Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00743652
First received: August 27, 2008
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.


Condition Intervention Phase
Pneumococcal Disease
13-valent Pneumococcal Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.

  • Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) [ Time Frame: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ] [ Designated as safety issue: No ]
    Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 [ Time Frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. ] [ Designated as safety issue: Yes ]
    Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 [ Time Frame: Day 1 through Day 7 after vaccination 2 for Group 4 ] [ Designated as safety issue: Yes ]
    Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 [ Time Frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. ] [ Designated as safety issue: Yes ]
    Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 [ Time Frame: Day 1 through Day 7 after vaccination 2 for Group 4 ] [ Designated as safety issue: Yes ]
    Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.


Enrollment: 373
Study Start Date: January 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group1
Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
Biological: 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
Experimental: Group 2
Subjects <12 months of age with 1 prior dose of Prevnar.
Biological: 13-valent Pneumococcal Conjugate Vaccine
3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
Experimental: Group 3
Subjects <12 months of age with 2 prior doses of Prevnar.
Biological: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
Experimental: Group 4
Subjects ≥12 months to <2 years of age.
Biological: 13-valent Pneumococcal Conjugate Vaccine
2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
Experimental: Group 5
Subjects ≥2 years to <5 years of age
Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)

  Eligibility

Ages Eligible for Study:   42 Days to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
  • Infants who have received Prevnar are eligible to participate, but this is not required.
  • Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria:

  • Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743652

Locations
United States, Alaska
Pfizer Investigational Site
Akiak, Alaska, United States, 99552
Pfizer Investigational Site
Bethel, Alaska, United States, 99559
Pfizer Investigational Site
Chefornak, Alaska, United States, 99561
Pfizer Investigational Site
Chevak, Alaska, United States, 99563
Pfizer Investigational Site
Eek, Alaska, United States, 99578
Pfizer Investigational Site
Emmonak, Alaska, United States, 99581
Pfizer Investigational Site
Hooper Bay, Alaska, United States, 99604
Pfizer Investigational Site
Kasigluk, Alaska, United States, 99609
Pfizer Investigational Site
Kongiganak, Alaska, United States, 99545
Pfizer Investigational Site
Kotlik, Alaska, United States, 99620
Pfizer Investigational Site
Kwethluk, Alaska, United States, 99621
Pfizer Investigational Site
Kwigillingok, Alaska, United States, 99622
Pfizer Investigational Site
Mtn. Village, Alaska, United States, 99632
Pfizer Investigational Site
Napaskiak, Alaska, United States, 99559
Pfizer Investigational Site
Newtok, Alaska, United States, 99559
Pfizer Investigational Site
Nunapitchuk, Alaska, United States, 99641
Pfizer Investigational Site
Russian Mission, Alaska, United States, 99657
Pfizer Investigational Site
Scammon Bay, Alaska, United States, 99662
Pfizer Investigational Site
Toksook Bay, Alaska, United States, 99637
Pfizer Investigational Site
Tuluksak, Alaska, United States, 99679
Pfizer Investigational Site
Upper Kalskag, Alaska, United States, 99607
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: NCT00743652     History of Changes
Other Study ID Numbers: 6096A1-3010, B1851009
Study First Received: August 27, 2008
Results First Received: September 9, 2011
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
13 valent Pneumococcal Conjugate Vaccine
Antibody Response
safety
Alaskan Native Children

ClinicalTrials.gov processed this record on April 16, 2014