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NCT00743652 Clinical Trial

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

Pneumococcal Disease Clinical Trial

Official title:
A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00743652
Other study ID # 6096A1-3010
Secondary ID B1851009
Status Completed
Phase Phase 3
First received August 27, 2008
Last updated March 13, 2012
Start date January 2009
Est. completion date September 2010

Study information
Verified date March 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 373
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 42 Days to 5 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine
4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
• 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)
• 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)
• 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 )
• 13-valent Pneumococcal Conjugate Vaccine
1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)

Locations
Country Name City State
United States Pfizer Investigational Site Akiak Alaska
United States Pfizer Investigational Site Bethel Alaska
United States Pfizer Investigational Site Chefornak Alaska
United States Pfizer Investigational Site Chevak Alaska
United States Pfizer Investigational Site Eek Alaska
United States Pfizer Investigational Site Emmonak Alaska
United States Pfizer Investigational Site Hooper Bay Alaska
United States Pfizer Investigational Site Kasigluk Alaska
United States Pfizer Investigational Site Kongiganak Alaska
United States Pfizer Investigational Site Kotlik Alaska
United States Pfizer Investigational Site Kwethluk Alaska
United States Pfizer Investigational Site Kwigillingok Alaska
United States Pfizer Investigational Site Mtn. Village Alaska
United States Pfizer Investigational Site Napaskiak Alaska
United States Pfizer Investigational Site Newtok Alaska
United States Pfizer Investigational Site Nunapitchuk Alaska
United States Pfizer Investigational Site Russian Mission Alaska
United States Pfizer Investigational Site Scammon Bay Alaska
United States Pfizer Investigational Site Toksook Bay Alaska
United States Pfizer Investigational Site Tuluksak Alaska
United States Pfizer Investigational Site Upper Kalskag Alaska

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. No
Primary Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level =0.35 Mcg/mL 1 Month After the Toddler Dose 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. 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. No
Primary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose 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. 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. No
Secondary Percentage of Participants Achieving Serum IgG Antibody Level =0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only) 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. 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5. No
Secondary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =1.0 Mcg/mL 1 Month After the Infant Series 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. 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. No
Secondary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =1.0 Mcg/mL 1 Month After the Toddler Dose 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. 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. No
Secondary Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose 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. 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. No
Secondary Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 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. Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. Yes
Secondary Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 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. Day 1 through Day 7 after vaccination 2 for Group 4 Yes
Secondary Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1 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. Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. Yes
Secondary Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2 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. Day 1 through Day 7 after vaccination 2 for Group 4 Yes
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