Influenza Vaccine and Pneumococcal Vaccine

Influenza, Human Clinical Trial

Official title:

Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582047
• Other study ID #: INFLUENZAPNEUMO
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: October 19, 2015
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2015
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.

Description:

During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adults aged =65 years who signed the informed consent

Exclusion Criteria:

• Previous pneumococcal vaccine recipients

• Egg allergy

• History of serious adverse event after vaccination

• Any acute disease or infection

• History of neurological symptoms or signs

• Impairment of immune function or immunosuppressant use

• Bleeding diathesis

• Fever (defined as axillary temperature ³38.0°C) within 3 days

• History of Streptococcal pneumoniae infection within the previous 5 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Pneumococcal Infections

Intervention

Biological:
• Influenza vaccination with PPV23
GCflu and Pneumovax-23
• Influenza vaccination with PCV13
GCflu and Prevenar-13

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Kyoungido
Korea, Republic of	Hallym University Gangnam Sacred Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency and duration of local and systemic adverse events	the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials	Monitor using a clinical diary for seven days after vaccination	Yes
Primary	Seroconversion rates (A/H1N1, A/H3N2, and B)	Seroconversion: a post-vaccination titer =1:40 in subjects with a pre-vaccination titer of <1:10 or a =4-fold titer increase in subjects with a pre-vaccination titer of =1:10	Change from baseline titer at 4 weeks	No
Secondary	Seroprotection rates (A/H1N1, A/H3N2, and B)	Seroprotection rate: percentage of subjects with a post-vaccination titer =1:40	Change from baseline titer at 4 weeks	No
Secondary	GMT folds (A/H1N1, A/H3N2, and B)	GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer	Change from baseline titer at 4 weeks	No