Safety and immunogenicity study of GSK Biologicals' malaria vaccine 257049, when incorporated into an EPI regimen.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-005695-34-Outside-EU/EEA
• Date of registration: 17/06/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Safety and immunogenicity study of GSK Biologicals' malaria vaccine 257049, when incorporated into an EPI regimen.
• Scientific title: A Phase II randomized, open, controlled study of the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate Plasmodium falciparum malaria vaccine RTS,S/AS01E, when incorporated into an Expanded Program on Immunization (EPI) regimen that includes DTPwHepB/Hib, OPV, measles and yellow fever vaccination in infants living in malaria-endemic regions. - MALARIA-050
• Target sample size: 511
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005695-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: In Control group, all co-ads the same as other 2 groups, but no inv prod administered Number of treatment arms in the trial: 3

Countries of recruitment

Gabon, Ghana, Tanzania, United Republic of

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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:
-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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.

Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

Intervention(s)

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 code: RTS,S
Other descriptive name: RTS,S
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Trade Name: Tritanrix HepB
Product Code: DTPw-HBV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: -
Current Sponsor code: T
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 60-
INN or Proposed INN: -
Current Sponsor code: Pw
Other descriptive name: WHOLE-CELL BORDETELLA PERTUSSIS (INACTIVATED)
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 4-
INN or Proposed INN: -
Current Sponsor code: HBsAg
Other descriptive name: HEPATITIS B SURFACE ANTIGEN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Trade Name: Polio Sabin (Oral)
Product Code: OPV
Pharmaceutical Form: Oral suspension
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS TYPE 1, STRAIN LSC, 2AB
Concentration unit: log10 CCID50 log10 cell culture infective dose 50
Concentration type: not less then
Concentration number: 6.0-
INN or Proposed INN: -
Other descriptive name: POLIOVIRUS TYPE 3, STRAIN LEON 12A, 1B
Concentration unit: log10 CCID50 log10 cell culture infective dose 50
Concentration type: not less then
Concentration number: 5.8-
INN or Proposed INN: -

Primary Outcome(s)

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.

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).

Timepoint(s) of evaluation of this end point: From the time of first vaccination until 8 months post first study vaccination.

Primary end point(s): Occurrence of SAEs

Secondary Outcome(s)

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

Secondary ID(s)

106369

Source(s) of Monetary Support

GlaxoSmithKline Biologicals

Malaria Vaccine Initiative