Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

Official title:

A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574795
• Other study ID #: 6096A1-3003
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2007
• Last updated: June 28, 2012
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: June 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 6 Months

Eligibility

Inclusion Criteria:

• Healthy 2 to 6 month-old infant

• Available for entire study period

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal vaccine.

• Previous anaphylactic reaction to any vaccine or vaccine-related component.

• Contraindication to vaccination with a pneumococcal conjugate vaccine.

• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.

• Known or suspected immune deficiency or suppression.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological:
• 13vPnC
"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Antibody Level = 0.35 µg/mL in the 13vPnC Group After the 3-Dose Infant Series	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold = 0.35 µg/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.	one month after 3-dose infant series (at 7 months of age)	No
Secondary	Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series	GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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.	one mone month after 3-dose infant series (at 7 months of age)	No
Secondary	Percentage of Participants Achieving Antibody Level = 0.35 µg/mL in the 13vPnC Group After the Toddler Dose	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold = 0.35 µg/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.	one month after the toddler dose (at 12 - 15 months of age)	No
Secondary	Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose	GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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.	one month after the toddler dose (at 12-15 months of age)	No