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:
NCT00366340
First received: August 17, 2006
Last updated: June 28, 2012
Last verified: June 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 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.


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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

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 ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (5 months of age) ] [ Designated as safety issue: No ]
    Percentage 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 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (5 months of age) ] [ Designated as safety issue: No ]
    Antibody concentration/geometric mean concentration (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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.

  • Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. [ Time Frame: One month after 3-dose infant series (5 months of age) ] [ Designated as safety issue: No ]
    Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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 Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (5 months of age) ] [ Designated as safety issue: No ]
    Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.

  • Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
    Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).

  • Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean concentration (GMC) as measured by mcg/mL 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.

  • Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [ Time Frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
    Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.

  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: Day 1 through 4 after each dose ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema 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 (Infant Series) [ Time Frame: Day 1 through 4 after each dose ] [ Designated as safety issue: Yes ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

  • Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) [ Time Frame: Day 1 through 4 after each dose ] [ Designated as safety issue: Yes ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.


Enrollment: 604
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13-valent pneumococcal conjugate vaccine
Biological: 13-valent pneumococcal conjugate vaccine
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Active Comparator: 2
7-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

  Eligibility

Ages Eligible for Study:   56 Days to 112 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 2 months (56 to 112 days) at time of enrollment.
  2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent(s) or legal guardian(s) had to be 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, polio, or hepatitis B vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or 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 or H influenzae type b.
  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, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
  10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
  12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366340

  Show 51 Study Locations
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 Germany, medinfoDEU@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: NCT00366340     History of Changes
Other Study ID Numbers: 6096A1-006
Study First Received: August 17, 2006
Results First Received: March 26, 2010
Last Updated: June 28, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014