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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccines, Pneumococcal Conjugate Vaccine
• Intervention / Treatment: Biological: 13vPnC

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 466-8650
    • Toyohashi-shi, Aichi, Japan, 441-8570
  • Chiba
    • Chiba-shi, Chiba, Japan, 261-0012
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 790-8524
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1394
    • Fukuoka-shi, Fukuoka, Japan, 813-0036
    • Fukuoka-shi, Fukuoka, Japan, 814-0162
    • Fukuoka-shi, Fukuoka, Japan, 819-0002
    • Maebaru-shi, Fukuoka, Japan, 819-1138
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 078-8211
    • Sapporo-shi, Hokkaido, Japan, 006-0831
    • Sapporo-shi, Hokkaido, Japan, 062-0931
    • Sapporo-shi, Hokkaido, Japan, 063-0831
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 240-8555
    • Yokosuka-shi, Kanagawa, Japan, 238-8558
  • Kochi
    • Nangoku-shi, Kochi, Japan, 783-8505
  • Mie
    • Ise-shi, Mie, Japan, 516-0805
    • Tsu-shi, Mie, Japan, 514-025
    • Yokkaichi-shi, Mie, Japan, 510-8561
  • Okayama
    • Kurashiki-shi, Okayama, Japan, 701-0192
  • Tokyo
    • Meguro-ku, Tokyo, Japan, 152-8902
    • Setagaya-ku, Tokyo, Japan, 154-0002
    • Setagaya-ku, Tokyo, Japan, 154-0017
    • Setagaya-ku, Tokyo, Japan, 157-8535

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.	Within 7 days after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 7 days after each dose

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 17, 2007

Study Record Updates

• Last Update Posted (Estimate): August 8, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 6096A1-3003