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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

August 27, 2008
March 13, 2012
January 2009
September 2010   (final data collection date for primary outcome measure)
  • 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.
Decline in disease rates [ Time Frame: quarterly ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00743652 on ClinicalTrials.gov Archive Site
  • 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.
Impact on incidence of disease, immunogenicity [ Time Frame: 6 months- 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pneumococcal Disease
  • 13-valent Pneumococcal Vaccine
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
  • 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)
  • 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)
  • 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 )
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
  • Experimental: Group1
    Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 2
    Subjects <12 months of age with 1 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 3
    Subjects <12 months of age with 2 prior doses of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 4
    Subjects ≥12 months to <2 years of age.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 5
    Subjects ≥2 years to <5 years of age
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
42 Days to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00743652
6096A1-3010, B1851009
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP