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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492557
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : February 17, 2012
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumococcal Infections Biological: 13-valent pneumococcal conjugate vaccine Biological: 13vPnC + TIV Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]
    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.

  2. 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 1 month after 13vPnC vaccination ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00492557

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

Responsible Party: Pfizer Identifier: NCT00492557     History of Changes
Other Study ID Numbers: 6115A1-3008
First Posted: June 27, 2007    Key Record Dates
Results First Posted: February 17, 2012
Last Update Posted: February 17, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
Pneumococcal Disease
Pneumococcal Conjugate Vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs