Phase 4
N=162
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Pneumococcal Pneumonia · Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02592486 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. — 63; 59 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Simultaneous administration of Pneumovax NP® and Fluvic HA syringe® (Biological); Sequential administration of Pneumovax NP® and Fluvic HA syringe® (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Kameda Medical Center
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. |
63; 59 | — |
| SECONDARY The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody. |
56; 52; 54; 66; 59; 63 | — |
| SECONDARY The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A) |
0.40; 0.20; 0.07; 0.07; 0.08; 0.05 | — |
| SECONDARY The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine. |
68; 60; 66; 68; 33; 45 | — |
Summary
The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.
Eligibility Criteria
Inclusion Criteria
- adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season
Exclusion Criteria
- a sensitivity to pneumococcal and influenza vaccine
- received other inactivated vaccine within 14 days
- received other live vaccine within 28 days
- the presence of conditions known to impair pneumococcal vaccine response
- having malignant disease
- taking oral corticosteroids or immunosuppressive agent
- history of splenectomy
- history of an acute febrile illness or signs of severe acute illness at the time of vaccination
- other inappropriate condition to receive vaccination
- suffering an acute illness requiring antibiotics or steroids within the past month
- not expected to survive 12 months were also excluded
Data sourced from ClinicalTrials.gov (NCT02592486). 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.