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:
NCT00368966
First received: August 25, 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 compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.


Condition Intervention Phase
Vaccines, Pneumococcal
Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7-valent Pneumococcal Conjugate Vaccine
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, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain

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 Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [ Time Frame: One month after 2-doses of the infant series (5 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.

  • Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [ Time Frame: One month after 2-doses of the infant series (5 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series [ Time Frame: One month after 2-doses of the infant series (5 months of age) ] [ Designated as safety issue: No ]
  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]
    Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (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 (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.

  • Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]
    Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.

  • Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [ Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) ] [ Designated as safety issue: No ]
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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.

  • Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.

  • Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose [ Time Frame: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age) ] [ Designated as safety issue: No ]
    GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.

  • Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [ Time Frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 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, present in both 13vPnC and 7vPnC (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: 619
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 13-valent Pneumococcal Conjugate Vaccine
Active Comparator: 2 Biological: 7-valent Pneumococcal Conjugate Vaccine

  Eligibility

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

Inclusion Criteria:

  • Healthy 2-month-old infants
  • Available for the entire study period

Exclusion criteria:

  • Previous vaccination with any vaccine before the start of the study
  • Known contraindication to vaccination
  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: NCT00368966

Locations
Spain
Ferrol, A Coruna, Spain, 15405
Santiago de Compostela, A Coruna, Spain, 15706
Argentona, Barcelona, Spain, 08310
Sabadell, Barcelona, Spain, 08208
Sant Adria de Besos, Barcelona, Spain, 08930
Sant Cugat del Valles, Barcelona, Spain, 08195
Sant Cugat del Valles, Barcelona, Spain, 08197
Bilbao, Bizkaia, Spain, 48013
Burela, Lugo, Spain, 27880
Alcorcon, Madrid, Spain, 28922
Fuenlabrada, Madrid, Spain, 28943
Getafe, Madrid, Spain, 28902
Getafe, Madrid, Spain, 28900
Mostoles, Madrid, Spain, 28937
Parla, Madrid, Spain, 28980
Antequera, Malaga, Spain, 29200
Pamplona, Navarra, Spain, 31008
Vigo, Pontevedra, Spain, 36204
Burjassot, Valencia, Spain, 46110
La Eliana, Valencia, Spain, 46183
Quart de Poblet, Valencia, Spain, 46930
A Coruna, Spain, 15006
Almeria, Spain, 04007
Almeria, Spain, 04120
Almeria, Spain, 04009
Barcelona, Spain, 08025
Barcelona, Spain, 08017
La Coruna, Spain, 15270
Madrid, Spain, 28021
Madrid, Spain, 28041
Malaga, Spain, 29015
Ourense, Spain, 32005
Sevilla, Spain, 41013
Valencia, Spain, 46200
Valencia, Spain, 46021
Valencia, Spain, 46011
Valencia, Spain, 46024
Valencia, Spain, 46013
Valencia, Spain, 46022
Valencia, Spain, 46008
Valencia, Spain, 46023
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 Spain, infomed@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00368966     History of Changes
Other Study ID Numbers: 6096A1-501
Study First Received: August 25, 2006
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014