Phase 2
Completed N=338
A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT02531373 ↗
Enrolled (actual)
338
Serious AEs
5.1%
Results posted
Apr 2018
Primary outcomePrimary: Adults: Percentage of Participants With an Adverse Event — 90.0; 95.0; 95.0; 95.0 Percentage of participants
Summary
This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adults: Percentage of Participants With an Adverse Event |
90.0; 95.0; 95.0; 95.0 | — |
| PRIMARY Infants: Percentage of Participants With an Adverse Event |
96.0; 94.0; 96.1; 98.1; 100.0 | — |
| PRIMARY Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Infants: Percentage of Participants With a Solicited Injection-site Adverse Event |
78.0; 80.0; 58.8; 80.8; 57.7 | 0.029 sig |
| PRIMARY Infants: Percentage of Participants With a Solicited Systemic Adverse Event |
88.0; 86.0; 92.2; 94.2; 88.5 | 0.943 |
| PRIMARY Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies |
1.33; 1.49; 1.63; 0.94; 1.12; 0.53 | — |
| SECONDARY Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies |
3.47; 4.99; 0.50; 0.71; 0.96; 1.47 | — |
| SECONDARY Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies |
14.94; 14.41; 3.12; 4.73; 7.24; 12.66 | — |
| SECONDARY Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 |
97.3; 100.0; 100.0; 94.6; 97.4; 70.0 | — |
| SECONDARY Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 |
30.8; 43.6; 57.5; 10.3; 15.4; 7.5 | — |
| SECONDARY Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 |
100.0; 100.0; 100.0; 96.9; 97.1; 83.3 | — |
| SECONDARY Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies |
1.74; 2.32; 2.05; 1.02; 1.26; 0.87 | — |
| SECONDARY Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies |
1.74; 2.32; 2.05; 1.02; 1.26; 0.87 | — |
Eligibility Criteria
Inclusion Criteria
Adult Cohort: 18 to 49 years and in good health
- Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
Infant Cohort: approximately 2 months (42 to 90 days) and in good health.
Exclusion Criteria
Adult cohort: Prior administration of any pneumococcal vaccine
- History of invasive pneumococcal disease
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- Coagulation disorder contraindicating intramuscular vaccination
- Received a blood transfusion or blood products within 6 months
- Participated in another clinical study of an investigational product within 2 months
- Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- History of congenital or acquired immunodeficiency
- Has or mother has documented Human Immunodeficiency virus (HIV) infection
- Has or mother has documented hepatitis B surface antigen positive result
- Functional or anatomic asplenia
- History of failure to thrive
- Coagulation disorder contraindicating intramuscular vaccination
- History of autoimmune disease or autoimmune disorder
- Known neurologic or cognitive behavioral disorder
- Received systemic corticosteroids within 14 days
- Received other licensed non-live vaccine within 14 days
- Received other licensed live virus vaccine within 30 days
- Received a blood transfusion or blood products
- Participated in another clinical study of an investigational product
- History of invasive pneumococcal disease
Data sourced from ClinicalTrials.gov (NCT02531373). 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. Informational only — not medical advice.