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

Phase 3

Completed

• Conditions: Pneumococcal Disease; 13-valent Pneumococcal Vaccine
• Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine

• Registration Number: NCT00743652
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2009-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-09-09
• Results First Submitted QC: 2012-01-05
• Results First Posted: 2012-02-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	13-valent Pneumococcal Conjugate Vaccine	Subjects \<12 months of age with 1 prior dose of Prevnar.
Group1	13-valent Pneumococcal Conjugate Vaccine	Subjects 6 weeks to \<10 months of age with 0 prior dose of Prevnar.
Group 3	13-valent Pneumococcal Conjugate Vaccine	Subjects \<12 months of age with 2 prior doses of Prevnar.
Group 4	13-valent Pneumococcal Conjugate Vaccine	Subjects ≥12 months to \<2 years of age.
Group 5	13-valent Pneumococcal Conjugate Vaccine	Subjects ≥2 years to \<5 years of age

Primary Outcome Measures

Name	Time	Method
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	28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.	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	28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.	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	28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.	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

Name	Time	Method
Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)	28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.	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	28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.	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	28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.	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	28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.	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	Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.	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	Day 1 through Day 7 after vaccination 2 for Group 4	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	Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.	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	Day 1 through Day 7 after vaccination 2 for Group 4	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Upper Kalskag, Alaska, United States