Phase 3 N=373 Prevention

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

Pneumococcal Disease · 13-valent Pneumococcal Vaccine

Bottom Line

View on ClinicalTrials.gov: NCT00743652 ↗

Enrolled (actual)

373

Serious AEs

6.8%

Results posted

Feb 2012

Primary outcome: 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 — 100.0; 100.0; 100.0; 100.0 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
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	100.0; 100.0; 100.0; 100.0; 83.3; 100.0	—
PRIMARY Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
PRIMARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)	50.0; 50.0; 100.0; 88.9; 100.0; 66.7	—
SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series	90.9; 100.0; 100.0; 72.7; 83.3; 100.0	—
SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose	100.0; 100.0; 50.0; 100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose	100.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1	32.3; 48.1; 3.2; 9.1; 7.8; 7.8	—
SECONDARY Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2	36.7; 10.2; 10.4; 8.5; 0.0; 0.0	—
SECONDARY Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1	42.9; 27.7; 20.7; 11.6; 7.1; 0	—
SECONDARY Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2	23.1; 9.1; 0.0; 22.4; 57.1; 26.5	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00743652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.