Phase 3
N=962
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01025336 ↗Enrolled (actual)
962
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548) — 54; 52; 36; 19 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood draw (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548) |
54; 52; 36; 19; 27; 18 | — |
| PRIMARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572) |
38; 22; 20; 16; 265; 172 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) |
141; 149; 70; 54; 52; 36 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) |
80; 34; 39; 22; 50; 32 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) |
52; 56; 44; 52; 50; 34 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572) |
33; 21; 38; 22; 16; 16 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) |
229; 228; 147; 54; 47; 35 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) |
92; 53; 39; 22; 52; 51 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) |
7; 6; 7; 54; 52; 36 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) |
10; 10; 38; 22; 9; 10 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548) |
52; 36; 27; 18; 355; 183 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548) |
54; 36; 19; 18; 328; 183 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548) |
54; 52; 19; 27; 328; 355 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572) |
38; 22; 20; 16; 265; 172 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) |
52; 45; 27; 26; 355; 332 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) |
36; 54; 18; 21; 183; 622 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548) |
52; 52; 19; 18; 710; 376 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) |
22; 33; 16; 16; 172; 123 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) |
33; 38; 16; 19; 129; 267 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548) |
54; 45; 21; 26; 622; 332 | — |
| SECONDARY Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572) |
33; 21; 16; 16; 123; 68 | — |
Summary
The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the second vaccine dose in two groups of adults over the age of 60: (1) those who have previously received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and 23vPS, administered in different sequential order results in different prolonged antibody levels. This study is limited to individuals who participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572).
Eligibility Criteria
Inclusion Criteria
- Only study volunteers who received both assigned vaccinations at visit 1 and visit 4 when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572)
Exclusion Criteria
- Vaccination with any licensed or experimental pneumococcal vaccine since being enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other than study vaccines permitted in 6115A1-3010 or 6115A1-3005)
Data sourced from ClinicalTrials.gov (NCT01025336). 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.