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

NCT00368966 | Completed Phase 3 Results

• 1 other identifier: 6096A1-501
• Study Type: interventional
• Target: 619
• Locations: 1 country
• Sites: 41

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 vaccinations in Spain.

Conditions

Vaccines, Pneumococcal

Keywords

Pneumococcal; Pediatric; Vaccine

Outcome Measures

Primary Outcomes (11)

• Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

  Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.

  One month after 2-doses of the infant series (5 months of age)

• Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

  One month after 2-doses of the infant series (5 months of age)

• Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

  One month after 2-doses of the infant series (5 months of age)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (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 (Mod) (2.5 to 7.0 cm); Severe (\>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 Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose

  GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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 infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)

• Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

  Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.

  One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

• Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

  One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

• Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

  One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

• Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

  GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.

  One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

• Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose

  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, present in both 13vPnC and 7vPnC (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 infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)

Study Arms (2)

1

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

ACTIVE COMPARATOR

Biological: 7-valent Pneumococcal Conjugate Vaccine

Interventions

13-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

1

7-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

2

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:

• Previous vaccination with any vaccine before the start of the study
• Known contraindication to vaccination

Sponsors & Collaborators

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

Study Sites (41)

Unknown Facility

A Coruña, A Coruna, 15006, Spain

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Ferrol, A Coruna, 15405, Spain

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Santiago de Compostela, A Coruna, 15706, Spain

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Almería, Almeria, 04007, Spain

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Almería, Almeria, 04009, Spain

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Almería, Almeria, 04120, Spain

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Argentona, Barcelona, 08310, Spain

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Barcelona, Barcelona, 08017, Spain

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Barcelona, Barcelona, 08025, Spain

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Sabadell, Barcelona, 08208, Spain

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Sant Adrià de Besòs, Barcelona, 08930, Spain

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Sant Cugat del Vallès, Barcelona, 08195, Spain

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Sant Cugat del Vallès, Barcelona, 08197, Spain

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Bilbao, Bizkaia, 48013, Spain

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A Coruña, La Coruna, 15270, Spain

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Burela de Cabo, Lugo, 27880, Spain

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Alcorcón, Madrid, 28922, Spain

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Fuenlabrada, Madrid, 28943, Spain

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Getafe, Madrid, 28900, Spain

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Getafe, Madrid, 28902, Spain

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Madrid, Madrid, 28021, Spain

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Madrid, Madrid, 28041, Spain

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Móstoles, Madrid, 28937, Spain

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Parla, Madrid, 28980, Spain

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Antequera, Malaga, 29200, Spain

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Málaga, Malaga, 29015, Spain

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Pamplona, Navarre, 31008, Spain

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Ourense, Ourense, 32005, Spain

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Vigo, Pontevedra, 36204, Spain

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Seville, Sevilla, 41013, Spain

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Burjassot, Valencia, 46110, Spain

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L'Eliana, Valencia, 46183, Spain

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Quart de Poblet, Valencia, 46930, Spain

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Valencia, Valencia, 46008, Spain

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Valencia, Valencia, 46011, Spain

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Valencia, Valencia, 46013, Spain

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Valencia, Valencia, 46021, Spain

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Valencia, Valencia, 46022, Spain

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Valencia, Valencia, 46023, Spain

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Valencia, Valencia, 46024, Spain

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Unknown Facility

Valencia, Valencia, 46200, Spain

Location

Related Publications (2)

• Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

  PMID: 23965217 DERIVED

• 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: 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 Spain, infomed@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: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2006
• First Posted: August 29, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 16, 2012
• Results First Posted: August 16, 2012

Record last verified: 2012-07

Locations

ES (41)