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

NCT00521586 | Completed Phase 3 Results

• 2 other identifiers: 6115A1-3001B1851020
• Study Type: interventional
• Target: 1,116
• Locations: 1 country
• Sites: 41

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.

Conditions

Influenza

Keywords

Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 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.

  1 month after Dose 1

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose

  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.

  1 month after 13vPnC Dose at year 0

Other Outcomes (28)

• Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)

  1 month after 13vPnC (Year 5)

• Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)

  before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)

• Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)

  before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)

Study Arms (2)

1

OTHER

arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5

Biological: 13 valent pneumococcal conjugate vaccine

2

OTHER

arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5

Biological: 13 valent pneumococcal conjugate vaccine

Interventions

13 valent pneumococcal conjugate vaccine BIOLOGICAL

TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5

Also known as: 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle

1

Eligibility Criteria

• Age: 50 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (41)

Clinical Research Advantage, Inc.

Chandler, Arizona, 85224, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials

Aurora, Colorado, 80045-7144, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

A. G. A. Clinical Trials

Hialeah, Florida, 33012, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

Accelovance

Peoria, Illinois, 61602, United States

Location

Suite 100

Riverdale, Maryland, 20737, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Radiant Research, Inc

St Louis, Missouri, 63141, United States

Location

Big Sky Clinical Research

Butte, Montana, 59701, United States

Location

FFM Clinical Research

Camillus, New York, 13031, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

PMG Research of Raleigh, LLC

Cary, North Carolina, 27518, United States

Location

Hickory Family Practice Associates

Hickory, North Carolina, 28601, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28601, United States

Location

Unifour Medical Research Associates, LLC

Hickory, North Carolina, 28601, United States

Location

Unifour Medical Research Associates

Hickory, North Carolina, 28601, United States

Location

Fairbrook Medical Clinic

Hickory, North Carolina, 28602, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28602, United States

Location

Unifour Medical Research Associates, LLC

Hickory, North Carolina, 28602, United States

Location

PMG Research of Raleigh, LLC

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies

Cincinnati, Ohio, 45206, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Preferred Primary Care Physicians, Inc

Carnegie, Pennsylvania, 15106, United States

Location

Family Healthcare Partners

Grove City, Pennsylvania, 16127, United States

Location

Family Practice Medical Associates South, Jefferson Office

Jefferson Hills, Pennsylvania, 15025, United States

Location

Kid's Plus Pediatrics

Pittsburgh, Pennsylvania, 15217, United States

Location

Primary Physicians Research Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Family Practice Medical Associates South

Upper Saint Clair, Pennsylvania, 15241, United States

Location

The Washington Hospital Family Medicine

Washington, Pennsylvania, 15301, United States

Location

Internal Medicine & Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

PMG Research of Bristol, LLC

Bristol, Tennessee, 37620, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Clark D. McKeever, M.D. Research for Health

Houston, Texas, 77055-6040, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (2)

• Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.

  PMID: 27155493 DERIVED

• Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.

  PMID: 22739693 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 28, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 9, 2015
• Results First Posted: April 9, 2015

Record last verified: 2015-04

Locations

US (41)