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

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.

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.

Study Overview

• Status: Completed
• Conditions: Vaccines, Pneumococcal
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine; Drug: Pentavac; Biological: 7-valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 3

Contacts and Locations

Study 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, 69005
  • Lyon, France, 69007
  • 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, 67100
  • Strasbourg, France, 67000
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion criteria:

· Known contraindication to vaccines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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).; Biological: 7-valent pneumococcal conjugate vaccine; Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
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		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
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		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC	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.	One month after the 3-Dose Infant Series (at 5 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions	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.	During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events	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.	During the 4-day period after each dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC	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.	One month after the 3-Dose Infant Series (at 5 months of age)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	One month after the toddler dose (at 13 months of age)
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups	Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	One month after the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups	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.	One month after the toddler dose (at 13 months of age)
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose	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.	One month after the toddler dose (at 13 months of age)

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 18, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Vaccine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-008