Phase 2
N=257
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00985751 ↗Enrolled (actual)
257
Serious AEs
6.6%
Results posted
Oct 2017
Primary outcome: Primary: Number of Subjects With Fever > 40.0°C (Rectal Temperature) — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pneumococcal vaccine GSK2189242A (formulation 1) (Biological); Pneumococcal vaccine GSK2189242A (formulation 2) (Biological); Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) (Biological); Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4) (Biological); Pneumococcal vaccine GSK1024850A (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Fever > 40.0°C (Rectal Temperature) |
0; 1 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
18; 15; 31; 23; 26; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms |
16; 13; 24; 20; 26; 0 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
14; 12; 13; 4; 9 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
14; 12; 13; 4; 9 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
5; 3; 5; 0; 4 | — |
| SECONDARY Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations |
135703.5; 148447.5; 32436.07; 57149.83; 3759.82; 100811.4 | — |
| SECONDARY Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations |
0.04; 0.05; 2.5; 2.08; 2.13; 0.05 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes |
4; 5.4; 71.8; 48.2; 90; 4 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) |
90.9; 100.4; 1105.4; 600.2; 860; 89.1 | — |
| SECONDARY Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity |
3080; 2988.7; 1278.9; 1814; 913.2; 2441.1 | — |
Summary
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).
Eligibility Criteria
Inclusion Criteria
- 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, 12 and 23 months of age at the time of the first vaccination.
- Written 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.
Exclusion Criteria
- 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).
- Previous vaccination against S. pneumoniae since birth.
- History of any hypersensitivity reaction following any previous vaccination.
- Eczema and any history of allergy
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or any chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
- Child in care.
Data sourced from ClinicalTrials.gov (NCT00985751). 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.