Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
NCT ID: NCT01231503
Last Updated: 2018-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
480 participants
INTERVENTIONAL
2011-01-13
2014-12-23
Brief Summary
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* Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
* Investigate how to maximize the antibody response to the experimental malaria vaccine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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RTS,S Neo-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
RTS,S Neo-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanri xHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
RTS,S 6-10-14 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
RTS,S 6-10-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Engerix-B Neo/RTS,S 6-10-26 Group
Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Engerix-B
1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
RTS,S 10-14-26 Group
Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
RTS,S 14-26-9M Group
Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Engerix-B Neo Group
Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
Engerix-B
1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Interventions
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GSK Biological's Investigational Malaria Vaccine 257049
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
Engerix-B
1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)
Tritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
OPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
Rouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth).
* 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.
* Born to a mother negative for HIV antibody and Hepatitis B surface antigen.
* Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life).
* A minimum weight of 2.5 kg.
Exclusion Criteria
* Acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to:
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects.
* History of any neurological disorders or seizures.
* Laboratory screening tests out of normal ranges/limits defined per protocol.
* Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vaccines.
* Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) not foreseen by the study protocol within 7 days of the first dose of study vaccine.
* 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.
* Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) other than the study vaccine starting at birth or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Simultaneous participation in any other clinical trial.
* Same-sex 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.
* Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
1 Day
7 Days
ALL
Yes
Sponsors
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The PATH Malaria Vaccine Initiative (MVI)
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Bangwe, Blantyre, , Malawi
Countries
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References
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Witte D, Cunliffe NA, Turner AM, Ngulube E, Ofori-Anyinam O, Vekemans J, Chimpeni P, Lievens M, Wilson TP, Njiram'madzi J, Mendoza YG, Leach A. Safety and Immunogenicity of Seven Dosing Regimens of the Candidate RTS,S/AS01E Malaria Vaccine Integrated Within an Expanded Program on Immunization Regimen: A Phase II, Single-Center, Open, Controlled Trial in Infants in Malawi. Pediatr Infect Dis J. 2018 May;37(5):483-491. doi: 10.1097/INF.0000000000001937.
Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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111315
Identifier Type: -
Identifier Source: org_study_id
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