Phase 3
N=300
Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT01175083 ↗Enrolled (actual)
300
Serious AEs
7.7%
Results posted
Jun 2019
Primary outcome: Primary: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines — 3.51; 3.63; 4.25; 3.51 µg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK1024850A (Synflorix) (Biological); Tritanrix-HepB/Hib (Biological); Polio Sabin (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
3.51; 3.63; 4.25; 3.51; 5.15; 5.94 | — |
| PRIMARY Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
2789.09; 3065.40 | — |
| SECONDARY Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
0.09; 0.09; 0.67; 0.69; 5.34; 5.14 | — |
| SECONDARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose |
0.03; 0.04; 5.48; 3.99; 2.68; 2.44 | — |
| SECONDARY Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose |
0.04; 0.04; 1.39; 1.49; 4.67; 4.26 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
0.10; 0.15; 0.12; 0.10; 0.40; 0.18 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose |
0.03; 0.03; 0.18; 0.16; 0.23; 0.22 | — |
| SECONDARY Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose |
0.03; 0.04; 0.15; 0.12; 0.39; 0.31 | — |
| SECONDARY Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
64.75; 70.97; 859.87; 840.88; 2871.72; 3137.87 | — |
| SECONDARY Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose |
72.73; 88.74; 1313.39; 1489.78; 932.52; 1063.54 | — |
| SECONDARY Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose |
79.59; 76.22; 199.23; 184.34; 1376.56; 760.99 | — |
| SECONDARY Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
106.4; 94.6; 11.7; 10.9; 930.5; 750.4 | — |
| SECONDARY Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose |
4.9; 4.5; 134.7; 88.1; 74.2; 48.0 | — |
| SECONDARY Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose |
6.9; 5.6; 9.3; 10.9; 195.7; 115.1 | — |
| SECONDARY Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines |
24.73; 9.45; 18.23; 17.59; 35.35; 30.70 | — |
| SECONDARY Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose |
4.81; 5.02; 40.59; 51.23; 38.11; 36.27 | — |
| SECONDARY Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose |
9.26; 6.35; 82.82; 77.25; 147.91; 157.37 | — |
| SECONDARY Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine |
0.07; 0.06; 3.22; 3.50; 0.62; 0.90 | — |
| SECONDARY Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine |
7.71; 7.77; 105.61; 101.74; 22.67; 22.69 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase |
8; 12; 7; 10; 9; 6 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase |
11; 6; 3; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
37; 34; 32; 37; 23; 25 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
3; 9; 3; 4; 2; 2 | — |
Summary
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- A male or female between, and including:
- 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or
- 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or
- 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
- Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (<6S group) or electrophoresis (7-11S and 12-23S groups).
- Free of any other 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
Additional inclusion criteria for healthy children (<6NS, 7-11NS and 12-23NS groups):
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Children with negative diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.
Exclusion Criteria
- Child in care
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. 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 during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
- 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).
- Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital malformations.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Birth weight below 1500g.
- Serious chronic illness other than SCD.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
- Subje
Data sourced from ClinicalTrials.gov (NCT01175083). 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.