Phase 3
N=357
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00678301 ↗Enrolled (actual)
357
Serious AEs
1.4%
Results posted
Oct 2017
Primary outcome: Primary: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes — 2.69; 0.03; 3.44; 0.03 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK Biologicals' Synflorix™ (Biological); GSK Biologicals' Polio Sabin™ (Biological); GSK Biologicals' Zilbrix™ Hib (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes |
2.69; 0.03; 3.44; 0.03; 4.17; 0.03 | — |
| PRIMARY Antibody Concentrations Against Protein D (Anti-PD Antibodies) |
3791.8; 85.4 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) |
0.09; 0.04; 0.15; 0.06 | — |
| SECONDARY Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes |
83; 5; 892.5; 4.6; 82.7; 4.5 | — |
| SECONDARY Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes |
14.1; 6.1; 11; 4.3 | — |
| SECONDARY Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes |
217; 14; 217; 12; 217; 18 | — |
| SECONDARY Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes |
217; 2; 217; 3; 217; 4 | — |
| SECONDARY Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) |
152; 36; 176; 49 | — |
| SECONDARY Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A) |
56; 8; 95; 15 | — |
| SECONDARY Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies) |
217; 34 | — |
| SECONDARY Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes |
92; 3; 105; 3; 100; 2 | — |
| SECONDARY Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes |
31; 6; 39; 3 | — |
| SECONDARY Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations |
111.9; 124.9 | — |
| SECONDARY Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT) |
110; 111 | — |
| SECONDARY Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations |
4.103; 3.13; 6.484; 4.588 | — |
| SECONDARY Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens |
110; 112; 110; 112 | — |
| SECONDARY Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations |
18.461; 10.137 | — |
| SECONDARY Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) |
110; 111 | — |
| SECONDARY Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens |
107; 102 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations |
1835.1; 1485.5 | — |
| SECONDARY Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs). |
89; 96; 89; 94 | — |
| SECONDARY Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms |
234; 112; 8; 3; 57; 30 | — |
| SECONDARY Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms |
24; 12; 0; 0; 207; 105 | — |
| SECONDARY Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off |
40; 13 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
176; 92 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
5; 0 | — |
Summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
- History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
- Babies for which birth weight is < 2 kilogram (if known) at Visit 1
Data sourced from ClinicalTrials.gov (NCT00678301). 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.