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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00521586
First received: August 24, 2007
Last updated: July 15, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 1116
Study Start Date: September 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521586

  Show 37 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: July 15, 2014
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 July 29, 2014