Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Vaccines
• Intervention / Treatment: Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 23-valent Pneumococcal Polysaccharide Vaccine; Biological: 23-valent Pneumococcal Polysaccharide Vaccine

• Study Type: Interventional
• Enrollment (Actual): 720
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Pfizer Investigational Site
  • Florida
    • Pembroke Pines, Florida, United States, 33024
      • Pfizer Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83704
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Pfizer Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or Female, aged 60 to 64 years.
• Healthy.

Exclusion Criteria:

• Previous vaccination with any licensed or experimental pneumococcal vaccine.
• History of severe adverse reaction associated with a vaccine.
• Immunodeficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1.1; Group 1.1 = 13vPnC then 13vPnC	Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1; Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1; Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
Experimental: Group 1.2; Group 1.2 = 13vPnC then 23vPS	Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1; Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1; Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; Biological: 23-valent Pneumococcal Polysaccharide Vaccine; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; Biological: 23-valent Pneumococcal Polysaccharide Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Experimental: Group 2; Group 2 = 23vPS then 13vPnC	Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1; Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1; Biological: 13 valent Pneumococcal Conjugate Vaccine; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; Biological: 23-valent Pneumococcal Polysaccharide Vaccine; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; Biological: 23-valent Pneumococcal Polysaccharide Vaccine; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)	Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).	14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.	14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC	Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.	14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 17, 2007

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 18, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Vaccines, Pneumococcal Conjugate Vaccine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6115A1-3010; B1851027