Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00366548
First received: August 17, 2006
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.


Condition Intervention Phase
Vaccines, Pneumococcal
Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series [ Time Frame: One month after 3-dose infant series (at 5 months of age) ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (at 5 months of age) ] [ Designated as safety issue: No ]
    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:
  • 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 13 months of age) ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose [ Time Frame: one month after the toddler dose (at 13 months of age) ] [ Designated as safety issue: No ]
    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.


Enrollment: 500
Study Start Date: November 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
Active Comparator: 2 Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Aged 2 months (42 through 98 days) at the time of enrollment.
  2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
  3. In good health as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae.
  8. Major known congenital malformation or serious chronic disorder.
  9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
  10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366548

Locations
Poland
Bydgoszcz, Poland, 85-168
Debica, Poland, 39-200
Krakow, Poland, 31-422
Krakow, Poland, 31-202
Krakow, Poland, 30-663
Lodz, Poland, 91-347
Lubartow, Poland, 21-100
Lublin, Poland, 20-044
Oborniki Slaskie, Poland, 55-120
Poznan, Poland, 61-709
Poznan, Poland, 60-535
Siemianowice Slaskie, Poland, 41-103
Torun, Poland, 87-100
Trzebnica, Poland, 55-100
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00366548     History of Changes
Other Study ID Numbers: 6096A1-009
Study First Received: August 17, 2006
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: Poland: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Vaccine
Infant

ClinicalTrials.gov processed this record on September 18, 2014