Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children

NCT01323972 | Completed Phase 3 Results

• 1 other identifier: 113398
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.

Conditions

Malaria

Keywords

Malaria; Plasmodium falciparum

Outcome Measures

Primary Outcomes (1)

• Anti-Circumsporozoite (Anti-CS) Antibody Titers

  Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

  One month post-dose 3 (Month 3)

Secondary Outcomes (5)

• Anti-hepatitis B (Anti-HB) Antibody Concentrations

  One month post-dose 3 (Month 3)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses

• Number of Subjects With Unsolicited Adverse Events

  Within the 30-day (Days 0-29) post-vaccination period

• Number of Subjects With Serious Adverse Events

  Up to 8 months post-dose 1

Study Arms (4)

GSK 257049-Lot 1 Group

EXPERIMENTAL

Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

GSK 257049-Lot 2 Group

EXPERIMENTAL

Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

GSK 257049-Lot 3 Group

EXPERIMENTAL

Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

GSK 257049-Pilot Group

EXPERIMENTAL

Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

Interventions

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) BIOLOGICAL

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

GSK 257049-Lot 1 Group; GSK 257049-Lot 2 Group; GSK 257049-Lot 3 Group; GSK 257049-Pilot Group

Eligibility Criteria

• Age: 5 Months - 17 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• A male or female child between, and including, 5 and 17 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 child. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who have received three documented doses of hepatitis B vaccine.

You may not qualify if:

• Same sex twins.
• 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.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2.
• Acute disease and/or fever at the time of enrolment
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
• 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.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a licensed vaccine not foreseen by the study protocol within 7 days of the first dose of study 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 an investigational or a non-investigational product.
• Administration of immunoglobulins and/or any blood products within 1 month preceding the first dose of study vaccine or planned administration during the study period.
• Child in care.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• The PATH Malaria Vaccine Initiative (MVI): collaborator

Study Sites (2)

GSK Investigational Site

Enugu, Nigeria

Location

GSK Investigational Site

Jos, Nigeria

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 28, 2011
• Study Start: May 16, 2011
• Primary Completion: November 22, 2011
• Study Completion: May 4, 2012
• Last Updated: August 17, 2018
• Results First Posted: August 7, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

NG (2)