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

Browse trials for

• Malaria 1,299

Keywords

• Malaria
• Plasmodium falciparum

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 327 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  GSK 257049-Lot 1 Group

  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)

• Experimental
  GSK 257049-Lot 2 Group

  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)

• Experimental
  GSK 257049-Lot 3 Group

  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)

• Experimental
  GSK 257049-Pilot Group

  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

• BiologicalGSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

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

Primary outcomes

1. Anti-Circumsporozoite (Anti-CS) Antibody Titers

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

   Time frame: One month post-dose 3 (Month 3)

Secondary outcomes

1. Anti-hepatitis B (Anti-HB) Antibody Concentrations

   Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

   Time frame: One month post-dose 3 (Month 3)

2. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

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

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

   Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

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

4. Number of Subjects With Unsolicited Adverse Events

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

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

5. Number of Subjects With Serious Adverse Events

   Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

   Time frame: Up to 8 months post-dose 1

Baseline characteristics

Related links

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Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.