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

NCT00366340 | Completed Phase 3 Results

• 1 other identifier: 6096A1-006
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 51

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 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.

Conditions

Vaccines, Pneumococcal

Keywords

safety; Vaccine

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

  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.

  One month after 3-dose infant series (5 months of age)

• Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

  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.

  One month after 3-dose infant series (5 months of age)

• 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.

  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.

  One month after 3-dose infant series (5 months of age)

• Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

  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.

  One month after 3-dose infant series (5 months of age)

• 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

  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).

  One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

• 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

  One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

• Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

  One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

• Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

  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.

  One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

• Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose

  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.

  Immediately before (12 months of age) and one month after the toddler dose (13 months of age)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  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.

  Day 1 through 4 after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)

  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.

  Day 1 through 4 after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)

  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.

  Day 1 through 4 after each dose

Study Arms (2)

1

EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

2

ACTIVE COMPARATOR

7-valent pneumococcal conjugate vaccine

Biological: 7-valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

1

7-valent pneumococcal conjugate vaccine BIOLOGICAL

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

2

Eligibility Criteria

• Age: 56 Days - 112 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 2 months (56 to 112 days) at time of enrollment.
• Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
• Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
• Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

You may not qualify if:

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• Known or suspected immune deficiency or suppression.
• History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.
• Major known congenital malformation or serious chronic disorder.
• 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.
• Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
• Participation in another investigational trial. Participation in purely observational studies was acceptable.
• Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Sponsors & Collaborators

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

Study Sites (51)

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Bad Kreuznach, 55543, Germany

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Bad Saulgau, 88348, Germany

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Bad Sobernheim, 55566, Germany

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Berlin, 10551, Germany

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Berlin, 10967, Germany

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Berlin, 13355, Germany

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Berlin, 13409, Germany

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Berlin, 13507, Germany

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Berlin, 13627, Germany

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Birkenfeld, 75217, Germany

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Bobingen, 86399, Germany

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Bramsche, 49565, Germany

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Bretten, 75015, Germany

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Cham, 93413, Germany

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Ehingen, 89584, Germany

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Erlangen, 91056, Germany

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Eschwege, 37269, Germany

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Flensburg, 24939, Germany

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Gau-Odernheim, 55239, Germany

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Hamburg, 22763, Germany

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Herzogenaurach, 91074, Germany

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Höchberg, 97204, Germany

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Kehl, 77694, Germany

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Kiel, 24111, Germany

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Kleve, 47533, Germany

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Krefeld, 47798, Germany

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Ludwigshafen, 67059, Germany

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Lübeck, 23568, Germany

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Mainz, 55101, Germany

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Metzingen, 72555, Germany

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Minden, 32427, Germany

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Münster, 48159, Germany

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Münster, 48165, Germany

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Neumünster, 24534, Germany

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Neumünster, 24534, Germany

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Neustadt/Aisch, 91413, Germany

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Niebüll, 25899, Germany

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Nuremberg, 90473, Germany

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Nuremberg, 90482, Germany

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Oberkirch, 77704, Germany

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Olching, 82140, Germany

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Pforzheim, 75172, Germany

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Porta Westfalica, 32457, Germany

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Ravensburg, 88214, Germany

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Tettnang, 88069, Germany

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Vellmar, 34246, Germany

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Weiden, 92637, Germany

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Weilheim, 82362, Germany

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Welzheim, 73642, Germany

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Wiesbaden, 65205, Germany

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Zirndorf, 90513, Germany

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Related Publications (1)

• Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.

  PMID: 21704105 DERIVED

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Germany, medinfoDEU@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: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 8, 2012
• Results First Posted: August 8, 2012

Record last verified: 2012-06

Locations

DE (51)