Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00492557
First received: June 26, 2007
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).


Condition Intervention Phase
Pneumococcal Infections
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 13vPnC + TIV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older, Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) [ Time Frame: Baseline and 1 month after TIV vaccination ] [ Designated as safety issue: No ]
    Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.

  • 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 1 month after 13vPnC vaccination ] [ Designated as safety issue: No ]
    IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.


Enrollment: 1185
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 13vPnC+TIV Followed by Placebo 1 month later Biological: 13-valent pneumococcal conjugate vaccine
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.
Active Comparator: Placebo+TIV Followed by 13vPnC 1 month later Biological: 13vPnC + TIV
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy male or female adults 65 years of age or older.
  • Available for the duration of the trial - approximately 2 months.
  • No previous vaccination with any pneumococcal vaccine.
  • No history of severe adverse reaction associated with a vaccine.
  • No allergy to egg proteins (eggs or egg products) and chicken proteins.
  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: NCT00492557

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00492557     History of Changes
Other Study ID Numbers: 6115A1-3008
Study First Received: June 26, 2007
Results First Received: January 17, 2012
Last Updated: January 17, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Pfizer:
Pneumococcal Disease
Pneumococcal Conjugate Vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 16, 2014