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

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ClinicalTrials.gov Identifier: NCT00574795
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Vaccines, Pneumococcal Conjugate Vaccine Biological: 13vPnC Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : September 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Intervention Details:
  • 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"

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after 3-dose infant series (at 7 months of age) ]
    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.


Secondary Outcome Measures :
  1. Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series [ Time Frame: one mone month after 3-dose infant series (at 7 months of age) ]
    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.

  2. Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose [ Time Frame: one month after the toddler dose (at 12 - 15 months of age) ]
    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.

  3. Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose [ Time Frame: one month after the toddler dose (at 12-15 months of age) ]
    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.


Other Outcome Measures:
  1. Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: Within 7 days after each dose ]
    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.

  2. Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: Within 7 days after each dose ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574795


Locations
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Japan
Nagoya-shi, Aichi, Japan, 466-8650
Toyohashi-shi, Aichi, Japan, 441-8570
Chiba-shi, Chiba, Japan, 261-0012
Matsuyama-shi, Ehime, Japan, 790-8524
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
Asahikawa-shi, Hokkaido, Japan, 078-8211
Sapporo-shi, Hokkaido, Japan, 006-0831
Sapporo-shi, Hokkaido, Japan, 062-0931
Sapporo-shi, Hokkaido, Japan, 063-0831
Yokohama-shi, Kanagawa, Japan, 240-8555
Yokosuka-shi, Kanagawa, Japan, 238-8558
Nangoku-shi, Kochi, Japan, 783-8505
Ise-shi, Mie, Japan, 516-0805
Tsu-shi, Mie, Japan, 514-025
Yokkaichi-shi, Mie, Japan, 510-8561
Kurashiki-shi, Okayama, Japan, 701-0192
Meguro-ku, Tokyo, Japan, 152-8902
Setagaya-ku, Tokyo, Japan, 154-0002
Setagaya-ku, Tokyo, Japan, 154-0017
Setagaya-ku, Tokyo, Japan, 157-8535
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00574795    
Other Study ID Numbers: 6096A1-3003
First Posted: December 17, 2007    Key Record Dates
Results First Posted: August 8, 2012
Last Update Posted: August 8, 2012
Last Verified: June 2012