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:
NCT00366678
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 compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.


Condition Intervention Phase
Vaccines, Pneumococcal
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Drug: Pentavac
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 Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

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 Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group [ Time Frame: One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.

  • Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group [ Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group [ Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group [ Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group [ Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC [ Time Frame: One month after the 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.

  • 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 (Tender)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 (Sev) (>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 Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC [ Time Frame: One month after the 3-Dose Infant Series (at 5 months of age) ] [ Designated as safety issue: No ]
    Antibody GMC 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 (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups [ 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 ≥0.35μg/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.

  • Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups [ Time Frame: One month after the Toddler Dose (at 13 months of age) ] [ Designated as safety issue: No ]
    Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

  • Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups [ Time Frame: One month after the toddler dose (at 13 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 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

  • Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose [ Time Frame: One month after the toddler dose (at 13 months of age) ] [ Designated as safety issue: No ]
    GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.


Enrollment: 613
Study Start Date: October 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Biological: 13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
Drug: Pentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Active Comparator: 7-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
Drug: Pentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

  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:

· Known contraindication to vaccines.

  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: NCT00366678

Locations
France
Albi, France, 81000
Amiens, France, 80000
Ancenis, France, 44150
Blanquefort, France, 33370
Bondues, France, 59910
Bordeaux, France, 33000
Brest, France, 29200
Chalons en champagne, France, 51000
Creteil, France, 94000
Dijon, France, 21000
Draguignan, France, 83300
Ecully, France, 69130
Essey-les-nancy, France, 54270
Floirac, France, 33270
Frejus, France, 83600
Garges-les-Gonesse, France, 95140
Illkirch, France, 67400
Joue les tours, France, 37300
Le havre, France, 76600
Le plessis-trevise, France, 94420
Le pontet, France, 84130
Les lilas, France, 93260
Les sables d'olonne, France, 85100
Libourne, France, 33500
Lingolsheim, France, 67380
Lyon, France, 69007
Lyon, France, 69005
Marcq en baroeul, France, 59700
Maromme, France, 76150
Moutiers, France, 73600
Nancy, France, 54000
Nice, France, 06300
Nogent sur marne, France, 94130
Nogent-sur-marne, France, 94130
Oullins, France, 69600
Paris, France, 75571
Rouen, France, 76100
Strasbourg, France, 67000
Strasbourg, France, 67100
Thionville, France, 57100
Tours, France, 37000
Tresses melac, France, 33370
Vandoeuvre les nancy, France, 54500
Vaulx-en-velin, France, 69120
Villeneuve d'ascq, France, 59650
Vitry-sur-seine, France, 94400
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 France, infomedfrance@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00366678     History of Changes
Other Study ID Numbers: 6096A1-008
Study First Received: August 17, 2006
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: France: Ministry of Health
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 September 30, 2014