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

NCT00366678 | Completed Phase 3 Results

• 1 other identifier: 6096A1-008
• Study Type: interventional
• Target: 613
• Locations: 1 country
• Sites: 45

Brief Summary

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.

Conditions

Vaccines, Pneumococcal

Keywords

Safety; Vaccine

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• 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

  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

  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

  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

  One month after the toddler dose (at 13 months of age)

Study Arms (2)

13-valent pneumococcal conjugate vaccine

EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine; Drug: Pentavac

7-valent pneumococcal conjugate vaccine

ACTIVE COMPARATOR

7-valent pneumococcal conjugate vaccine

Biological: 7-valent pneumococcal conjugate vaccine; Drug: Pentavac

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.

13-valent pneumococcal conjugate vaccine

7-valent pneumococcal conjugate vaccine BIOLOGICAL

Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.

7-valent pneumococcal conjugate vaccine

Pentavac DRUG

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).

13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• · Known contraindication to vaccines.

Sponsors & Collaborators

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

Study Sites (45)

Unknown Facility

Albi, 81000, France

Location

Unknown Facility

Amiens, 80000, France

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Unknown Facility

Ancenis, 44150, France

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Unknown Facility

Blanquefort, 33370, France

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Unknown Facility

Bondues, 59910, France

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Unknown Facility

Bordeaux, 33000, France

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Unknown Facility

Brest, 29200, France

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Unknown Facility

Châlons-en-Champagne, 51000, France

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Unknown Facility

Créteil, 94000, France

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Unknown Facility

Dijon, 21000, France

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Unknown Facility

Draguignan, 83300, France

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Unknown Facility

Essey-lès-Nancy, 54270, France

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Unknown Facility

Écully, 69130, France

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Unknown Facility

Floirac, 33270, France

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Unknown Facility

Fréjus, 83600, France

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Unknown Facility

Garges-lès-Gonesse, 95140, France

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Unknown Facility

Illkirch-Graffenstaden, 67400, France

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Unknown Facility

Joué-lès-Tours, 37300, France

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Unknown Facility

Le Havre, 76600, France

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Unknown Facility

Le Plessis-Trévise, 94420, France

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Unknown Facility

Le Pontet, 84130, France

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Les Lilas, 93260, France

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Les Sables-d'Olonne, 85100, France

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Libourne, 33500, France

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Lingolsheim, 67380, France

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Lyon, 69005, France

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Lyon, 69007, France

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Marcq-en-Barœul, 59700, France

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Maromme, 76150, France

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Moûtiers, 73600, France

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Nancy, 54000, France

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Nice, 06300, France

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Nogent-sur-Marne, 94130, France

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Oullins, 69600, France

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Unknown Facility

Paris, 75571, France

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Rouen, 76100, France

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Strasbourg, 67000, France

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Unknown Facility

Strasbourg, 67100, France

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Thionville, 57100, France

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Unknown Facility

Tours, 37000, France

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Unknown Facility

Tresses Melac, 33370, France

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Unknown Facility

Vandœuvre-lès-Nancy, 54500, France

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Unknown Facility

Vaulx-en-Velin, 69120, France

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Unknown Facility

Villeneuve-d'Ascq, 59650, France

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Unknown Facility

Vitry-sur-Seine, 94400, France

Location

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Pentavac

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 15, 2012
• Results First Posted: August 15, 2012

Record last verified: 2012-07

Locations

FR (45)