Phase 3
N=443
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00950833 ↗Enrolled (actual)
443
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Antibody Concentrations Against Vaccine Pneumococcal Serotypes — 1.24; 7.63; 4.52; 12.95 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pneumococcal vaccine GSK1024850A (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Concentrations Against Vaccine Pneumococcal Serotypes |
2.33; 6.26; 2.69; 0.84; 3.63; 1.73 | — |
| SECONDARY Antibody Concentrations Against Vaccine Pneumococcal Serotypes |
2.33; 6.26; 2.69; 0.84; 3.63; 1.73 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes |
125.6; 2451.2; 57.2; 1345; 6527.2; 6091.6 | — |
| SECONDARY Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A |
0.51; 1.99 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
918.6; 597.6 | — |
| SECONDARY Antibody Concentrations Against Protein D (Anti-PD) |
785.9 | — |
| SECONDARY Memory B-cell Detection for Vaccine Polysaccharides (PS) |
288.6; 269.5; 254.8; 1488.8; 1017.4; 755.9 | — |
| SECONDARY Antibody Concentrations Against Vaccine Pneumococcal Serotypes |
2.33; 6.26; 2.69; 0.84; 3.63; 1.73 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes |
125.6; 2451.2; 57.2; 1345; 6527.2; 6091.6 | — |
| SECONDARY Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A |
0.51; 1.99 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
918.6; 597.6 | — |
| SECONDARY Antibody Concentrations Against Protein D (Anti-PD) |
785.9 | — |
| SECONDARY Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men) |
325.5; 63.6; 372.2; 247.6 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
150; 13; 102; 23; 78; 14 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
150; 13; 102; 23; 78; 14 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
79; 1; 56; 69; 2; 49 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
79; 1; 56; 69; 2; 49 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
24; 29; 73 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0; 0 | — |
| SECONDARY Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes) |
40; 21; 46; 20 | — |
| SECONDARY Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes) |
9; 13; 19; 18 | — |
| SECONDARY Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) |
25; 34; 27; 35 | — |
| SECONDARY Number of Nasopharyngeal Swabs With Haemophilus Influenzae |
43; 54; 89; 74 | — |
| SECONDARY Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs |
39; 20; 41; 18 | — |
| SECONDARY Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs |
9; 13; 18; 18 | — |
| SECONDARY Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs |
24; 32; 25; 33 | — |
| SECONDARY Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs |
35; 49; 70; 50 | — |
Summary
The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
This protocol posting deals with objectives & outcome measures of the extension phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 31 and 34 months of age at the time of the enrolment.
- Subjects who previously participated in study NCT00496015
- For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
- For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
- 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.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
- 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).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of seizures or progressive neurological disease.
- Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
- Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
- Administration of any pneumococcal vaccine since the end of study NCT00496015.
Data sourced from ClinicalTrials.gov (NCT00950833). 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.