Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00521586
First received: August 24, 2007
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Biological: 13 valent pneumococcal conjugate vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 (TIV) 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To compare the immune response to TIV administered with 13vPnC to the immune response to TIV alone as measured by hemagglutination inhibition assay (HAI). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • To compare the immune response to 13vPnC as given above measured by serotype specific IgG. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Safety of 13vPnC measured by local reactions. [ Time Frame: 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Safety of 13vPnC measured by systemic events. [ Time Frame: 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Safety of 13vPnC measured by adverse events. [ Time Frame: Ongoing through study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: September 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
 Biological: 13 valent pneumococcal conjugate vaccine
TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
Other Name: 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
2
arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5
 Biological: 13 valent pneumococcal conjugate vaccine
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5
Other Name: 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

  Eligibility

Ages Eligible for Study:   50 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521586

  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00521586     History of Changes
Other Study ID Numbers: 6115A1-3001, B1851020
Study First Received: August 24, 2007
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pneumococcal Conjugate Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013