Phase 3
N=1,112
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00370396 ↗Enrolled (actual)
1,112
Serious AEs
5.1%
Results posted
Nov 2018
Primary outcome: Primary: Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups — 24; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Synflorix (Biological); Prevenar (Biological); Infanrix hexa (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups |
24; 7 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
452; 48; 150; 47; 3; 18 | — |
| SECONDARY Number of Subjects With Any and Any Grade 3 Solicited General Symptoms |
303; 48; 130; 5; 0; 5 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
188; 32; 99 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study |
12; 1; 4 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study |
33; 6; 8 | — |
| SECONDARY Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) |
123; 3; 3; 340; 4; 113 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) |
0.14; 0.03; 0.03; 1.53; 0.04; 0.67 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
6.1; 5; 4.9; 192.2; 4.3; 8.3 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) |
556.4; 72.3; 78.1; 2887.6; 75.3; 125.5 | — |
| SECONDARY Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations |
0.308; 0.231; 0.246; 36.634; 25.731; 29.851 | — |
| SECONDARY Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations |
5.5; 7.3; 7; 79.6; 76; 85.8 | — |
| SECONDARY Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations |
0.179; 0.291; 0.29; 5.809; 6.272; 9.337 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations |
147.2; 148.9; 156.6; 3869.1; 3132.2; 4358.6 | — |
| SECONDARY Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers |
25.3; 21.2; 27.1; 904.4; 819.3; 1003.7 | — |
| SECONDARY Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens |
323; 31; 132; 332; 31; 129 | — |
Summary
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.
The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.
Eligibility Criteria
Inclusion Criteria
- a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject.
Exclusion Criteria
- use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
- Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.
Data sourced from ClinicalTrials.gov (NCT00370396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.