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Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

Phase 3
Completed
Conditions
Influenza
Registration Number
NCT00521586
Lead Sponsor
Pfizer
Brief Summary

This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1116
Inclusion Criteria
  • Male or female aged 50 to 59 years
  • Determined by medical history, physical examination and clinical judgement to be eligible for the study
  • Able to complete electronic diary
  • Available for the 5 year 9 month duration of the study
Exclusion Criteria
  • Previous vaccination with any licensed or experimental pneumococcal vaccine
  • Allergic to egg proteins and chicken proteins
  • History of Guillian-Barre syndrome
  • Vaccination with TIV within 6 months before study start
  • Vaccination with diphtheria-containing vaccine within 6 months of study start
  • Serious chronic disorders including immunodeficiency or metastatic malignancy
  • Known or suspected hypersensitivity to any vaccine or vaccine component

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 11 month after Dose 1

Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose1 month after 13vPnC Dose at year 0

Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (37)

Clinical Research Advantage, Inc.

🇺🇸

Chandler, Arizona, United States

Peninsula Research Associates

🇺🇸

Rolling Hills Estates, California, United States

Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials

🇺🇸

Aurora, Colorado, United States

Tampa Bay Medical Research, Inc.

🇺🇸

Clearwater, Florida, United States

A. G. A. Clinical Trials

🇺🇸

Hialeah, Florida, United States

Advanced Clinical Research

🇺🇸

West Jordan, Utah, United States

Accelovance

🇺🇸

Peoria, Illinois, United States

Suite 100

🇺🇸

Riverdale, Maryland, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Radiant Research, Inc

🇺🇸

St. Louis, Missouri, United States

Scroll for more (27 remaining)
Clinical Research Advantage, Inc.
🇺🇸Chandler, Arizona, United States

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