Phase 3
N=41,181
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Infections, Streptococcal · Streptococcus Pneumoniae
Bottom Line
View on ClinicalTrials.gov: NCT00861380 ↗Enrolled (actual)
41,181
Serious AEs
0.1%
Results posted
Sep 2020
Primary outcome: Primary: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course — 0.000; 0.564 Participants per 1000 person-years — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pneumococcal conjugate vaccine GSK1024850A (Biological); GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) (Biological); GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course |
0.000; 0.564 | <0.0001 sig |
| PRIMARY Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course |
0.048; 0.564 | = 0.0009 sig |
| SECONDARY Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Till End of Blinded ID FU Period) |
0.093; 0.845; 0.000; 0.657; 0.000; 0.000 | — |
| SECONDARY Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Till End of Blinded ID FU Period) |
0.194; 0.845; 0.097; 0.657; 0.048; 0.564 | — |
| SECONDARY Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule |
0.000; 0.446; 0.000; 0.446; 0.000; 0.446 | — |
| SECONDARY Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population) |
0.000; 0.674; 0.000; 0.674; 0.000; 0.404 | — |
| SECONDARY Person Year Rate in the Prevention of Probable Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course |
0.000; 0.141; 0.000; 0.798 | — |
| SECONDARY Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course |
0.000; 0.141; 0.097; 0.798 | — |
| SECONDARY Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule |
0.000; 0.000; 0.000; 0.446 | — |
| SECONDARY Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population) |
0.000; 0.000; 0.000; 0.674 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course |
10.131; 13.854 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course |
10.155; 13.854 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination in the 7-11 Months Schedule |
10.263; 15.752 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population) |
9.322; 11.739 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course |
2.181; 3.965; 2.908; 2.937; 5.090; 6.903 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course |
2.273; 3.965; 2.627; 2.937; 4.901; 6.903 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule |
1.960; 4.401; 3.344; 4.865; 5.305; 9.266 | — |
| SECONDARY Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule |
1.824; 3.494; 2.837; 2.935; 4.661; 6.428 | — |
| SECONDARY Person Year Rate in Prevention of All Tympanostomy Tube Placements- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course |
68.735; 79.504 | — |
| SECONDARY Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course |
66.083; 79.504 | — |
| SECONDARY Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 7-11 Months Schedule |
68.153; 79.920 | — |
| SECONDARY Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population) |
56.809; 58.973 | — |
| SECONDARY Person Year Rate in Prevention of All Antimicrobial Prescriptions- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course |
1592.585; 1706.194; 1451.141; 1565.692 | — |
| SECONDARY Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course |
1552.493; 1706.194; 1415.983; 1565.692 | — |
| SECONDARY Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 7-11 Months Schedule |
1536.618; 1649.360; 1390.856; 1499.713 | — |
| SECONDARY Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 12-18 Months Schedule (+ Indirect Effects on the Unvaccinated Population) |
1315.936; 1421.774; 1177.729; 1271.268 | — |
| SECONDARY Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course |
0; 1; 0; 1; 0; 3 | — |
| SECONDARY Number of Subjects With Lower Respiratory Tract Infections (LRTIs) (in a Subset of Subjects in Turku Area) |
19; 19; 19; 3; 1; 5 | — |
| SECONDARY Number of Subjects With Upper Respiratory Tract Infections (URTIs) (in a Subset of Subjects in Turku Area) |
158; 124; 94; 14; 15; 27 | — |
| SECONDARY Number of Subjects With SAEs Reported During the Blinded Invasive Disease Phase, of the Study |
6; 7; 8; 3; 2; 2 | — |
| SECONDARY Number of Subjects Enrolled and Vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 Study With Post-study SAEs Reported Via Passive Surveillance- Subjects Enrolled Aged 6 Weeks to 6 Months and 7 to 18 Months |
1; 2; 0; 0; 0; 0 | — |
| SECONDARY Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period |
0.046; 0.268; 0.023; 0.210; 0.0; 0.140 | — |
| SECONDARY Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period |
0.047; 0.268; 0.024; 0.21; 0.012; 0.140 | — |
Summary
The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions.
This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.
Eligibility Criteria
Inclusion Criteria
- Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
- Written informed consent obtained from parent(s) or from the guardian(s) of the subject.
Exclusion Criteria
- Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use during the study period. If a child belongs to a high risk group for pneumococcal infections for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
- Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
- Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
- Known severe hypersensitivity to any component of the study vaccines, including neomycin.
- Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Data sourced from ClinicalTrials.gov (NCT00861380). 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.