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

NCT02124161 | Completed Phase 4 Results

• 1 other identifier: B1851138
• Study Type: interventional
• Target: 882
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE

Keywords

Pneumococcal polysaccharide vaccine; 13-valent pneumococcal conjugate vaccine; invasive pneumococcal disease; flu vaccine

Outcome Measures

Primary Outcomes (6)

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

  Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.

  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)

  HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.

  1 month after Vaccination 1

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

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

  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

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

  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

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

  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

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

  Within 168 to 196 days after Vaccination 2

Secondary Outcomes (5)

• Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

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

• Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1

  Immediately before Vaccination 1, 1 month after Vaccination 1

• Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2

  Immediately before Vaccination 2, 1 month after Vaccination 2

• Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers

  Immediately before Vaccination 1, 1 month after Vaccination 1

• Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1

  Immediately before Vaccination 1, 1 month after Vaccination 1

Study Arms (2)

13vPnC+SIIV/Placebo

OTHER

Biological: 13-valent pneumococcal conjugate vaccine; Biological: Seasonal Inactivated Influenza Vaccine; Other: Placebo

Placebo+SIIV/13vPnC

OTHER

Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine; Biological: 13-valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

Also known as: 13vPnC

13vPnC+SIIV/Placebo

Seasonal Inactivated Influenza Vaccine BIOLOGICAL

One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.

Also known as: SIIV

13vPnC+SIIV/Placebo

Placebo OTHER

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

13vPnC+SIIV/Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (44)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Optimal Research (Formerly Accelovance)

Huntsville, Alabama, 35802, United States

Location

Radiant Research, Inc.

Scottsdale, Arizona, 85251, United States

Location

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

Location

Kaiser Permanante South. Sacramento

Sacramento, California, 95823, United States

Location

Benchmark Research

San Francisco, California, 94108, United States

Location

Kaiser Pemanente Santa Clara

Santa Clara, California, 95051, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Optimal Research, LLC

Mishawaka, Indiana, 46545, United States

Location

Clinical Research Advantage, Inc/Ridge Family Practice

Council Bluffs, Iowa, 51503, United States

Location

Johnson County Clin-Trials, Inc.

Lenexa, Kansas, 66219, United States

Location

Benchmark Research

Metairie, Louisiana, 70002, United States

Location

Meridian Clinical Research

Bellevue, Nebraska, 68005, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, 89104, United States

Location

Clinical Research Advantage, Inc.

Las Vegas, Nevada, 89128, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28602, United States

Location

Clinical Trials of America, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Radiant Research, Inc

Columbus, Ohio, 43212, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Preferred Primary Care Physicians, Inc.

Carnegie, Pennsylvania, 15106, United States

Location

Brandywine Clinical Research

Downingtown, Pennsylvania, 19335, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

PMG Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Benchmark Research

Fort Worth, Texas, 76735, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

Murray, Utah, 84123, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research, Inc. / Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

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 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 1, 2016
• Results First Posted: July 1, 2016

Record last verified: 2016-04

Locations

US (44)