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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

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ClinicalTrials.gov Identifier: NCT00452452
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: 13-valent Pneumococcal Conjugate Vaccine Phase 3

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Study Type : Interventional
Actual Enrollment : 355 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

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Arm Intervention/treatment
Experimental: A Biological: 13-valent Pneumococcal Conjugate Vaccine



Primary Outcome Measures :
  1. Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination [ Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). ]
    Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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.

  2. Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups [ Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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.


Secondary Outcome Measures :
  1. Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period 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: During the 4-day period 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.



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Ages Eligible for Study:   7 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged from 7 months to <72 months at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian could be reached by telephone.
  3. Healthy as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with pneumococcal vaccine.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. Known or suspected immune deficiency or suppression.
  6. History of culture-proven invasive disease caused by S pneumoniae.
  7. Major known congenital malformation or serious chronic disorders.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
  9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.

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): NCT00452452


Locations
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Poland
Bydgoszcz, Poland, 85-168
Bydgoszcz, Poland, 85-316
Debica, Poland, 39-200
Krakow, Poland, 31-503
Leczna, Poland, 21-010
Lodz, Poland, 91-738
Oborniki Salskie, Poland, 55-120
Proznan, Poland, 61-709
Trzebnica, Poland, 55-100
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
Principal Investigator: Trial Manager For Poland: WPWZMED@wyeth.com
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00452452    
Other Study ID Numbers: 6096A1-3002
First Posted: March 27, 2007    Key Record Dates
Results First Posted: August 15, 2012
Last Update Posted: August 15, 2012
Last Verified: July 2012
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Pneumococcal Vaccines
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs