [infants]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

In addition, infants enrolled to receive a primary course comprising 3 doses of comparator vaccine (i.e. those enrolled to C3C [infants]) will get 3 doses of Meningococcal C Conjugate Vaccine.

Subjects will receive either Meningitec (Wyeth), NeisVac-C (Baxter) or Menjugate (Novartis). Note: where a subject is enrolled to receive 3 doses, each of the 3 doses will be from the same manufacturer

Biological: Cell-culture rabies vaccine
Children enrolled to receive a primary course comprising 3 doses of comparator vaccine (i.e. those enrolled to C3C [children]) will get 3 doses of cell-culture rabies vaccine. Subjects will receive either Human Diploid Cell Rabies Vaccine (Sanofi Pasteur) or Purified Chick Embryo Cell Culture Vaccine (i.e. Rabipur, or equivalent) (Novartis). Note: each of the 3 doses will be from the same manufacturer
Experimental: Group R3R (infants)
Infants enrolled to this group will receive 3 doses of experimental malaria vaccine, and a booster dose of experimental malaria vaccine
Biological: Malaria Vaccine 257049
Vaccine, 0.5mL per dose
Biological: TritanrixHepB/Hib

Diptheria, Tetanus, whole-cell Pertussis, Hemophilus influenzae (type B) Hepatitis B vaccine (0.5 mL dose).

All infants enrolled to the trial will receive 3 doses of TritanrixHebB/Hib, a standard EPI-compatible vaccine, commonly administered to infants in sub-Saharan Africa.

Biological: Polio Sabin Oral Polio Vaccine (GSK)
All infants enrolled to the trial will receive 3 doses of Polio Sabin Oral Polio Vaccine, a standard EPI-compatible vaccine, commonly administered to infants in sub-Saharan Africa
Experimental: Group R3C (infants)
Infants enrolled to this group will receive 3 doses of experimental malaria vaccine, and a booster dose of comparator vaccine
Biological: Malaria Vaccine 257049
Vaccine, 0.5mL per dose
Biological: Meningococcal C Conjugate Vaccine

Children enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [children] or C3C [children]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

Infants enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [infants] or C3C [infants]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

In addition, infants enrolled to receive a primary course comprising 3 doses of comparator vaccine (i.e. those enrolled to C3C [infants]) will get 3 doses of Meningococcal C Conjugate Vaccine.

Subjects will receive either Meningitec (Wyeth), NeisVac-C (Baxter) or Menjugate (Novartis). Note: where a subject is enrolled to receive 3 doses, each of the 3 doses will be from the same manufacturer

Biological: TritanrixHepB/Hib

Diptheria, Tetanus, whole-cell Pertussis, Hemophilus influenzae (type B) Hepatitis B vaccine (0.5 mL dose).

All infants enrolled to the trial will receive 3 doses of TritanrixHebB/Hib, a standard EPI-compatible vaccine, commonly administered to infants in sub-Saharan Africa.

Biological: Polio Sabin Oral Polio Vaccine (GSK)
All infants enrolled to the trial will receive 3 doses of Polio Sabin Oral Polio Vaccine, a standard EPI-compatible vaccine, commonly administered to infants in sub-Saharan Africa
Active Comparator: Group C3C (infants)
Infants enrolled to this group will receive 3 doses of comparator vaccine, and a booster dose of comparator vaccine
Biological: Meningococcal C Conjugate Vaccine

Children enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [children] or C3C [children]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

Infants enrolled to receive a comparator booster dose (i.e. those enrolled to R3C [infants] or C3C [infants]) will get 1 dose of Meningococcal C Conjugate Vaccine at the booster dose visit.

In addition, infants enrolled to receive a primary course comprising 3 doses of comparator vaccine (i.e. those enrolled to C3C [infants]) will get 3 doses of Meningococcal C Conjugate Vaccine.

Subjects will receive either Meningitec (Wyeth), NeisVac-C (Baxter) or Menjugate (Novartis). Note: where a subject is enrolled to receive 3 doses, each of the 3 doses will be from the same manufacturer

Biological: TritanrixHepB/Hib

Diptheria, Tetanus, whole-cell Pertussis, Hemophilus influenzae (type B) Hepatitis B vaccine (0.5 mL dose).

All infants enrolled to the trial will receive 3 doses of TritanrixHebB/Hib, a standard EPI-compatible vaccine, commonly administered to infants in sub-Saharan Africa.

Biological: Polio Sabin Oral Polio Vaccine (GSK)
All infants enrolled to the trial will receive 3 doses of Polio Sabin Oral Polio Vaccine, a standard EPI-compatible vaccine, commonly administered to infants in sub-Saharan Africa

Detailed Description:

The protocol posting document has been updated due to a protocol amendment dated 23 January 2012. An analysis time point has been added at Month 20. No changes have been made to the protocol endpoints or statistical methods but protocol endpoints will be analysed on data collected up to Month 20 once these data are available. The rationale is to have the full scope of protocol defined efficacy and safety endpoints related to a primary schedule without booster in both age categories followed up for 20 months earlier than at study end (Visit 34) as initially planned.

The protocol posting document was updated due to a protocol amendment dated 10 December 2010 to extend the study until December 2013 for all enrolled subjects (interval: Nov 2013-Jan 2014). Including the extension, the mean follow-up time for subjects from 5-17 months will be during 49 months post dose 1 (range: 41-55), while for subjects from 6-12 weeks, it will be during 41 months post dose 1 (range: 32-48). This study is double-blind during the first part and single-blind during the extension part. An analysis will be conducted at the end of the extension including an evaluation of safety and efficacy against clinical malaria, severe malaria and prevalent parasitemia.

  Eligibility

Ages Eligible for Study:   6 Weeks to 17 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

  • A male or female child of:5-17 months (inclusive) of age at time of first vaccination,or between 6-12 weeks of age at time of first vaccination and NOT have already received a dose of vaccine against diphtheria, tetanus or pertussis or Hemophilus influenzae type B and must be > 28 days of age at screening.
  • Signed informed consent 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.

All subjects must satisfy the following criteria at the start of the extension phase:

  • Subjects who were enrolled and who received at least one vaccine dose in the primary trial phase.
  • Subjects who were present for Visit 35 on or before 30 September 2013.
  • 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) should be enrolled in the study.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

  • Acute disease at the time of enrollment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
  • Anemia associated with clinical signs or symptoms of decompensation or hemoglobin ≥ 5.0 g/dL.
  • Major congenital defects.
  • History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations.
  • Children with a past history of a neurological disorder or atypical febrile seizure.
  • Children with malnutrition requiring hospital admission.
  • Children currently meeting the criteria for HIV disease of Stage III or Stage IV severity as defined by the World Health Organization.
  • History of allergic disease or reactions likely to be exacerbated by any component of the 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 a drug or vaccine that is not licensed for that indication with the exception of studies with the objective of improving the drug treatment or clinical management of severe malaria disease.
  • 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.
  • Previous participation in any other malaria vaccine trial.
  • Receipt of a vaccine within the preceding 7 days.
  • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
  • Any other findings that the investigator feels would result in data collected being incomplete or of poor quality
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866619

Locations
Burkina Faso
GSK Investigational Site
Ouagadougou, Burkina Faso
Gabon
GSK Investigational Site
Lambaréné, Gabon
Ghana
GSK Investigational Site
Kintampo, Ghana
GSK Investigational Site
Knust- Kumasi, Ghana
Kenya
GSK Investigational Site
Kilifi, Kenya, 80108
GSK Investigational Site
Kisumu, Kenya
Malawi
GSK Investigational Site
Lilongwe, Malawi
Mozambique
GSK Investigational Site
Maputo, Mozambique
Tanzania
GSK Investigational Site
Dar-es-Salaam, Tanzania
GSK Investigational Site
Tanga, Tanzania
Sponsors and Collaborators
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Abdulla S et al. Malaria Vaccine Candidate Phase III Evaluation: Efficacy Against Clinical and Severe Malaria, Safety and Immunogenicity profile in African Infants 6-12 Weeks of Age at first vaccination. Abstract presented at the International African Vaccinology Conference 2012 (IAVC), Cape Town, South Africa, 5-11 November 2012.
Tinto H et al. Efficacy, safety and immunogenicity of the RTS,S/AS01 candidate malaria vaccine in African children aged 5-17 months. Abstract presented at the 6th Congress of the West African Society of Parasitology (WASP), Dakar, Senegal. 18 - 20 Dec 2012.
Njuguna P et al. Malaria Vaccine Candidate Phase III Safety Evaluation in African Infants 6-12 Weeks of Age at First Vaccination Over 14 months of Follow-up. Abstract presented at the 61st Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), Atlanta, GA, 11-15 November 2012.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
RTS,S Clinical Trials Partnership, Agnandji ST, Lell B, Fernandes JF, Abossolo BP, Methogo BG, Kabwende AL, Adegnika AA, Mordmüller B, Issifou S, Kremsner PG, Sacarlal J, Aide P, Lanaspa M, Aponte JJ, Machevo S, Acacio S, Bulo H, Sigauque B, Macete E, Alonso P, Abdulla S, Salim N, Minja R, Mpina M, Ahmed S, Ali AM, Mtoro AT, Hamad AS, Mutani P, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Bihoun B, Guiraud I, Kaboré B, Sombié O, Guiguemdé RT, Ouédraogo JB, Hamel MJ, Kariuki S, Oneko M, Odero C, Otieno K, Awino N, McMorrow M, Muturi-Kioi V, Laserson KF, Slutsker L, Otieno W, Otieno L, Otsyula N, Gondi S, Otieno A, Owira V, Oguk E, Odongo G, Woods JB, Ogutu B, Njuguna P, Chilengi R, Akoo P, Kerubo C, Maingi C, Lang T, Olotu A, Bejon P, Marsh K, Mwambingu G, Owusu-Agyei S, Asante KP, Osei-Kwakye K, Boahen O, Dosoo D, Asante I, Adjei G, Kwara E, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Mahende C, Liheluka E, Malle L, Lemnge M, Theander TG, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng HO, Rettig T, Bawa J, Sylverken J, Sambian D, Sarfo A, Agyekum A, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Tembo T, Tegha G, Tsidya M, Kilembe J, Chawinga C, Ballou WR, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Olivier A, Vekemans J, Carter T, Kaslow D, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P. A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med. 2012 Dec 13;367(24):2284-95. doi: 10.1056/NEJMoa1208394. Epub 2012 Nov 9.
Agnandji ST, Lell B, Soulanoudjingar SS, Fernandes JF, Abossolo BP, Conzelmann C, Methogo BG, Doucka Y, Flamen A, Mordmüller B, Issifou S, Kremsner PG, Sacarlal J, Aide P, Lanaspa M, Aponte JJ, Nhamuave A, Quelhas D, Bassat Q, Mandjate S, Macete E, Alonso P, Abdulla S, Salim N, Juma O, Shomari M, Shubis K, Machera F, Hamad AS, Minja R, Mtoro A, Sykes A, Ahmed S, Urassa AM, Ali AM, Mwangoka G, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Tahita MC, Kaboré W, Ouédraogo S, Sandrine Y, Guiguemdé RT, Ouédraogo JB, Hamel MJ, Kariuki S, Odero C, Oneko M, Otieno K, Awino N, Omoto J, Williamson J, Muturi-Kioi V, Laserson KF, Slutsker L, Otieno W, Otieno L, Nekoye O, Gondi S, Otieno A, Ogutu B, Wasuna R, Owira V, Jones D, Onyango AA, Njuguna P, Chilengi R, Akoo P, Kerubo C, Gitaka J, Maingi C, Lang T, Olotu A, Tsofa B, Bejon P, Peshu N, Marsh K, Owusu-Agyei S, Asante KP, Osei-Kwakye K, Boahen O, Ayamba S, Kayan K, Owusu-Ofori R, Dosoo D, Asante I, Adjei G, Adjei G, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Kilavo H, Mahende C, Liheluka E, Lemnge M, Theander T, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng HO, Rettig T, Bawa J, Sylverken J, Sambian D, Agyekum A, Owusu L, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Msika A, Jumbe A, Chome N, Nyakuipa D, Chintedza J, Ballou WR, Bruls M, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Vekemans J, Carter T, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P; RTS,S Clinical Trials Partnership. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med. 2011 Nov 17;365(20):1863-75. doi: 10.1056/NEJMoa1102287. Epub 2011 Oct 18.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00866619     History of Changes
Other Study ID Numbers: 110021
Study First Received: March 19, 2009
Last Updated: February 20, 2014
Health Authority: Kenya: KEMRI (Kenya Medical Research Institute)
Burkina Faso: Comité d'éthique pour la recherche en santé au Burkina Faso (CNERS)
Gabon: Ministère de la Santé publique et de l'Hygiène publique
Ghana: Food and Drug Board
Mozambique: Comité Nacional de Bioética para Saùde (CNBS)
Tanzania: TFDA (Tanzania Food and Drugs Authority)
Malawi: Pharmacy, Medicines and Poisons Board

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 26, 2014