CompletedPhase 4

Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

United States882 participantsStarted 2014-09

Plain-language summary

The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
✓. Male or female adults 50 years of age or older.
✓. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
✓. Negative urine pregnancy test for all female subjects who are of child bearing potential.

Exclusion criteria

✕. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
✕. History of severe adverse reactions associated with any vaccine or vaccine-related component.
✕. Allergic to egg proteins (egg or egg products) and chicken proteins.
✕. History of Guillain-Barré syndrome.
✕. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
✕. Documented S pneumoniae infection within the past 5 years before investigational product administration.

What they're measuring

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes

Timeframe: 1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC

Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)

Timeframe: 1 month after Vaccination 1

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1

Timeframe: Within 28 to 42 days after Vaccination 1

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2

Timeframe: Within 28 to 42 days after Vaccination 2

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination

Timeframe: Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up

Timeframe: Within 168 to 196 days after Vaccination 2

Trial details

NCT IDNCT02124161

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

Results submitted2016-05-23

View on ClinicalTrials.gov More PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE trials