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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

13 valent pneumococcal conjugate vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Pneumococcal Conjugate Vaccine

Eligibility Criteria

50 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Research Advantage, Inc.
Peninsula Research Associates
Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
Tampa Bay Medical Research, Inc.
A. G. A. Clinical Trials
Advanced Clinical Research
Accelovance
Suite 100
Mayo Clinic
Radiant Research, Inc
Big Sky Clinical Research
FFM Clinical Research
Rochester Clinical Research
University of Rochester Medical Center
PMG Research of Raleigh, LLC
Hickory Family Practice Associates
PMG Research of Hickory, LLC
Unifour Medical Research Associates, LLC
Unifour Medical Research Associates
Fairbrook Medical Clinic
PMG Research of Hickory, LLC
Unifour Medical Research Associates, LLC
PMG Research of Raleigh, LLC
PMG Research of Salisbury
PMG Research of Winston-Salem
Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
Rapid Medical Research, Inc.
Prestige Clinical Research
Preferred Primary Care Physicians, Inc
Family Healthcare Partners
Family Practice Medical Associates South, Jefferson Office
Kid's Plus Pediatrics
Primary Physicians Research Inc.
Family Practice Medical Associates South
The Washington Hospital Family Medicine
Internal Medicine & Pediatric Associates of Bristol, PC
PMG Research of Bristol, LLC
Volunteer Research Group
Clark D. McKeever, M.D. Research for Health
Diagnostics Research Group
Advanced Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00521586

First Posted

August 24, 2007

Last Updated

April 7, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00521586

Brief Title

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

Official Title

A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Pneumococcal Conjugate Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

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

Arm Title

Arm Type

Other

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

13 valent pneumococcal conjugate vaccine

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

13 valent pneumococcal conjugate vaccine

Other Intervention Name(s)

0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 month after Dose 1

Title

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

Description

Time Frame

1 month after 13vPnC Dose at year 0

Other Pre-specified Outcome Measures:

Title

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

Description

Time Frame

1 month after 13vPnC (Year 5)

Title

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

Description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.

Time Frame

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

Title

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)

Description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.

Time Frame

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

Title

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)

Description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.

Time Frame

1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)

Description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.

Time Frame

1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)

Description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.

Time Frame

before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)

Title

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 0)

Description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.

Time Frame

before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)

Description

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.

Time Frame

Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)

Title

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)

Description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.

Time Frame

Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)

Title

Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)

Description

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 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Time Frame

1 month after 13vPnC (Year 5)

Title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)

Description

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% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.

Time Frame

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

Title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)

Description

Time Frame

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

Title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)

Description

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% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points

Time Frame

1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)

Description

Time Frame

1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)

Description

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% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.

Time Frame

before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)

Description

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.

Time Frame

Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)

Title

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)

Description

Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.

Time Frame

Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)

Title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)

Description

Time Frame

Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)

Title

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)

Description

Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.

Time Frame

Within 14 days after Dose 1 (Year 0)

Title

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)

Description

Time Frame

Within 14 days after Dose 2 (Year 0)

Title

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)

Description

Time Frame

Within 14 days after 13vPnC (Year 5)

Title

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)

Description

Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.

Time Frame

Within 14 days after Dose 1 (Year 0)

Title

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)

Description

Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.

Time Frame

Within 14 days after Dose 2 (Year 0)

Title

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)

Description

Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.

Time Frame

Within 14 days after 13vPnC (Year 5)

Title

Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)

Description

Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.

Time Frame

Within 30 Minutes After Dose 1 (Year 0)

Title

Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)

Description

Time Frame

Within 30 Minutes After Dose 2 (Year 0)

Title

Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)

Description

Time Frame

Within 30 Minutes After 13vPnC (Year 5)

Title

Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)

Description

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.

Time Frame

Signing of informed consent up to 194 days after re-vaccination at Year 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Advantage, Inc.

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Peninsula Research Associates

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045-7144

Country

United States

Facility Name

Tampa Bay Medical Research, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

A. G. A. Clinical Trials

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Advanced Clinical Research

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Accelovance

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Suite 100

City

Riverdale

State/Province

Maryland

ZIP/Postal Code

20737

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Radiant Research, Inc

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Big Sky Clinical Research

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

FFM Clinical Research

City

Camillus

State/Province

New York

ZIP/Postal Code

13031

Country

United States

Facility Name

Rochester Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

PMG Research of Raleigh, LLC

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Hickory Family Practice Associates

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

PMG Research of Hickory, LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Unifour Medical Research Associates, LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Unifour Medical Research Associates

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Fairbrook Medical Clinic

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

PMG Research of Hickory, LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Unifour Medical Research Associates, LLC

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

PMG Research of Raleigh, LLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

PMG Research of Salisbury

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

PMG Research of Winston-Salem

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

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

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

Facility Name

Rapid Medical Research, Inc.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Prestige Clinical Research

City

Franklin

State/Province

Ohio

ZIP/Postal Code

45005

Country

United States

Facility Name

Preferred Primary Care Physicians, Inc

City

Carnegie

State/Province

Pennsylvania

ZIP/Postal Code

15106

Country

United States

Facility Name

Family Healthcare Partners

City

Grove City

State/Province

Pennsylvania

ZIP/Postal Code

16127

Country

United States

Facility Name

Family Practice Medical Associates South, Jefferson Office

City

Jefferson Hills

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

Facility Name

Kid's Plus Pediatrics

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15217

Country

United States

Facility Name

Primary Physicians Research Inc.

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Family Practice Medical Associates South

City

Upper St. Clair

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

The Washington Hospital Family Medicine

City

Washington

State/Province

Pennsylvania

ZIP/Postal Code

15301

Country

United States

Facility Name

Internal Medicine & Pediatric Associates of Bristol, PC

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

PMG Research of Bristol, LLC

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Volunteer Research Group

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

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

City

Houston

State/Province

Texas

ZIP/Postal Code

77055-6040

Country

United States

Facility Name

Diagnostics Research Group

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Advanced Clinical Research

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27155493

Citation

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.

Results Reference

derived

PubMed Identifier

22739693

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6115A1-3001&StudyName=Study%20Evaluating%20%2013%20Valent%20Pneumococcal%20Conjugate%20Vaccine%20with%20Trivalent%20Inactivated%20Influenza%20Vaccine

Description

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Learn more about this trial

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

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