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

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

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).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 13vPnC + TIV

• Study Type: Interventional
• Enrollment (Actual): 1185
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)	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.	Baseline and 1 month after TIV vaccination
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)	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.	1 month after 13vPnC vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pre-specified Local Reactions	Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).	Days 1 through 14 after 13vPnC vaccination
Percentage of Participants With Pre-specified Systemic Events	Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.	Days 1 through 14 after 13vPnC vaccination

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 26, 2007
• First Submitted That Met QC Criteria: June 26, 2007
• First Posted (Estimate): June 27, 2007

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: January 17, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Pneumococcal Conjugate Vaccine; Pneumococcal Disease
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6115A1-3008