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Trial record 34 of 40 for:    "Yellow fever"

Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.

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ClinicalTrials.gov Identifier: NCT02699099
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.

Condition or disease Intervention/treatment Phase
Malaria Dietary Supplement: Vitamin A Biological: Candidate Plasmodium falciparum malaria vaccine Biological: MR-Vac Biological: Stamaril Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 721 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever Vaccines Followed by a Booster of the Malaria Vaccine.
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : March 14, 2018
Estimated Study Completion Date : December 18, 2020


Arm Intervention/treatment
Experimental: Coad group
Children randomized to receive Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and YF vaccine and a combined measles and rubella vaccine at 9 months of age. Children will receive a booster dose of SB257049 vaccine 18 months post Dose 3 (i.e. at 27 months of age)
Dietary Supplement: Vitamin A
Oral administration of Vitamin A (1 dose)

Biological: Candidate Plasmodium falciparum malaria vaccine
Intramuscular administration of SB257049 vaccine (4 doses)
Other Names:
  • RTS
  • S/AS01E

Biological: MR-Vac
Subcutaneous injection of a combined measles and rubella vaccine (1 dose)

Biological: Stamaril
Intramuscular injection of a yellow fever vaccine (1 dose)

Experimental: RTS,S group
Children randomized to receive Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and YF vaccine and a combined measles and rubella vaccine at 10.5 months of age. Children will receive a booster dose of SB257049 vaccine 18 months post Dose 3 (i.e. at 27 months of age)
Dietary Supplement: Vitamin A
Oral administration of Vitamin A (1 dose)

Biological: Candidate Plasmodium falciparum malaria vaccine
Intramuscular administration of SB257049 vaccine (4 doses)
Other Names:
  • RTS
  • S/AS01E

Biological: MR-Vac
Subcutaneous injection of a combined measles and rubella vaccine (1 dose)

Biological: Stamaril
Intramuscular injection of a yellow fever vaccine (1 dose)

Experimental: Control group
Children randomized to receive Vitamin A at 6 months of age and YF vaccine and a combined measles and rubella vaccine at 9 months of age. These children will receive SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age), so they can benefit from the same protection as children from the Coad and the RTS,S groups
Dietary Supplement: Vitamin A
Oral administration of Vitamin A (1 dose)

Biological: Candidate Plasmodium falciparum malaria vaccine
Intramuscular administration of SB257049 vaccine (4 doses)
Other Names:
  • RTS
  • S/AS01E

Biological: MR-Vac
Subcutaneous injection of a combined measles and rubella vaccine (1 dose)

Biological: Stamaril
Intramuscular injection of a yellow fever vaccine (1 dose)




Primary Outcome Measures :
  1. Anti-CS antibody titers [ Time Frame: At one month post vaccination (Month 4) ]
    Titers were expressed as Geometric Mean Titers (GMTs).


Secondary Outcome Measures :
  1. Anti-CS and anti-HBs antibody titers and seropositivity [ Time Frame: At Screening (Day 0) and one month post-vaccination (Month 4) ]
    Titers were expressed as Geometric Mean Titers (GMTs). A subject seropositive for anti-CS antibody will be a subject whose antibody titer will be greater than or equal to the cut-off value (anti-CS≥0.5 EU/ml).

  2. Seroconversion for anti-Measles antibodies [ Time Frame: At one month post-vaccination (Month 4) ]
    Seroconversion is defined as number of subjects with an anti-Measles antibodies pre-vaccination titer below 150 mIU/ml and a post-vaccination titer ≥150 mIU/ml. Seroconversion was assessed in the Control group and the Coad group.

  3. Anti-Measles antibody titers and seropositivity [ Time Frame: At pre-vaccination (Month 3) and one month post-vaccination (Month 4) ]
    Anti-Measles antibody titers and seropositivity (≥ 150 mIU/ml) were assessed in the Control group and the Coad group.

  4. Seroconversion for anti-Rubella antibodies [ Time Frame: At one month post-vaccination (Month 4) ]
    Seroconversion is defined as number of subjects with an anti-Rubella pre-vaccination titer below 4 IU/ml and a post-vaccination titer ≥ 4 IU/ml. Seroconversion was assessed in the Control group and Coad group.

  5. Anti-Rubella antibody titers and seropositivity [ Time Frame: At pre-vaccination (Month 3) and one month post-vaccination (Month 4) ]
    Anti-Rubella antibody titers and seropositivity (≥ 4 IU/ml) were assessed in the Control group and Coad group.

  6. Anti-YF antibody titers and seropositivity [ Time Frame: At one month post-vaccination with the YF vaccine (Month 4) ]
    Seropositivity (≥10 ED50) for anti-YF was assessed in the Control group and Coad group.

  7. Solicited local and general AEs [ Time Frame: During the 7-day period (day 0-6) after Visit 2 (6 months of age) and after Visit 3 (7.5 months of age) and the 14-day period (day 0-13) after Visit 4 (9 months of age) ]
    Solicited local and general symptoms assessed will be pain, irritability/fussiness, drowsiness, loss of appetite and rash.

  8. Unsolicited adverse events (AEs) [ Time Frame: During the 30-day period (day 0-29) after Visits 2 and 3 (at 6 and 7.5 month of age), the 42-day period (day 0-41) after Visit 4 (9 months of age) ]
    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.

  9. Unsolicited adverse events(AEs) [ Time Frame: For Coad and RTS,S groups during the 30-day period (day 0-29) after Visit 10 (27 months of age), and for Control group, during the 30-day period (day 0-29) after Visits 6, 7, 8 and 12 (at 10.5, 11.5, 12.5 and 30 months of age10.5, 11.5, 12.5 and 30 month ]
    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.

  10. Occurrence of any, fatal and related serious adverse events (SAEs) [ Time Frame: From Screening visit (Day 0) until Month 4.5 and until study end (Month 33 for Coad and RTS,S groups and Month 36 for the Control group) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  11. Occurrence of any, fatal and related SAEs [ Time Frame: Within 30 days (day 0-29) after each administrations 10 Within 30 days (day 0-29) after each administrations 10 From Screening visit until Month 4.5 and until study end. ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  12. Occurrence of pIMDs [ Time Frame: From Day 0 until Month 4.5 and until study end (Month 33 for Coad and RTS,S groups and Month 36 for the Control group) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

  13. Occurrence of meningitis [ Time Frame: From Day 0 until Month 4.5 and until study end (Month 33 for Coad and RTS,S groups and Month 36 for the Control group) ]
    All occurrences of meningitis occurring during the study will be reported.

  14. Occurrence of seizure [ Time Frame: Within 30 days post-vaccination for vaccine doses administered at 6 and 7.5 months of age [Visits 2 and 3] or 42 days post-vaccination for vaccine doses administered at 9 months of age [Visit 4] from Day 0 until Month 4.5 ]
    All seizures occurring will be reported.

  15. Occurrence of seizures [ Time Frame: Within 30 days post-vaccination for vaccine doses administered at 6, 7.5 and 27 months of age (Visits 2, 3 and 10 for Coad and RTS,S group) and at 10.5, 11.5, 12.5 and 30 months of age (Visits 6, 7, 8 and 12 for Control group) or 42 days post-vaccination ]
    All seizures occurring will be reported

  16. Occurrence of generalized convulsive seizure [ Time Frame: Within 7 days after vaccines administered at Visit 2 and 3 (Coad and RTS,S groups) and 14 days after vaccines administered at Visit 4 (all groups) ]
    All generalized convulsive seizures occurring will be reported.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects' parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female 6 months of age (from the day the child becomes 6 months of age until the day before the child achieves 7 months of age) at the time of the first vaccination.
  • Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously received three documented doses of diphtheria, tetanus, and whole-cell pertussis, hepatitis B vaccine (DTPwHepB), and a 3-dose course of oral polio vaccine and, if locally recommended, pneumococcal and rotavirus vaccines.

Exclusion Criteria:

  • Child in care
  • 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.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose of SB257049 measles, rubella and YF vaccines and ending 42 days after the last dose of vaccines given at 9 months of age (Visit 4), with the exception of oral polio vaccine which could be given for unforseen public health threat.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
  • Previous vaccination against measles, YF or rubella.
  • Previous administration of Vitamin A.
  • Moderate or severe malnutrition at screening defined as weight for age Z-score < -2.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). See also Section 1.3.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be axillary.

Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.

  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Same sex twin.
  • Maternal death.
  • Previous participation in any other malaria study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699099


Locations
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Ghana
GSK Investigational Site
Kintampo, Ghana
GSK Investigational Site
Kumasi, Ghana
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02699099     History of Changes
Other Study ID Numbers: 200596
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Children
Infants
SB257049
Malaria
Immunogenicity
Surveillance
Efficacy
Safety
Africa
Plasmodium falciparum

Additional relevant MeSH terms:
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Yellow Fever
Malaria
Rubella
Protozoan Infections
Parasitic Diseases
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
Hemorrhagic Fevers, Viral
Vaccines
Vitamins
Vitamin A
Retinol palmitate
Immunologic Factors
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents