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

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:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

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

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 June 17, 2013