Phase 3
N=524
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
Infections, Streptococcal · Streptococcus Pneumoniae Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00624819 ↗Enrolled (actual)
524
Serious AEs
0.2%
Results posted
Mar 2020
Primary outcome: Primary: Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] — 372; 7; 99; 384 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK1024805A (Biological); Prevenar (Biological); Infanrix hexa (Biological); Havrix (Biological); Varilrix (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
372; 7; 99; 384; 31; 102 | — |
| PRIMARY Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
354; 18; 90; 356; 30; 96 | — |
| PRIMARY Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
238; 14; 71; 238; 18; 72 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
0.29; 0.04; 0.26; 0.5; 0.59; 1.01 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
0.19; 0.07; 0.17; 0.27; 0.3; 0.52 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
0.2; 0.17; 0.23; 0.19; 0.23; 0.31 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
0.1; 5.36; 3.04; 5; 1.35; 2.39 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
16.2; 4.8; 7.3; 59.8; 192.9; 88.9 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
8.4; 4; 6.3; 29; 33.5; 39.3 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
8.8; 4.6; 8.9; 37.9; 62.2; 50.7 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
5; 2920.8; 1331; 1816.1; 605; 128.3 | — |
| SECONDARY Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
0.28; 0.44; 0.27; 0.28; 0.21; 0.23 | — |
| SECONDARY Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) - Follow-Up Period: Persistence Analysis in Year 2 (111346 Sub-study) |
0.33; 0.57; 0.4; 0.37; 0.25; 0.35 | — |
| SECONDARY Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and - 19A) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
0.92; 0.69; 0.75; 1.3; 1.08; 1.14 | — |
| SECONDARY Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
0.2; 2.2; 1.67; 1.33; 0.44; 0.92 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
59; 610.2; 46.6; 6; 5.9; 5.5 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
121.8; 356.5; 133.7; 12.8; 10.9; 11.1 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Crossreactive Pneumococcal Serotypes 6A and 19 A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
213.5; 227.8; 153.5; 31.2; 14.3; 21.8 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
102.6; 1217.7; 1490.2; 467.7; 826.5; 943.4 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study) |
822.1; 93.9; 193.6 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) - Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study) |
573.2; 116.7; 157.5 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
372.4; 144.9; 161.4 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
106; 2106; 718.2; 680.7; 382.9; 708.6 | — |
| SECONDARY Number of Subjects Reported With Solicited Local Symptoms |
157; 9; 34; 54; 90; 5 | — |
| SECONDARY Number of Subjects Reported With Solicited General Symptoms |
49; 2; 12; 12; 1; 0 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
25; 0; 3; 6 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [Follow-up Period: Year 1 (111345 Sub-study)] |
1; 0; 0 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedures [(Follow-up Period: Year 2 (111346 Sub-study) Until Year 4 (111347 Sub-study)] |
0; 0; 0 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) [Follow-up Period: Vaccination Period in Year 4 (111347 Sub-study)] |
0; 0; 0; 0 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
188; 2; 26; 201; 21; 65 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
92; 0; 15; 146; 12; 48 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
55; 1; 17; 107; 8; 33 | — |
| SECONDARY Number of Seropositive Subjects for Opsophagocytic Activity Against Pneumococcal Serotypes [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
8; 193; 13; 48; 90; 87 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
376; 31; 97; 366; 29; 93 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
330; 30; 86; 319; 25; 83 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
256; 18; 72; 260; 18; 74 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
76; 208; 14; 54; 92; 97 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
196; 24; 45; 45; 3; 10 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)] |
235; 21; 62; 115; 8; 29 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
194; 12; 51; 135; 7; 34 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
57; 185; 12; 46; 88; 87 | — |
| SECONDARY Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)] |
373; 11; 71 | — |
| SECONDARY Number of Seropositive Subjects for Anti Protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 2 (111345 Sub-study)] |
340; 15; 65 | — |
| SECONDARY Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)] |
241; 12; 54 | — |
| SECONDARY Number of Seropositive Subjects for Anti-protein D (Anti-PD) [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
54; 207; 14; 54; 92; 98 | — |
| SECONDARY Number of Seropositive Subjects for Anti-vaccine Pneumococcal Serotypes Antibodies [Follow-up Period: Immunogenicity Analysis in Year 4 (111347 Sub-study)] |
69; 207; 14; 54; 97; 98 | — |
Summary
This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).
Eligibility Criteria
Inclusion Criteria
- Male or female between, and including, 28-30 months of age at the time of first blood sampling.
- Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Written informed consent, covering visits 1, 2 and 3, 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
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
- Administration of any additional pneumococcal vaccine since end of 107046 study.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
- Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
- Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.
Data sourced from ClinicalTrials.gov (NCT00624819). 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.