Primary immunization against Plasmodium falciparum malaria in healthy male and female infants aged 6 to 10 weeks at first vaccine dose, if eligible according to inclusion and exclusion criteria.
Conditions
Interventions
Product Name: Candidate Plasmodium falciparum malaria vaccine
Product Code: RTS,S+AS01E
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: -
Current Sponsor
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -A male or female infant between 6 and 10 weeks of age at the time of first vaccination. -Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. -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. -Subjects who have received one previous dose of OPV and BCG. -Subjects who are born after a normal gestation period (between 36 and 42 weeks). Are the trial subjects under 18? yes Number of subjects for this age range: 511 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -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, specifically: ALT and creatinine above acceptable limit; Hemoglobin, Platelet count and Total white cell count below acceptable limit. -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. -OPV administration within four weeks of proposed administra-tion 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). -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 since birth to the first dose of study vaccine or planned administration during the study period. -Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. -Simultaneous participation in any other clinical trial. -Twins (to avoid misidentification). -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the safety (SAEs) of RTS,S/AS01E when co-administered on a 0, 1, 2-month schedule with DTPwHepB/Hib and OPV at 6, 10 and 14 weeks of age, until 5 months post Dose 3 of RTS,S/AS01E (study Month 8), and when co-administered on a 0, 1, 7-month schedule with DTPwHepB/Hib and OPV at 6 and 10 weeks of age then with measles and yellow fever vaccination at 9 months of age, until one month post Dose 3 of RTS,S/AS01E (study Month 8).;Secondary Objective: -To describe the safety (AEs) of RTS,S/AS01E during 1 month after each vaccination and the reactogenicity of RTS,S/AS01E during 7 days after each vaccination for different schedules. - To describe antibody responses to D, T, Pw, Hib, HBs, polio serotype 1, polio serotype 2, polio serotype 3, measles and yellow fever antigens for different schedules. -To describe the antibody response to CS and HBs antigens for different schedules. -To demonstrate the non-inferiority of antibody responses to D, T, Pw, Hib, HBs, polio serotype 1, polio serotype 2, polio sero-type 3, measles and yellow fever antigens for different schedules.;Primary end point(s): Occurrence of SAEs;Timepoint(s) of evaluation of this end point: From the time of first vaccination until 8 months post first study vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Occurrence of unsolicited AEs 2) Occurrence of solicited general and local reactions 3) Immunogenicity assessed for the 0, 1, 2-month RTS,S/AS01E schedule and in control: anti-HBs antibody titers, anti-diphteria antibody titers, anti-tetanus antibody titers, anti-PRP antibody titers, anti-BPT antibody titers, and anti-polio type 1, 2 and 3 antibody titers. 4) Immunogenicity assessed for the 0, 1, 7-month RTS,S/AS01E schedule and in control: anti-HBs antibody titers, anti-diphteria antibody titers, anti-tetanus antibody titers, anti-PRP antibody titers, anti-BPT antibody titers, and anti-polio type 1, 2 and 3 antibody titers 5) Immunogenicity assessed for the 0, 1, 7-month RTS,S/AS01E schedule and in control: anti-measles antibody titers and anti-yellow fever antibody titers 6) Immunogenicity assessed in the control group: anti-HBs and anti-CS antibody titers 7) Immunogenicity assessed in the 0, 1, 2-month RTS,S/AS01E schedule: anti-HBs and anti-CS antibody titers 8) Immunogenicity assessed in the 0, 1, 7-month RTS,S/AS01E schedule: anti-HBs and anti-CS antibody titers 9) Difference between groups in percent seroprotection to HBs, diphtheria, tetanus, PRP, polio virus types 1, 2 and 3, and in percent seroconversion to measles and yellow fever ;Timepoint(s) of evaluation of this end point: 1) After study vaccination over a 30-day follow-up period (day of vaccination and 29 subsequent days) 2) Over a 7-day follow-up period (day of vaccination and 6 subsequent days) after study vaccination 3) One month post Dose 3 of DTPwHepB/Hib and OPV 4) One month post Dose 3 of DTPwHepB/Hib and OPV 5) One month post measles and yellow fever vaccination 6) Prior to first study vaccination and 3, 7 and 8 months post first study vaccination 7) Prior to first study vaccination and 2, 3 and 7 months post first study vaccination 8) Prior to first study vaccination and 3, 7 and 8 months post first study vaccination 9) One month post last dose | — |
Countries
Gabon, Ghana, Tanzania, United Republic of
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed