Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

Pneumococcal Infections Clinical Trial

Official title:

A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427895
• Other study ID #: 6115A1-004
• Secondary ID: B1851019
• Status: Completed
• Phase: Phase 3
• Start date: February 27, 2007
• Est. completion date: August 1, 2011

Study information

• Verified date: November 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

Other known NCT identifiers

• NCT00488852
• NCT00774410

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2141
• Est. completion date: August 1, 2011
• Est. primary completion date: August 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
• Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
• Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Exclusion Criteria:

• Previous immunization with any licensed or experimental pneumococcal vaccine.
• Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which in the investigator's opinion precludes the subject from participating in the study.
• Known or suspected impairment of immunological function.

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered on day 1
• 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
0.5 mL dose administered on day 1
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered on day 1
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered on day 1
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered 3-4 years after dose 1
• 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
0.5 mL dose administered 3-4 years after dose 1
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered 3-4 years after dose 1

Locations

Country	Name	City	State
United States	Kentucky Pediatric /Adult Research	Bardstown	Kentucky
United States	Internal Medicine and Pediatrics Associates of Bristol, PC	Bristol	Tennessee
United States	PMG Research of Bristoll, LLC	Bristol	Tennessee
United States	PMG Research of Raleigh, LLC	Cary	North Carolina
United States	East Valley Family Physicians, PLC	Chandler	Arizona
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Accelovance	Huntsville	Alabama
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	University of Louisville	Louisville	Kentucky
United States	Advanced Clinical Research	Meridian	Idaho
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Clinical Research Advantage/Central Phoenix	Phoenix	Arizona
United States	Primary Physicians Research	Pittsburgh	Pennsylvania
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	University of Rochester Medical Center	Rochester	New York
United States	Radiant Research - St. Louis	Saint Louis	Missouri
United States	J. Lewis Research Inc./Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research Inc./Foothill Family Clinic South	Salt Lake City	Utah
United States	Group Health Research Institute	Seattle	Washington
United States	Accelovance	South Bend	Indiana
United States	Primary Physicians Research	Upper Saint Clair	Pennsylvania
United States	Omega Medical Research	Warwick	Rhode Island
United States	Advanced Clinical Research	West Jordan	Utah
United States	J. Lewis Research/First Med	West Jordan	Utah
United States	Heartland Research Associates LLC	Wichita	Kansas
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 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).	Within 14 days after vaccination 2
Other	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2	Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.	Within 14 days after vaccination 2
Other	Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 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 [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).	Within 14 days after vaccination 1
Other	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1	Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.	Within 14 days after vaccination 1
Primary	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1	Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	One month after vaccination 1
Primary	Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1	For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.	One month after vaccination 1
Primary	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group	Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Secondary	Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1	Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.	One month after vaccination 1
Secondary	Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2	Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.	Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
Secondary	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination	Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.	One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

External Links

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