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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00427895
First received: January 25, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Pneumococcal Infections
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 to 59 Years Old Who Are Naïve to 23vPS

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1 [ Time Frame: One month after vaccination 1 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1 [ Time Frame: One month after vaccination 1 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1 [ Time Frame: One month after vaccination 1 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 [ Time Frame: Within 14 days after vaccination 1 ] [ Designated as safety issue: Yes ]
    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).

  • Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2 [ Time Frame: Within 14 days after vaccination 2 ] [ Designated as safety issue: Yes ]
    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).

  • Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 [ Time Frame: Within 14 days after vaccination 1 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2 [ Time Frame: Within 14 days after vaccination 2 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2141
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 13vPnC Cohort 1, Vaccination 1
Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered on day 1
Active Comparator: 23vPS Cohort 1, Vaccination 1
Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
0.5 mL dose administered on day 1
Experimental: 13vPnC Cohort 2, Vaccination 1
Participants aged 50-59 years given a 0.5 mL dose administered on day 1.
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered on day 1
Experimental: 13vPnC Cohort 3, Vaccination 1
Participants aged 18-49 years given a 0.5 mL dose administered on day 1.
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered on day 1
Experimental: 13vPnC Cohort 1, Vaccination 2
Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered 3-4 years after dose 1
Active Comparator: 23vPS Cohort 1, Vaccination 2
Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1.
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
0.5 mL dose administered 3-4 years after dose 1
Experimental: 13vPnC Cohort 2, Vaccination 2
Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL dose administered 3-4 years after dose 1

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427895

  Show 25 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00427895     History of Changes
Obsolete Identifiers: NCT00488852, NCT00774410
Other Study ID Numbers: 6115A1-004, B1851019
Study First Received: January 25, 2007
Results First Received: August 1, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Vaccine
Pneumococcal Infections Prevention and Control

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014