Phase 2
N=120
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT01262872 ↗Enrolled (actual)
120
Serious AEs
1.4%
Results posted
Apr 2014
Primary outcome: Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pneumococcal vaccine GSK 2189242A (LD formulation 1) (Biological); Pneumococcal vaccine GSK 2189242A (HD formulation 2) (Biological); Synflorix™ (Biological); Prevnar13™ (Biological); Tritanrix™-HepB/Hib (Biological); Polio Sabin™ (Biological); M-Vac™ (Biological); Stamaril™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects |
13; 7; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule |
154; 137; 145; 148; 149; 159 | — |
| PRIMARY Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule |
142; 152; 146; 160; 165; 162 | — |
| SECONDARY Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects |
0; 0; 0; 0; 60; 57 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects |
0; 0 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects |
22794.9; 8510.3; 31326.3; 16810.0 | — |
| SECONDARY Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects |
137.5; 65.1 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects |
1.71; 3.12; 4.80; 4.17; 1.17; 1.47 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects |
0.25; 2.35; 0.18; 1.36; 1.38; 5.51 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects |
— | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects |
17.2; 112.8; 2818.9; 4162.3; 9.0; 89.8 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects |
10.1; 152.5; 212.7; 8488.8; 461.7; 970.3 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects |
— | — |
| SECONDARY Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects |
682.3; 534.0 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
13968.86; 16771.16; 451.32; 419.47; 11268.35; 10817.78 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
11491.54; 488.79; 7453.65; 807.67; 17933.07; 1114.25 | — |
| SECONDARY Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
1922.8; 1833.8; 1990.2; 84.8; 559.2; 499.2 | — |
| SECONDARY Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
990.9; 1126.7; 281.3; 313.0; 534.8; 664.9 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule |
3.58; 3.20; 3.38; 5.51; 0.67; 0.55 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule |
2.52; 2.41; 0.44; 0.42; 1.65; 1.61 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule |
0.05; 0.05; 0.05; 4.52; 0.06; 0.06 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule |
0.04; 0.05; 0.06; 0.07; 0.07; 0.08 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule |
0.13; 0.13; 0.13; 3.01; 0.17; 0.15 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule |
0.11; 0.11; 0.10; 0.12; 0.14; 0.15 | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule |
— | — |
| SECONDARY Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule |
— | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
136.3; 62.7; 109.9; 161.4; 14.1; 10.1 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
67.3; 58.0; 7.7; 8.1; 58.8; 57.5 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
5.3; 4.5; 4.8; 98.3; 7.1; 5.5 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
4.7; 5.1; 5.9; 5.9; 7.4; 6.8 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
347.0; 281.1; 369.8; 2652.8; 120.4; 121.6 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
231.3; 177.4; 99.1; 107.4; 274.2; 361.2 | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
— | — |
| SECONDARY Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
— | — |
| SECONDARY Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
— | — |
| SECONDARY Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
— | — |
| SECONDARY Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
2.499; 2.696; 2.874; 1.531; 4.977; 5.113 | — |
| SECONDARY Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
2.591; 2.560; 5.714; 4.738 | — |
| SECONDARY Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
111.9; 110.3; 105.8; 117.0 | — |
| SECONDARY Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
123.2; 114.7 | — |
| SECONDARY Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
23.381; 19.397; 19.239; 18.981 | — |
| SECONDARY Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
21.274; 21.150 | — |
| SECONDARY Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
1235.8; 1165.8; 990.1; 1206.6 | — |
| SECONDARY Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
1318.5; 976.5 | — |
| SECONDARY Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
413.2; 314.8; 447.9; 398.3; 545.8; 619.5 | — |
| SECONDARY Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
330.3; 415.6; 486.7; 702.9; 106.9; 181.1 | — |
| SECONDARY Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
329.2; 298.6; 295.8; 274.1 | — |
| SECONDARY Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
284.5; 305.9 | — |
| SECONDARY Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
334.0; 264.7; 379.9; 306.7 | — |
| SECONDARY Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
342.0; 239.0 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule. |
108; 121; 123; 115; 0; 1 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. |
21; 26; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule. |
21; 26; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule |
43; 46; 38; 44; 0; 0 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule |
12; 4; 0; 0; 12; 4 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule |
12; 4; 0; 0; 12; 4 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule |
113; 114; 123; 114 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule |
7; 2 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule |
7; 2 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule |
1; 4; 3; 2 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule |
4; 5 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
165; 158; 166; 155; 166; 161 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
159; 162; 164; 173; 178; 176 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
24; 31; 34; 29; 25; 23 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
27; 24; 24; 23; 18; 19 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
57; 56; 60; 48; 54; 48 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
62; 50; 45; 49; 58; 52 | — |
| SECONDARY Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
29; 33; 28; 37; 27; 28 | — |
| SECONDARY Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
26; 23; 20; 32; 9; 11 | — |
| SECONDARY Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
88; 98; 104; 100; 72; 73 | — |
| SECONDARY Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
86; 93; 73; 84; 56; 83 | — |
| SECONDARY Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
5; 4; 5; 4; 4; 3 | — |
| SECONDARY Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
6; 4; 2; 4; 5; 2 | — |
| SECONDARY Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
44; 44; 54; 50; 36; 37 | — |
| SECONDARY Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
46; 62; 32; 40; 21; 17 | — |
| SECONDARY Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
124; 106; 120; 112; 108; 122 | — |
| SECONDARY Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
117; 128; 119; 138; 129; 117 | — |
| SECONDARY Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
136; 130; 142; 133; 128; 130 | — |
| SECONDARY Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
136; 141; 136; 155; 144; 131 | — |
| SECONDARY Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule |
17; 21; 16; 19; 24; 23 | — |
| SECONDARY Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule |
12; 12; 20; 25; 9; 8 | — |
Summary
This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Male or female between, and including,
- 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
- 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
- Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Permanent residence in the study area and no intention of leaving during the study period.
Additional inclusion criteria for subjects in Cohort 1:
- Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.
Exclusion Criteria
Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
- Child in care.
- Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
- 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
- Previous vaccination against S. pneumoniae.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Malnutrition
- A family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or any chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Contraindications to any co-administered vaccine.
- Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Additional exclusion criteria for subjects in Cohort 1:
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).
Data sourced from ClinicalTrials.gov (NCT01262872). 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.