Phase 4
N=200
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
13-valent Pneumococcal Vaccine · Premature Birth · Immunization · Safety
Bottom Line
View on ClinicalTrials.gov: NCT01193335 ↗Enrolled (actual)
200
Serious AEs
7.6%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series — 96.97; 98.97; 72.73; 87.63 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series |
96.97; 98.97; 72.73; 87.63; 96.97; 96.91 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series |
1.96; 2.46; 0.73; 1.30; 1.26; 1.70 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series |
48.9; 42.0; 46.2; 31.8; 17.8; 16.5 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series |
48.2; 38.6; 43.5; 31.0; 14.3; 15.7 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series |
39.0; 28.6; 35.8; 26.2; 9.3; 5.1 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose |
69.8; 55.3; 66.3; 51.8; 20.8; 11.4 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series |
11.6; 13.6; 10.5; 13.6; 1.2; 0.0 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series |
27.8; 31.6; 27.8; 30.4; 0.0; 1.3 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series |
27.8; 30.9; 26.9; 30.9; 1.3; 2.6 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose |
28.8; 43.6; 27.5; 42.9; 1.4; 4.2 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series |
59.0; 55.0; 14.0; 5.0 | 0.668 |
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series |
18.0; 15.0; 8.0; 9.0 | 0.704 |
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose |
31.3; 26.8; 2.0; 1.0 | 0.531 |
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose |
15.2; 8.2; 13.1; 8.2 | 0.183 |
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose |
8.0; 10.2; 6.8; 9.1 | 0.794 |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose |
8.14; 9.61; 9.46; 7.61; 5.85; 4.92 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C |
100.00; 96.00; 96.00; 79.17; 72.00; 68.00 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose |
100.00; 100.00; 97.67; 100.00; 100.00; 100.00 | — |
| SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C |
100.00; 100.00; 100.00; 100.00; 95.56; 100.00 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose |
0.31; 0.41; 0.48; 0.94; 0.39; 0.62 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose |
2.57; 3.97; 4.42; 7.27; 2.30; 3.06 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose |
0.30; 0.37; 1.26; 2.01; 0.61; 0.98 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose |
0.19; 0.24; 1.44; 2.70; 0.74; 0.99 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C |
2.50; 1.86; 1.73; 1.23; 0.61; 0.62 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C |
0.37; 0.28; 0.32; 0.59; 0.42; 0.49 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C |
3.58; 2.87; 1.41; 6.28; 4.28; 3.29 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C |
0.30; 0.29; 0.32; 1.49; 1.28; 1.06 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C |
0.17; 0.19; 0.21; 1.39; 1.81; 0.96 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series |
1231; 923; 835; 732; 151; 211 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose |
10; 13; 12; 15; 11; 7 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose |
1154; 1757; 1229; 1406; 1871; 2542 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose |
24; 29; 38; 36; 141; 244 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose |
15; 17; 29; 27; 132; 75 | — |
| SECONDARY Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series |
100.00; 100.00; 90.20; 95.08; 64.81; 71.67 | — |
| SECONDARY Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose |
21.43; 30.51; 22.03; 27.42; 19.23; 12.70 | — |
| SECONDARY Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose |
100.00; 100.00; 98.44; 98.36; 95.00; 96.55 | — |
| SECONDARY Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose |
34.8; 42.4; 41.5; 47.5; 62.3; 73.0 | — |
| SECONDARY Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose |
21.7; 29.6; 35.7; 35.4; 60.0; 52.7 | — |
Summary
The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.
Eligibility Criteria
Inclusion Criteria
- Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
Exclusion Criteria
- Previous vaccination with pneumococcal vaccine, Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
- Previous anaphylactic reaction or allergy to any vaccine
- Contraindication to vaccination
- Known or suspected immune deficiency or immune suppression
- Major known congenital malformation or serious chronic disorder
- Significant neurological disorder
- Participation to another study
Data sourced from ClinicalTrials.gov (NCT01193335). 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.