Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500

This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Amanzimtoti, South Africa, 4126
  • Bishop Lavis, South Africa, 7490
  • Bloemfontein, South Africa, 9317
  • Brits, South Africa, 0250
  • Cape Town, South Africa, 7941
  • Cape Town, South Africa, 7945
  • Lenasia, South Africa, 1827
  • Paarl, South Africa, 7646
  • Parow, South Africa, 7500
  • Parys, South Africa, 9585
  • Pretoria, South Africa, 0002
  • Pretoria, South Africa, 0083
  • Pretoria, South Africa, 0082
  • Pretoria, South Africa, 0183
  • Scottburgh South, South Africa, 4180
  • Vanderbijlpark, South Africa, 1911

Participation Criteria

Eligibility Criteria

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

Description

• Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
• Generally healthy male or female adults 65 years of age or older
• Available for the duration of the trial - approximately 1 month

• No history of severe adverse reaction associated with a vaccine

  • MMSE score less than or equal to 21 was an exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)	Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 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.	Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)	Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 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.	Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)	Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.	Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)	Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.	Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)	Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).	Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.	Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimate): July 12, 2007

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 15, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6115A1-3009