Clinical trial NCT00743652: Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Official title: A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
13-valent Pneumococcal Vaccine
Keywords: 13 valent Pneumococcal Conjugate Vaccine
Antibody Response
safety
Alaskan Native Children
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 373
Sex: ALL
Minimum age (years): 42
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
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
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Secondary outcomes:
measure: Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)
timeFrame: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1
timeFrame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2
timeFrame: Day 1 through Day 7 after vaccination 2 for Group 4
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1
timeFrame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2
timeFrame: Day 1 through Day 7 after vaccination 2 for Group 4
Other outcomes:
measure: Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC
timeFrame: Baseline to 6 months after last vaccination
measure: Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
measure: GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
measure: Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
measure: Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
measure: Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: Pneumococcal OPA GMTs 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.
measure: Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
measure: Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series
timeFrame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.
measure: Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose
timeFrame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.
measure: Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose
timeFrame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.
Locations:
city: Akiak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Bethel
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Chefornak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Chevak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Eek
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Emmonak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Hooper Bay
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Kasigluk
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Kongiganak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Kotlik
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Kwethluk
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Kwigillingok
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Mtn. Village
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Napaskiak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Newtok
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Nunapitchuk
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Russian Mission
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Scammon Bay
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Toksook Bay
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Tuluksak
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Upper Kalskag
country: United States
facility: Pfizer Investigational Site
state: Alaska
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: