Phase 3
N=351
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00307034 ↗Enrolled (actual)
351
Serious AEs
3.4%
Results posted
Apr 2017
Primary outcome: Primary: Number of Seroprotected Subjects Against Pneumococcal Serotypes — 149; 149; 150; 152 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK Biologicals' 10-valent pneumococcal conjugate vaccine. (Biological); Infanrix hexa. (Biological); Infanrix-IPV/Hib. (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Pneumococcal Serotypes |
77; 101; 155; 147; 120; 137 | — |
| SECONDARY Number of Seroprotected Subjects Against Pneumococcal Serotypes |
77; 101; 155; 147; 120; 137 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes |
1.03; 1.23; 0.21; 0.3; 1.85; 1.88 | — |
| SECONDARY Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes |
21.9; 26.5; 5.1; 6.7; 109.9; 100.6 | — |
| SECONDARY Antibody Concentrations Against Protein D (Anti-PD) |
861.8; 1223.3; 349.7; 499.8; 1629.8; 2113 | — |
| SECONDARY Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Toxoids |
1.791; 3.123; 0.326; 0.725; 5.423; 8.262 | — |
| SECONDARY Antibody Concentrations Against Polyribosyl Ribitol Phosphate (Anti-PRP) |
1.179; 2.186; 0.431; 0.777; 16.943; 21.654 | — |
| SECONDARY Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) |
36.1; 33.8; 9.8; 10.2; 78.2; 65.5 | — |
| SECONDARY Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) |
293.7; 478.6; 84.3; 156.6; 1892.3; 2922.4 | — |
| SECONDARY Antibody Titers Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3) |
88.5; 99.1; 24.6; 14.4; 1006.4; 645 | — |
| SECONDARY Number of Subjects With Booster Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN Antibodies |
20; 23; 115; 114; 135; 137 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
92; 110; 14; 12; 137; 135 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
130; 130; 9; 4; 123; 124 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events |
63; 72 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events |
63; 72 | — |
| SECONDARY Number of Subjects With Serious Adverse Events |
2; 1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events |
2; 1 | — |
Summary
Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)
Eligibility Criteria
Inclusion criteria
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks.
Exclusion criteria
- Use of any investigational or non-registered 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.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after the 1 month post-dose 2 or 3 (2-4-11 or 2-3-4-11 months of age schedule) blood sampling and a minimum of 30 days before the pre-booster dose blood sampling.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae.
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00307034). 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.